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Postdoc Appreciation Week: Speed Networking & Career Panel

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Learn about PhDs and Tufts alum that have successfully transitioned into careers in Industry!

 

In attendance: 
 
Antoine Boudot – in vitro Cancer Biologist at Merrimack Pharmaceuticals (former postdoc at Tufts)
April Blodgett – Sales and bioconsulting at PerkinElmer
Anh Hoang – Co-founder / CSO at Sofregen Medical
Michael Mattoni – Senior patent agent at Mintz Levin
Travis D’Cruz – Licensing associate at Tufts University
Michael Doire – Department manager – Biology at Tufts University
Angela Kaczmarczyk – Scientist / Founder of BosLabs
Nina Dudnik – Scientist / Founder and CEO of Seeding Labs
What drove your career path away from academia?
April: A lot of work and little pay.
Antoine: Too many postdocs in the Boston/Cambridge area that also want to do the same as you do.
Travis: Going through the motions and seeing his PIs on their offices for so long, writing grants and not doing actual science.
Nina: Never wanted to be an academic. What she cared most about was not about the details of the experiment but to explain/communicate to others why the science matters.
 
What do you do to step away from the academic path? What research did you do to prepare yourself to move out of academia?
 
Antoine
  • He works at the bench everyday as he used to do as a postdoc, but he enjoys not having to worry about funding and getting materials/reagents.
  • Set up a LinkedIn account and realized it was about building connections. He also went to networking events and started making connections within Merrimack. So start making connections now!
April:
  • Make connections now. Do not expect to connect with people now and then ask for help or a job the following day. Having a vaccine background helped her (microbiologist by training).
  • She loves the speed/demands of her job. She felt like making a change after several years and she likes doing sales, so she made the move and started thinking about previous experiences that translate to sales so that she could use them to get the job.
Ang:
  • After publishing in a high impact journal paper, nothing happens. What was conflicting for her was that all that work led to a high impact journal paper would not progress much beyond that. Thus, she wanted to do something about it and started a company.
  • She came from a large, well-funded research group, so she says she had resources. She also did studies toward a MBA. Postdoc’d at day and hustled at night.
  • Her postdoc did not prepare her for any of this! The learning curve was very steep. When starting a company you do wear 5 hats 40 hours a week. The postdoc prepared her for the science part (to sell the idea to investors), but not the business side of it. She didn’t know how to incorporate a company, how to pay her employees, how to provide them with benefits… People management is a whole different subject to deal with when setting up a company.
Michael M.:
  • Realized didn’t want to do research 3 or so years into the PhD, but he pushed through. He went to the tech transfer office and asked if they had an intern position. He now wears 3 hats at his job.
  • No need to be an attorney to become a patent agent.
  • Soft skills from the postdoc to apply for a job: the dealing with people, wearing twelve different hats.
Travis:
  • Sought out what other options are there. He found other postdocs who started a small consulting group and he joined them. That helped him stand out among a pool of job applicants when he finished his postdoc. Think outside the box!
Skills that you gained during your postdoc?
 
Michael D.
  • Took a different path: he did graduate school in molecular biology but as he progressed through grad school he realized that he didn’t want to necessarily do that.
  • Skills: Learning does not often solely happen in the class room. You learn valuable skills at your work place. Rarely the person who knows more in the lab is not the PI (not in terms of the everyday requirements). It’s usually the lab manager/technician.
  • He looks for people with passion and knowledge. Doesn’t care about people coming from top schools alone.
Michael M.:
  • A major skill is to ask the right questions! In his case: what does a specific sector need? How can he become an asset to their organization? Utility-centered approach. Take initiative. Know where you want to go. Be honest to yourself about not knowing. Get it out of your system.
Michael D.:
  • Much easier to teach PhDs about management than management people learning how to do science!
What to do when you already know what you want?
 
