Sr Clinical Contract Specialist

Type: Contract, w2 only

Duration: 12+ months (with possible further extension)

Location: Pleasanton, CA. Remote

Pay: $32.50/hr - $46.39/hr

Please note that at this time we are unable to sponsor employment authorization (both new and transfer). The position is not eligible for relocation.

Summary:

The Sr Clinical Contracts Specialist/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 with contracts are issued to vendors. This job requires a combination of advanced skills and experience in drafting, negotiating, and finalizing contracts for COBM-related services.

Qualifications:

• Bachelor's Degree in Business / Finance or industry-related field
• 5+ years of contract drafting, negotiation, and finalizing experience within Diagnostics and/or Pharmaceutical industry
• 4 years of clinical trial experience (preferred)
• 5+ years of specific RFI, RFP, Contracting, and/or Budget management experience

Responsibilities:

• Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate, and finalize budget amendments.
• Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO’s, and report spend as necessary.
• Other duties as assigned by management.
• Draft, review, and negotiate clinical trial agreements (Master Service Agreements, Work Orders, and Clinical Trial Agreements) and site budgets with US and ex-US institutions.
• 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 with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.
• Work with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.
• 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.
• 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.

Important: Beginning November 15, 2021, Client requires all US-based new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Client’s, and it applies regardless of whether the position is located onsite or fully offsite. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request accommodation

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs