Sr Research Data Manager 40 Hour Timi
Sr Research Data Manager 40 Hour Timi
Posted on :
09-04-2025
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1 Vacancy
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Job Description
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race sex color religion national origin sexual orientation protected veteranstatus or on the basis of disability.
QUALIFICATIONS:
Bachelors degree required
5 years of experience with data management previous work with CRO desired
3 years of experience with EDC systems e.g. Rave and InForm preferred
Experience with SAS preferred
Experience with database programming preferred
Indepth knowledge and understanding of the drug development process and data management process
Previous vendor management experience preferred
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
1. Knowledge of and proficient with computer hardware and software including applications and programming for database development maintenance query data imports
2. Aware of related Pharma Industry SOPs guidelines and best practices GCP and regulations
3. Ability to effectively interact with internal and external teams
4. Ability to manage multiple programs and processes simultaneously
5. Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions conclusions or approaches to problems
6. Excellent written and verbal communication and presentation skills
7. Ability to make independent and effective decisions
8. Excellent judgment and organizational skills
WORKING CONDITIONS:
Busy office environment with frequent deadlines and shifting priorities
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Senior Data Manager will be responsible for providing data management support to TIMI Study Group functional departments and physicians by assisting with the development and validation of systems used for event adjudication and general management of data used in the trials supported by the TIMI Study Group.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. Develop and review adjudication system database specifications and perform user acceptance testing (UAT) in collaboration with TIMI CEC Department and Partners IS. May assist in writing the test plan test scripts and test summary for UAT of the adjudication database prior to initial release and in response to postproduction changes.
2. Assist in the development of test scripts to be used for CEC UAT of clinical databases and/or perform UAT of relevant eCRF pages in clinical databases.
3. Create standard and ad hoc adjudication reports for dissemination to internal and external recipients.
4. Provide support to the project teams in granting and removing individual access to the electronic adjudication system.
5. Assist in the development and review of data transfer and patient profile specifications.
6. Liaise with adjudication system vendor and external vendors/sponsors to ensure smooth data transfer processes
7. Participate in project reconciliation activities.
8. Participate in departmental quality control activities.
9. Participate in the development of systemsrelated instruction manuals SOPs and guidelines.
10. Provide input on the selection of new tools and the maintenance and evolution of the existing systems and processes involved in the collection review analysis and storage of project data.
11. Responsible for tracking adjudication system requests and issues from implementation through resolution.
12. Participate in cleaning adjudicated data for clinical study reports interim analyses regulatory submissions and other study related activities as needed.
13. Assist physicians/project directors in completing data management tasks for clinical trials and academic presentations/publications.
14. Demonstrate and maintains high level of knowledge of regulations clinical research conduct laws guidelines and standards relating to department/trials(s)
15. Maintains department service standards with particular attention to personal/behavioral staff teamwork and customerstaff interaction guidelines.
16. Performs other tasks and responsibilities as directed.
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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