Angela:
  • Started by writing for the student magazine at Berkeley. Went to a bio-hacking talk and was intrigued by it. Moved to Boston and acquired teaching experience at Harvard, then found out about space open to do science at Somerville. Science classes open to all backgrounds (a lot of them are engineers interested in learning biotechnology!)
  • Events during the weekends and a forum this Monday 9/26/16 at LabCentral.
  • She is also a visiting scientist at the Broad Institute.
  • In the future she wants to do the community lab (BosLabs) full-time.
Nina:
  • She thinks the biggest problems in the world can be addressed by science. Knew she wanted to be a geneticist when she was 13 (wanted to feed the world).
  • Incredible compulsion to solve problems. 
  • When in Harvard she realized that many labs had a surplus of or were wasting equipment that could be used further, so she started Seeding Labs 5 years even before she officially started Seeding Labs.
  • Got funding for Seeding Labs even before she started writing her thesis.
  • Started doing networking events and met people that helped her learn about finances and management.
  • She had to learn about 7 different languages she would not have learned when in academia to run the labs.
Michael M.:
  • You will never be prepared for the next step! You make it as you go along.
 
 
 
 

[Job Listings] Associate Project Manager opening at Bracket Global

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[Job Listings] Associate Project Manager opening at Bracket Global

Check out this job posting from our friends at Bracket (formerly Clintara). Great for people who love project management and data analysis!

Position Overview:

Responsible for development and management of projects at assigned pharmaceutical clients.  The projects will include clinical data quality services (e.g. Rater training, subject eligibility, ratings quality assurance, endpoint reliability, scale management, etc.) for said pharmaceutical clients. 
Essential Duties and Responsibilities:
Project Management (50%)
·       Manage all phases of each assigned project, including budget, invoicing, staffing, project plan and client deliverables
·       Manage multiple projects concurrently, maintaining project schedule and quality deliverables in a dynamic environment
·       Coordinate with other Client Services personnel as well as Professional Services and Technical Delivery resources to ensure the timely and quality preparation of project deliverables based on assigned scope-of-services
·       Oversee development and approval of study materials
·       Manage team of Project Specialists and/or Project Assistants to facilitate project tasks
·       Ensure all project deliverables are of high quality and exceed client’s expectations in compliance with Quality Management governance procedures
·       Oversee study management and coordinate study status with project sponsors
·       Manage resources and tasks to ensure all logistics, materials and technologies necessary as defined by scope-of-services
·       Coordinate with project sponsors to ensure all project expectations are met
Data/Site Management (30%)
·       Manage identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project teams
·       Manage communications with client (e.g. pharmaceutical sponsor, CRO) and site personnel regarding site/study details
·       Facilitate data review meetings with clinical trial study team leaders
·       Own in-study/maintenance transactional project activities throughout entire project lifecycle, e.g.  project variable fees, inter-department workflow assignment, issue escalation
·       Set up master systems, additional study hardware, study site folders, and data folders for clinical trial execution
·       Design and configure unique project systems and manage data for each assigned project, utilizing proprietary IT applications (e.g. RDA, IR2, CDR PRISM, etc.)
·       Produce data reports (e.g., weekly, interim, final, etc.) for submission to pharmaceutical clients
·       Attend and deliver presentations at both site and client facing meetings
Account Management (10%)
·       Communicate new opportunities, as identified, at existing clients for Bracket  encompassing Change Orders and new projects
·       Facilitate new  Change Order creation and socialization for assigned projects in cooperation with Business Development Operations
·       Manage relationships within assigned client accounts including routine written, telephone and face-to-face communication
·       Provide account updates to Bracket account management teams
Administration (10%)
·       Provide ongoing career development, mentoring and performance feedback for supervised Project Specialists and/or Project Assistants
·       Track monthly and quarterly metrics (variable fee budgetary items) and provide to Project Manager for invoicing
·       Enhance the Bracket business model by institutionalizing business processes, implementing best practices and templates, and seeking ways to work more efficiently
·       Contribute to the development, enhancement and testing for enterprise IT applications
·       Coach, counsel and provide mentoring and guidance for direct reports
Experience
·        Three to five years of professional experience
·       One to two years of project management experience
Skills & Competencies
Required
·        Experience with managing work plans, project budgets, invoicing, resource allocation and deliverable management
·        College degree (B.S., B.A.)/University Degree for EU candidates required
·         Demonstrated analytical, organizational, creative problem solving and structured communication skills
·         Strong client and vendor relationship skills
·         Demonstrated experience in career development and team management
·         Ability to travel for business
·         Ability to work nights or weekends as required
·         Demonstrated proficiency with computers, especially Microsoft Office (Excel, PowerPoint, Word, Access)
·         Fluency in English (will be required to write, speak and understand English to conduct day-to day business)
·         Ability to manage own time proactively identify prioritized tasks
·         Entrepreneurial spirit, drive and work ethic
·         Focus on attention to detail
Preferred
·         Professional experience within the pharmaceutical industry.  Training and/or education background valued.
We offer a fully comprehensive benefits program with medical, dental, vision, company paid life insurance, short and long term disability.  Great Paid Time Off program that starts with 20 days of accrual per calendar year; great 401k plan with company match that is 100% vested immediately!  Paid parental leave and other competitive benefit programs.  Great salary and reward and recognition programs. 
EEO Minorities/Women/Veterans/Disabled

