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Project Manager II
Ref No.: 18-12911
Location: Cambridge, Massachusetts
The ISS Project Manager is responsible for the overall management and activities of Investigator Sponsored Studies (ISS) for assigned drug programs globally.
The ISS Project Manager is responsible for ensuring these studies are run in compliance with GCPs, SOPs and local regulations.
The role includes managing the Scientific Research Committee (SRC) meetings for the purpose of reviewing and approving ISS protocols submitted by external parties.
The ISS Project Manager is responsible for overseeing and managing the timely execution of contracts and financial payments, budgeting and financial forecasting in Client's finance systems, tracking ISS study progression, managing the ISS database, and for maintaining ongoing metrics and reports on a regular basis.
This position liaises with the Global Medical Directors responsible for the drug program and with various other members of the Scientific Review Committee (SRC), internal finance teams, legal representatives, Medical Science Liaisons, Country Medical Directors, Senior Leadership, and with ISS contacts globally.

Responsibilities include:
1. Manage and organize SRC meetings
2. Manage ISSs through the approval and contract negotiation stages
3. Work with Regulatory Affairs to generate cross reference letters and ensure all regulatory documents for studies are in place
4. Responsible for generating contracts and CDAs with Legal
5. Responsible for forecasting study drug requirements to CPRS group and arranging for shipping and monitoring of study drug supply
6. Responsible for forecasting ISS milestone payments via an accrual methodology in Client's financial tracking tool
7. Responsible for corresponding with sites to provide updates on ISS status pre-approval
8. Maintain communications with Client Pharmacovigilance for drug safety updates and distribute formal update letters to investigator sites as needed
9. Distributing Investigator Brochures (IB)
10. Communicating with GMO senior management, Medical Directors, global colleagues and MSL team regarding study updates
11. Responsible for preparing Purchase Orders (POs) and managing invoices
12. Training of SRC members and Medical Science Liaisons (MSL) on VisionTracker (database software)
13. Ensure ISS records and history are audit ready
14. Responsible for maintaining an efficient, compliant global ISS process that includes a continuous improvement plan
15. Responsible for mentoring junior team members
16. Support data quality check
17. Support in data entry process and data quality improvement
18. Support data extraction for Safety reporting and audit/inspection
19. Support in Vision Tracker evolution project

Knowledge and Skills:
 Leadership skills
 Project management skills
 Decision making and problem solving skills
 Ability to work autonomously
 Working knowledge or clinical development, FDA regulations and ICH/GCP guidelines
 Ability to work in an international environment
 Understanding of database concepts
 Knowledge of industry standards and practices preferred
 Excellent interpersonal and communication skills, including medical terminology
 Strong organizational and time management skills
 Self-motivation and attention to detail