Contracts Specialist I, Site Agreements

Job Overview:

The Contracts Specialist I, Site Agreements will be remotely (home-based) located anywhere within the United States. 

1. Responsible for adherence to standard operating procedures (SOPs).

2. Perform the following, with occasional guidance from line management or more experienced colleagues: daily tracking, negotiation and approval of Site Agreements and Site Agreement templates (as applicable) for clinical study teams; timely updating of the departmental Site Agreement Management System ("SAMS") or any other system required for use on a particular study.

3. Identify and escalate issues (as defined in departmental processes) that must be escalated to line manager for review.

4. Confirm quality of tasks delegated to and completed by Contracts Associate.

5. Manage assigned studies with careful compliance with internal processes and procedures, or otherwise according to specified Sponsor requirements.

6. Responsible for the timely updating of the departmental contract tracking system.

7. Performs contract administration functions including: assisting with obtaining approvals on authorization forms as required; maintaining a contract tracking system to report contract status updates and signing status; providing notice of all executed contracts to the appropriate team members along with contract values; and scanning and filing executed contracts in the shared electronic storage area in a timely manner for access by other staff members.

8. Support line manager with departmental goals, objectives and initiatives in a positive and flexible way.

9. Provides management with regular status updates on all open contracts and any outstanding issues.

10. Complies with and fulfills corporate requirements of the position including, inputting activities in Timesheets, conducting all required training and documenting training in training systems, and preparing and submitting any company expense reports for reimbursement in a timely manner.

11. Drafts, negotiates, reviews, and processes contracts in a commercially reasonably manner that protects Covance’s fundamental interests and in accordance with departmental practices and policies. Produces and negotiates contracts that accurately reflect Covance’s obligations or rights and understandings with third parties.

12. Negotiates contractual terms with other contracting parties in a professional manner.

13. Identifies potential obstacles in the contracting process promptly and requests assistance of line manager, project management staff, Business Development staff, Budgets & Proposals staff or higher management as necessary to minimize delays and to facilitate the prompt conclusion of contractual negotiations.

14. Works closely with appropriate staff to keep them informed of progress of agreements and to avoid any delays in execution.

15. Provides support to other Site Agreements staff and assists internal staff with contractual inquiries as required.

16. Facilitates the internal review/revision/sign off process on contracts prior to forwarding to external parties.

17. Coordinate and communicate with clinical study teams in a timely manner regarding contract details and timelines, as well as contract status reporting to ensure quick approval of templates and contracts.

18. Ability to apply knowledge of the principles of ICH GCP to their work and follow quality standard procedures.

19. Perform other duties as required by the department.

 Education/Qualifications:Bachelor’s degree (LLB, JD, BA or BS) preferred, university-level law degree preferred (UK/EU). Experience:

 Minimum 0 - 2+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Clinical research (pharmaceutical and/or CRO) experience preferred. 

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