Surviving the HR Screen from job posting to interview – advice from industry experts

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Learn about what happens on the other side when you submit your application for a job posting from seasoned industry experts! What is the best way to format your résumé so that it doesn’t get trashed?

 

 

 


Invited recruiters:

 

Alicia Rethage – Consults for biotech companies. Director of human resources.
Sean Conneely – Responsible for all recruitment in the US for Abcam. Also works as a freelance writer in his spare time.
  • What does Alicia consider is the purpose of the résumé?  Present yourself without the other person knowing. It has 3 parts to it:
    • Summary (objective) – the highlight, the advertisement of the Super Bowl. Has to be impacting. Catchy. Relevant to the job or what you’re looking for. It has to be clean, clear and have an impact to it.
      • Practice it. Give it to other people to critique.
    • Experience – in chronological order.
      • What is it that you’ve done? Write using active verbs. What was the problem, how did you approached it and what was the solution. How did you get there by doing that part?
  • What does Sean consider is the purpose of the résumé?
    • Lose the Objective section! He doesn’t want it to say what is your career goal down the road.
    • The Summary is key!
    • A résumé with more than 2 pages is a no no.
    • If you can’t get the attention from HR within the first 1-2 minutes they won’t go through it.
  • Sean: Accuracy on our résumé is important. Abcam uses Indeed, Glassdoor, Biospace, MassBio and even Craigslist!
    • They don’t have a keyword filter! He goes through every résumé, so make sure it is relevant and catchy because he doesn’t have time to go through all of them.
  • Alicia: Recruiters try to work as fast as they can. So the shorter that period is the more they make in terms of bonuses. The recruiter looks for quality. 
  • Submit your résumé the moment the job posting date is up, because that’s when the job is “hot”. If the job has been posted for too long it may be because they haven’t found a good person for it.
  • What is the window of time between posting and when someone should apply? 
    • Alicia: If you see the job today apply tonight, right away. Do not wait. You have to be the first one in line.
    • Sean: Do it quick, but you have to make sure your résumé is updated and your cover letter is perfect. If it’s ready to go, then apply as quick as you can.
  • How to format a résumé? How to take that job posting and how to market yourself well to what they’re looking for.
    • Sean: Filter out the first one or two tasks on the job posting that the company is looking for. Make that point in your summary or cover letter, and experience if possible. He’s not a big believer in buzzwords, but make sure to mention at least some keywords (i.e. skills/techniques) they’re asking for. 
      • Make sure to convey the fact that you can work well with others. 
      • If you don’t have a particular skill make sure that at least have some other skill that would show that you’re “trainable”.
    • Alicia: Spell out words that match the job description. Keywords/buzzwords have to be noticeable and repeat that one or two times so that the machine notices them (but no more than that because otherwise you would be wasting real estate in your résumé).
      • Résumé “real estate” is VERY valuable. Squeeze/shorten words to save space for other important things.
  • How many resumes are not qualified for the job?
    • Sean: 99% are not qualified.
      • For example: If there’s 8 bullet points for a job description, and you don’t feel confident covering the first 3 points then there’s a good chance you will not get the job. It would be a tough sell.
    • Alicia: Really read the requirements of the job posting. Otherwise you would be frustrated that you’re sending résumés out and you’re not being contacted.
  • What is the “affirmative action” plan?
    • Sean: Because they have government contracts they have to make sure they comply with covering diversity and equal opportunity for applicants.
  • General format of the résumé?
  • Alicia: Presentation is crucial. Make sure it doesn’t have different fonts. Has to have a consistent, organized format. No typos!
    • Make sure your skills are highlighted.
    • For her the general format of the résumé is:
      • Summary: Should be no more than 4-5 lines and very well-written.
      • Experience (no need to write “Research Experience”)
      • Education
  • Sean: Do not go crazy with attention-grabbing details. Keep the format traditional and make it consistent and formatted.
    • For him the general format of the résumé is:
      • Summary: Should be no more than 4-5 lines. Very well-written.
      • Experience (no need to write “Research Experience”)
      • Skills (if needed)
      • Education
  • How long does it take to screen a résumé?
