[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

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