Clinical Contracts Manager
Edison-New Brunswick Metro Area, NJ
CLINICAL CONTRACT MANAGER
1. Perform and manage all activities associated with the development and execution of confidentiality agreements and contracts with clinical investigators, vendors, consultants, and other agreements as necessary.
2. Develop processes, procedures and contract agreement templates
3. Negotiate contracts and/or budgets and assist staff in preparation of SOWs in alignment with existing master service agreements
4. Facilitate / negotiate contracts and/or budgets for medical affairs research such as, but not limited to: registries, investigator initiated trials, cooperative research clinical studies. Prepare amendments, confidentiality agreements, vendor agreements, consulting agreements, cooperative agreements, investigator initiated research agreements.
5. Finalize agreements/contracts/ amendments
6. Identify changes to the Legal department and coordinate any changes requested in areas of the contract that are critical to company interests.
6. Attend scheduled team meetings to receive and provide information and advice on contractual, legal, and budgetary issues.
7. Track, manage and monitor all changes to agreement scope and ensure timely amendment finalization and implementation.
8. Update tracking system with all agreements/contracts/budgets information.
9. Maintain an electronic library of agreements/contracts previously negotiated, existing, and in-progress.
10. Communicate with internal team members, vendors, Investigators/Institutions as necessary to resolve contract/budget issues.
11. May participate in strategic initiatives as required.
12. Apply FMV (fair market value) financial benchmarking to contracts budgets, as appropriate.
Experience in pharmaceutical contracts, medical affairs contracting experience required
Experience in medical affairs / pharmaceutical research agreements (investigator initiated trials, registries, etc.) and budget management hematology/oncology therapeutic area experience strongly preferred
Excellent interpersonal, facilitation, negotiation and communication skills
Demonstrated competencies in analytical thinking, thoroughness, detail orientation, quality
Excellent Microsoft Office skills: Word, Intermediate level of Excel (formulas , formatting), and Intermediate level of PowerPoint