    • Alicia: For a machine: 1 second. For a person: 15 seconds. Your résumé is your business card!
      • Have the important things highlighted at the very beginning of each section.
    • Sean: 15-20 seconds. For a low-level job: maybe 15 seconds. For a higher-level job: maybe 20 seconds or so.
  • Are volunteering opportunities important? Do they look at them?
    • Alicia: It has to be relevant for the job. Maybe include it under “Others” at the end of your résumé.
    • Sean: If it’s a “meaty” volunteer activity, like team-building, leadership, etc. then yes. This is not necessarily what’s going to get you the job.
  • Does it have to be written in short, snappy sentences since it’s given so little time to read it?
    • Alicia: Has to show that you know the words. 
      • Keep it relevant. Stay away from including citizenship, residency/visa status. Not that it’s not important, but no one’s asking (at least not yet).
    • Sean: For example, for the Summary section he wouldn’t make it choppy. He wants to see nice, fluid, coherent sentences. 
      • For PhD level job applicants: can you sell the experience you got out of your PhD? More important than just listing your publications. 2 pages is the norm when including your publications.
  • What about jobs that are not relevant to the job posting but that can spark the interviewers’ interest?
    • If it gets you “through the door”: yes!
  • First tense vs third tense?
    • Alicia: Third tense (i.e. “Recognized as …”). If you feel like you’re good at doing this then yes.
    • Sean: Use the one that sounds more like you or the one you think would best describe you. No right or wrong answer for this.
  • What should you NOT include in your résumé?
    • Sean: Personal information.
    • Alicia: Facebook (careful what you post! They can cross-reference your online presence. Your email address has to be professional. 
  • What should be included?
    • LinkedIn
  • Stemming from question above regarding citizenship status:
    • Sean: Citizenship status does not get asked about at first. Visas are an economic burden for companies, so maybe make clear in your application that you’re good with your application status if you don’t need it.
    • Alicia: Better don’t give that info on your application.
  • What about long-distance applicants?
    • There are some hiring managers that are reticent to hire someone from out of state. The hiring managers don’t care where you live, but they want to make sure you know that the job is not in some other place you would rather be. Make that point clear: establish on the cover letter why would you like to have this job.
  • What about a Scientist I position that requires 1-2 years experience?
    • Sean: Depends on the job description and the company.
    • Alicia: Having an internship counts as experience.
  • Inclusion of references on your résumé?
    • Sean: “Available upon request”
    • Alicia: “Available upon request”
  • Résumé critiquing
    • Sean: 
      • No need to put graduation dates because it tells them about your age. Companies are not required to ask this information.
      • Skills should not be too high up on the résumé. Abbreviate the ones that are relevant to the job posting.
      • If you include the name of a Professor make sure it’s someone that’s highly recognizable. Otherwise it doesn’t hurt, but it’s not necessary (saves you space if you take it out).
      • Avoid text-heavy résumés.
      • If having a significant postdoc experience then should be included above the Education section (as Experience).
      • Keep it on a legible font.
      • Recruiters don’t look at every single thing you’ve done, rather whether you can convey the important points.
      • If you’re sticking to a 2-page résumé and you have an extensive publication record, pick the 5 publications that are more recent. Can also highlight the fact that there are more.
      • Résumé doesn’t have to go that far back (i.e. if you’ve had many experiences). Keep it relevant and recent.
    • Alicia
      • You’re describing your job, but you should say what was your role (your contribution).
      • Start your résumé with your summary.
      • Computer skills are not necessary to include nowadays. Get rid of the numbering format on the Research Experience.
      • Professional summary should be a story, not bullet points.
      • Recognizable schools should be highlighted on the Education section.
      • The smallest font size should be a 9. She prefers a 10 or 11.
      • No need to distinguish between Experiences: Technical, Research or Work.
      • Do not include publications that are in preparation.
      • Pick the 5 most recent publications.
      • Don’t exaggerate something you don’t have. Don’t try to oversell it.
      • “Collaborated” is frequently used. She prefers “teamed up”.
      • Include name, address and phone number on every page of the résumé.
      • Every bullet point should be 1-2 lines only, 3+ bullet points.
      • “Interested” sounds like a hobby.

