CLINICAL SAFETY OPERATIONS MANAGER / 40 HOURS / DAY / BWH - TIMI STUDY GROUP

Responsibilities

The Clinical Safety Operations Manager oversees and supervises the activities of the teams of Clinical Safety Associates assigned to multiple. This Manager oversees all operational aspects of case review of safety event reports from sites as defined and delegated for contracted clinical trials and designated by the SAE Director. Responsible for managing the processing of event reports from notification by the sites to submission of a complete report to the sponsor. This includes providing oversight of all triaging, collecting, monitoring, processing, medical reviewing, and distributing of the reports to the respective sponsor or regulatory authorities within specified timelines and providing study management with information and guidance necessary to manage the overall project completion. The Manager serves the role of subject matter expert for TIMI relative to drug safety and pharmacovigilance requirements, guidelines, and trends. The Manager also fulfills management and performance review responsibilities for Clinical Safety Associates and other Safety department personnel. As needed, the Manager also performs the job functions of Clinical Safety Associates at a role model level.

Duties

1. Supervises staff of 18 or more assigned to teams to support multiplestudies.

2. Provide feedback to project teams, sponsors, and other TIMI personnel on proposed protocols, safety reporting processes, case report forms, and systems requirements for new trials or modifications to existing trials

3. Prepares and sets-up new trials, including scheduling of resources and timelines

4. Ensures team members are following appropriate SOPs and completing tasks as scheduled and in accordance with the contracts

5. Support and maintain appropriate quality review and process improvement procedures of safety activities

6. Establish appropriate relationships with administrative, clinical, and technical staff both internally (TIMI and BWH) and externally (sponsors)

7. Participate as needed in Investigator meetings and other site or study management training related to reporting safety events

8. Assists with problem resolution with appropriate department heads

9. Assist with the development and management of the annual departmental budget

10. Reviews safety sections of clinical protocols and may present safety monitoring at investigator meetings

11. Ensures that all FDA and international regulations are followed regarding clinical trial drug safety processes and procedure

12. Organizes and oversees the activities of the Clinical Safety Associates including assigning work to staff, mentoring and supervising staff, monitor work loads and resources, coordinate team meetings and other communications, oversight of the medical review process, and completing performance reviews

13. Maintains department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines

14. Develop and maintain study specific SOP documents in keeping with FDA requirements and audit procedures for the SAE reporting function

15. Oversee the administration of and monitor adherence to all TIMI Study Group SOPs, trial specific SOPs, GCPs, study protocol requirements, sponsors requirements regarding regulatory issues, and current FDA regulations required for SAE processing

16. Oversee the triage process for incoming documents from clinical trials sites to ensure timely and effective data collection for medical and scientific evaluation and reporting of safety reports from sites

17. Ensure that all new cases and query follow ups are processed and resolved according to defined timelines and that data management companies/sponsors receive follow-up information in a timely manner

18. Uses database