Sr Project Director 40 Hour Day Bwh - Timi
Sr Project Director 40 Hour Day Bwh - Timi
Posted on :
09-04-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
QUALIFICATIONS:
1. Bachelors degree required Masters strongly preferred
2. 10 years Industry CRO or biotech experience (domestic/international clinical trials)
3. Quality Assurance experience
4. Regulatory Experience
5. Supervisory Experience
6. Relevant Certification
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
1. Ability to accept a high degree of authority and responsibility for major decisionmaking as it relates to regulatory affairs and quality assurance in conduct of large domestic and international clinical trials.
2. Excellent judgment and ability to interpret national and international regulations and initiate appropriate actions given competing priorities.
3. Outstanding interpersonal and leadership skills to effectively interact with research coordinators principal investigators and to represent TIMI Study Group to sponsors and regulatory authorities (domestic and international).
4. Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds and to function effectively as a member of a research team.
5. Ability to train physicians and trial personnel on GCP and regulatory affairs.
6. Outstanding organizational abilities to formulate and complete rigorous timetables.
7. Ability to travel nationally on short notice.
WORKING CONDITIONS:
Clinical/research office environment with extended hours as needed to meet deadlines.
SUPERVISORY RESPONSIBILITIES:
In conjunction with Director of Operations and Study Chairman supervises research assistants(s)/coordinator(s) and TIMI Research Fellow(s)/resident(s).
FISCAL RESPONSIBILITY:
In conjunction with Director the Senior Project Director QA and Regulatory is responsible for oversight of departmental budget.
GENERAL SUMMARY/ OVERVIEW STATEMENT:
Responsible for regulatory oversight of 6 multicenter MEGA clinical trials both domestic and international. The Senior Project Director QA and Regulatory is responsible for daytoday quality assurance for all assigned trials and functional areas. This position has complete responsibility for meeting all deliverables and reporting requirements of various sponsors ensuring trials are conducted in accordance with GCP as well as ensuring all regulatory requirements are met in all countries for each assigned ongoing clinical trial.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. In collaboration with the Director Chairman and TIMI Physician Investigators is responsible for the daytoday management of the Quality Assurance and Regulatory team within the TIMI Study Group.
2. Is knowledgeable of all regulatory aspects of each clinical trial to be able to evaluate questions and problems. Collaborates with project team members to ensure regulatory compliance. These persons include study directors/managers research assistants/coordinators physician investigators and administrative assistants in the TIMI Study Group.
3. Independently designs and implements a Quality Management plan for the TIMI Study Group. Ensures quality standards are met for both internal operations and external vendors/collaborators.
4. Responsible for the auditing of external vendors and for managing sponsor audits of TIMI individual trials. Organizes and conducts internal team and functional area audits.
5. Maintains current knowledge of FDA regulations and GCP. Trains staff in these areas
6. Responsible for management and oversight of employee training database.
7. Provides appropriate staffing to identify organize and ensure accurate completion of required regulatory documents from clinical centers (domestic and international) as necessary to perform the trials. Works with sponsors on an ongoing basis to ensure appropriate regulatory documents are received and provided.
8. Develops an internal regulatory structure to meet the needs of each study. This includes efficient distribution of information on a timely basis to team members vendors and core laboratories.
9. Monitors FDA audits of study sites. Works with the study teams to ensure TIMI support of sites in preparing for and participating in audits. Interprets weekly statistics on patient enrollment case report form submissions delinquency reports and edit reports. Develops action plan to address problem sites.
10. Oversees preparation of correspondence to regulatory agencies sponsors and sites as requested by Director and/or TIMI Study Chairman.
11. Participates in QA or regulatory conference calls and appropriate studyrelated meetings. Ensures all supportive documentation is available to persons participating in call.
12. Monitors departmental budget. Suggests modifications in expenditures as necessary or as directed by Director and/or TIMI Study Chairman.
13. Maintains department service standards with particular attention to personal/behavioral staff teamwork and customerstaff interaction guidelines.
14. Performs other tasks and responsibilities as directed by the Director of Operations and/or Study Chairman.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