 

Regulatory Affairs: A Day in the Life Of.

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Interested in a career in regulatory affairs? Click through to find out more!

Written by /u/LifeAfterLifeScience and copied with permission

Communicating

At the most basic level, you act as a trader in information. You’ll stand at the midpoint between a vast variety of departments, experts and regulators – and you’ll be keeping information flowing between each and every one of them. Emails, reports, meetings, phone calls, the job involves keeping people up to date and in the loop. Communication lies at the heart of regulatory affairs, so expect to do a lot of it.

Organising

Are you organised? You’d better be – you’ll be juggling multiple projects at any one time, plus various meetings and whatever emergency has come up this time. Being able to keep track of these requirements is a must. You’ll need to be able to plan both in the short term (today’s chaos) and the long term (what is our 4 year development plan?). This is where the typical scientific background, with its multitasking of experiments, writing, and meetings, really comes in handy.

Managing

The job title is Regulatory Affairs Manager, and so it’s fairly clear that there’s management involved. But it’s not ‘management’ in the sense of having people reporting to you and doing the tasks you assign them (well, not until later at least). Instead it’s managing people without actually having any formal authority over them – you can’t give orders, you’ll have to persuade, wheedle, nag, bargain, compromise and trade your way to your goals. This is not to say that people won’t want to help you, but each expert you approach will have a ridiculous number of demands on their time. Why should they help you? You need to be persuasive, and this is why interpersonal skills are one of the main talents HR looks for when hiring.

Writing dossier modules

Want approval to market your miracle drug? First you need to show that you know what you’re doing – that your product is safe, effective, and made in a (consistently) high-quality way. This is done via the dossier, a vast document split into numerous sections covering every stage of the development process and the future plans. As you’d expect, working on a product’s dossier takes up a lot of time. Whether it’s putting together the initial application or making updates to a previously-approved one, a regulatory career will revolve around the dossier.

Working with source documents

This is a pretty big change for people coming in from academia or research: you’re done with laboratory work. Others within the company will be doing protein analysis, clinical studies, purity checks – that’s not your job any more. Instead, you’ll take the work produced by these people (studies and reports), and use that as a basis for their own writing. You still need experience dealing with scientific data and methods (to understand what you are reading!), but the data is produced by others. Your job is to understand these source documents so that you can decide how much of it ends up in the dossier.

Providing regulatory advice

You aren’t just reading reports and writing dossiers. Because companies are always changing their methods (trying to optimise for cost and yield), you’ll be part of the change evaluation process – saying how much regulatory stress is involved in any given change. That clever idea to increase yields by a few percent is less worthwhile when the FDA demands several years of stability data first. Likewise, your advice will be needed to plan these changes. What will be needed to get approval for your drug? What kind of studies will be needed in the final submission? This is where regulatory affairs comes in.

Thoughts on transitioning into reg. affairs straight from the bench?
It depends on the company. Small biotechs will likely be looking for candidates with more experience however large pharma companies often hire people straight out of a PhD or postdoc and train them up.  

Kind of interesting?

If this sounds like your area and you want to know more, then either drop me a question here or check out our short guide for life scientists on Amazon. Or both 😀

[Job Listings] Clinical/Data Analyst/Scientist openings at Bracket

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Senior Clinical Scientist


Position Overview:
The Clinical Scientist designs and executes clinical services to enhance clinical trials. The Clinical Scientist partners with the sponsor clinical representatives to ensure appropriate project definition and ensures that clinical deliverables are in accordance with project scope. The Clinical Scientist directly participates in attendance at face-to-face and virtual training events, and may participate in business development opportunities.

Essential Duties and Responsibilities:Other duties may be assigned.

