The Clinical Contracts Specialist Sr (position title may be Clinical Contracts Manager) works closely with the project, people, and functional leaders across Clinical Operations & Biometrics, Procurement, Legal, Finance, and Suppliers to ensure appropriate contracts are in place for COBM projects and payments associated to contracts are issued to vendors.

DISTINGUISHING CHARACTERISTICS: This is a job requiring a combination of advanced skills and experience in drafting, negotiating, and finalizing contracts for COBM related services.

Responsibilities:

- Drafts, reviews and negotiates clinical trial agreements (Master Service Agreements, Work Orders, and Clinical Trial Agreements) and site budgets with US and ex-US institutions.

- Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate and finalize budget amendments.

- Provide continuing support on executed agreements (e.g., drafting amendments, extensions, and terminations, interpreting contractual language in response to issues or questions that arise).

- Work closely and communicate with members of the Lifecycle Finance teams and other internal stakeholders; provide timely updates on contract and site budget status’, identifying and escalating any potential critical path items as appropriate.

- Track, maintain and update assigned contract information within the COBM Clinical Trial Management System (CTMS) and other tracking tools, to ensure completeness and accuracy, as applicable.

- Works with Supplier Relationship Manager and Legal to establish a Master Services Agreement (MSA) for as many suppliers as possible. -  Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.

- Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO’s, and report spend as necessary.

- Other tasks may be assigned from time to time to support the overall COBM function.

- Manages staff; provides staff with coaching, training, and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform their responsibilities.

Formal Training/Education

- Bachelor's Degree in Business / Finance or industry-related field

- Master's Degree in Business / Finance or industry-related field degree preferred or equivalent combination of education and work experience. 

Experience:

- 5 years of contract drafting, negotiation, and finalizing experience within Diagnostics and/or Pharmaceutical industry 

- 5 years of specific RFI, RFP, Contracting and/or Budget management experience

- 4 years of clinical trial experience  

Knowledge, Skills and Abilities

- Clinical Trial Services 

-  Contracting: Master Services Agreement content and contract negotiations

 -  Vendor Budgets