sr manager, clinical contracts and outsourcing

SR MANAGER, CLINICAL CONTRACTS AND OUTSOURCING

Hybrid - Menlo Park / Foster City, CA area (2-3days a week)

Initial 6mth contract, potential of extensions and/or conversion

We are looking for a Senior Manager to join Clinical Contracts and drive objectives within projects' end-to-end outsourcing to external service providers for current and future clinical trials for Clinical Vendors (e.g., CRO's, imaging, cardiac, IRT, data management, Pharmacovigilance, etc.). Accountability includes partnering with the clinical development functions, Finance, CQA, Legal, IT and other functional teams for clinical vendor identification, creation of requests for information/proposal (RFIs/RFPs), service provider selection, contract negotiations, budget and contract lifecycle management, and facilitating service provider governance, including Key Performance Indicators (KPIs) and performance metrics.

This position would report to the Director, Vendor Contracting Relations.

The key responsibilities are:

• Drive decisions cross functionally with development operations teams (Clinical, DM, Biometrics, Safety, Regulatory, Quality) as well as Finance and Legal to review vendor contract proposals and budgets.
• Participate in the request for proposals process in support of clinical studies.
• Draft and finalize work orders, change orders and consulting agreements according to the scope of services requested.
• Drive collaboration through objective setting and communicate effectively with all functional area representatives within senior management in the project team environment as needed to ensure alignment across functions to support clinical programs.
• Work with Legal and Finance to review, amend and negotiate Master Service Agreements with vendors.
• Coordinate with QA and IT for completion of vendor qualification as required under SOPs.
• Contribute expertise to ensure vendor agreements cover all operational activities requested pertaining to the execution of clinical trials.
• Oversee internal and external logistics and/all activities/services required for execution of vendor agreements and purchase orders.
• Initiate, cultivate and maintain strong relationships with vendors and the study teams they support in driving to best practices, including communicating those to the broader organization.
• Provide support to client's vendor governance needs, where requested.
• Train, coach and mentor new hires, including managing performance reviews of direct reports, where applicable.

Required Skills, Experience and Education:

• Minimum of a BS, plus 8 years of experience in a contract administration environment in a pharmaceutical, CRO/ biotech company or worked in a clinical operations setting with a CRO/Sponsor company Advanced degree desirable.
• Expertise in large, multi-site, Phase 3 clinical trials is required.
• The ideal candidate will have experience working in growing companies or departments and can be flexible working with all levels of the organization.
• Direct experience vetting and negotiating with vendors is a must.
• Ability to understand the clinical development process and demonstrate the capability of managing multiple contracts and studies.
• Demonstrated leadership qualities, including the ability to say "no."
• Prior management experience and knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP.
• Demonstrated ability to multi-task, prioritize work, and independently solve problems.
• A strategic thinker who can efficiently utilize company resources and expertise to extract optimal vendor performance.
• An excellent communicator, both written and verbal, to effectively communicate to internal and external colleagues as required.
• Excellent organizational skills and attention to detail.
• An innovative, driven and effective person with a "can do" attitude.
• Proficiency with MS Word, Excel, Powerpoint and Outlook required.

Preferred Skills:

• Familiarity working with financial and legal systems/portals.
• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
• Working knowledge of applicable regulatory, ICH and GCP.
• Grant Plan or Grant Manager experience.
• Advanced knowledge of Microsoft Word, Excel, PowerPoint and Smartsheet.