Clinical Responsibilities
·         Collaborates with study sponsors to establish appropriate project definition
·         Reviews protocol/CRF and provides feedback as appropriate
·         Designs and ensures appropriate execution of project specific processes and data review methodologies; ensures appropriate training
·         Ensures development of appropriate clinical content (e.g., qualification methodologies, didactic presentations) for rater training and qualification programs for study staff in clinical trials
·         Evaluates data submitted in accordance with Endpoint Reliability programs and contacts raters, as appropriate, to gather additional information and provide feedback
·         Ensures that project clinical deliverables are in compliance with quality control standards
·         Proactively identifies and escalates potential project issues appropriately to project team, sponsor and/or manager
·         Communicates with study site staff in accordance with project specific methodology/SOPs and documents interaction in the respective IT application
·         Ensures compliance with quality assurance as outlined in SOPs/Clinical Operations Guidelines
·         Ensures consistency of product with actual project scope and resolves ambiguities in collaboration with both internal and external project teams
·         Monitors performance of external Clinical Experts

Management (Team Lead Only)
·         Provides direct line management to Clinical Scientist I/II, Clinical Specialist, Clinical Associate, Sr. Project Assistant, and/or Project Assistant
·         Conducts appropriate supervisory meetings, and monitors productivity
·         Ensures appropriate training and career progression

Business Development
·         Participates in business development opportunities as assigned (e.g., client meetings, bid-defenses, preparation of materials)
·         Attends conferences and scientific meetings as appropriate

Administration
·         Submits weekly report of activity to manager
·         Participates in orientation and training of staff as appropriate
·         Participates on committees as assigned
·         Completes required trainings in a timely manner
·         Enhances the Bracket’s Client Services business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
·         Ability to perform all responsibilities of Clinical Scientist II, if required

Skills & Competencies

Education
·         Masters Degree, M.D., Ph.D., Psy.D, Pharm.D., in healthcare-related field, with three years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
·         RN with four years of clinical experience, which includes administration of psychiatric and/or cognitive scales

Experience
·         Minimum of one year as successful Clinical Scientist II or equivalent

Personal Attributes
·         Excellent writing skills
·         Demonstrated strong analytical, organizational, creative problem solving and communication skills
·         Ability to succeed in a fast-paced, entrepreneurial environment
·         Basic knowledge of statistics
·         Competency conducting patient interviews
·         Comfortable with being videotaped
·         Competency working with data and numbers
·         Good negotiation and diplomacy skills
·         Successfully manages own time, proactively identifies and prioritizes multiple tasks
·         Ability to work with staff at all levels and across various disciplines
·         Excellent computer skills including Word, Excel and PowerPoint
·         Fluency in English (will be required to write, speak and understand English to conduct day-to-day business)
·         Detail oriented
·         Willingness to travel
·         Willingness to maintain flexible schedule

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Position Title: Data Analyst II

Department:  Technical Delivery / Product Development
Reports To (Title):  Senior Manager, Manager, Team Lead
FLSA Status (exempt or non-exempt):  Non-exempt           

Position Overview:
The Data Analyst II is responsible for working with the Technical Delivery / Product Development staff to process data changes

Essential Duties and Responsibilities:
Note:  Other duties may be assigned.

·         Responsible for executing data change and data transfer requests.
·         Periodic database exports and transfers to client based on a pre-determined subset of the structure and content.
·         Writes and executes planned and ad-hoc SQL or SAS queries against MS SQL Database to extract data for Data Transfers and Reports.
·         Creates and executes Data Change Guides (DCGs) and determines corresponding risk/impact assessments.
·         Provides Data Transfers/Reports per approved Data Transfer Specifications.
·         Reviews, provides feedback and approves Data Transfer Plans and final Data Change Form documents submitted to clients.
·         Creates stored procedures to manipulate data for data-driven changes to IVR system functionality.
·         Creates DTS packages for imports into study databases.
·         Participates in special data-related projects as needed.
·         Demonstrate extreme attention to detail and organization in all aspects of work.
·         Follow Bracket Standard Operating Procedures for data change management, data transfer verification and risk/impact assessment documentation.
·         Some technical support after-hours, on-call time may be needed.
·         Other project work and responsibilities as required.

Skills & Competencies

Education
·         2-4 years of experience working in a data-driven environment.
·         In-depth working knowledge of Structured Query Language (SQL), as well as Microsoft Windows 2000/2003/XP and the suite of Microsoft Office applications.
·         Experience with standard data mining and data presentation techniques.
·         Proven ability to handle multiple competing priorities in a fast-paced work environment with minimal direct supervision.

Competencies & Personal Attributes
·         Must have excellent written communication skills, including the ability to effectively document procedures, processes and results.
·         Demonstrated ability to meet deadlines & multi-task in a fast-paced work environment.
·         Demonstrate extreme attention to detail and organization in all aspects of work.
·         Must have very strong skills with Microsoft Office applications.
·         Must be comfortable working with business users and technical teams.
·         Familiarity with SQL Queries is a plus.
·         Working knowledge of Visual Basic is a plus.
·         Familiarity with GCP and 21 CFR Part 11 is a plus.



Position Title:  Project Specialist, Client Services     


Department:  [eClinical or Scientific] Delivery Services
Reports To (Title):  Associate Project Manager, Project Manager or Sr. Project Manager, Client Services
FLSA Status (exempt or non-exempt):  Exempt                   

Position Overview:
Management and administration of projects at assigned pharmaceutical clients.  The projects will include clinical data quality services (e.g., EDC, ePRO, IxRS, rater training, endpoint reliability, scale management, cognition, etc.) for said pharmaceutical clients.

Essential Duties and Responsibilities:
Note:  Other duties may be assigned.

Data/Site Management (70%)
·         Manage identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project teams
·         Manage communications with client (e.g. pharmaceutical sponsor, CRO) and site personnel regarding site/study details
    • Facilitate weekly data review meetings with clinical trial study team leaders
·         Own in-study/maintenance transactional project activities throughout entire project lifecycle, e.g.  project variable fees, inter-department workflow assignment, issue escalation
·         Prepare study materials, including system requirements, data transfer documentation, questionnaires, rater experience surveys, response sheets, and other documents as required
·         Set up master systems, additional study hardware, study site folders, and data folders for clinical trial execution
·         Coordinate and set-up data for system launch as assigned
·         Design and configure unique project systems and manage data for each assigned project, utilizing proprietary IT applications (e.g. RDA, IR2, CDR PRISM, etc.)
·         Produce data reports (e.g., weekly, interim, final, etc.) for submission to pharmaceutical clients
·         Facilitate the closedown and archival of system databases
Training Event Management (15%)
·         Attend international large scale training events (e.g. Investigator’s Meetings, Phase I site staff training) and facilitate training sessions (requires frequent overnight domestic and international travel)
·         Coordinate with clients, vendors, and expert consultants to ensure all logistics, materials, and technologies necessary for successful training events are in place
·         Independently facilitate virtual training sessions (e.g. LiveMeeting) including attendee registration, training execution and issue resolution
Administration (15%)
·         Oversee project QC activities to ensure compliance within the enterprise Quality Management System
·         Work within project team to develop and implement processes for projects
·         Prepare and maintain in-study project plans, data management plans and study binders which will be executed in collaboration with Project Managers
·         Provide weekly status reports documenting project activities, planned steps and issues
·         Track monthly and quarterly metrics (variable fee budgetary items) and provide to Project Manager for invoicing
·         Training and development of teammates as appropriate
·         Leverage Project Assistant pool resources as required by project management
·         Enhance the Bracket business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
·         Contribute to the development, enhancement and testing efforts for enterprise IT applications (e.g. EDC, ePRO, IxRS, RDA, IR2, PRISM, CDR System, etc.)

Experience
·         Demonstrated proficiency as Senior Project Assistant or equivalent experience for a minimum of six (6) months

Skills & Competencies

Required Skills
·         College degree (B.S., B.A.)/University Degree for EU candidates or equivalent years of experience
·         Demonstrated analytical and organization abilities coupled with good client relationship skills
·         Exceptional customer service orientation
·         Demonstrated proficiency with computers, especially Microsoft Office (Excel, Access, Word, PowerPoint)
·         Fluency in English (will be required to write, speak and understand English to conduct day-to-day business.)
·         Ability to travel for business trips (overnight business trips expected monthly)
·         Ability to work independently and proactively in a small team environment with a strong attention to detail
·         Comfortable working in a fast-paced, changing environment
·         Flexible working style

Preferred skills:
·         Understanding of pharmaceutical clinical development and/or sales & marketing
·         Background in Pharmaceutical, Medical education and/or CRO