Job Description

Job Description

Senior Manager, Contract Optimization and Strategy Team (COST)

W2 Contract-to-Hire

Salary Range: $156,000 - $176,800 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Senior Manager, COST - Vendor drives 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.

Duties and Responsibilities:

• 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 to complete 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 the vendor governance needs, where requested.
• Interview and evaluate candidates as part of the candidate evaluation teams.
• Train, coach, and mentor new hires, including managing performance reviews of direct reports, where applicable.

Requirements and Qualifications:

• 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. An advanced degree is 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 in 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 multitask, 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 with 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 in MS Word, Excel, PowerPoint, and Outlook is required.

Preferred Qualifications:

• Familiarity with 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.

Desired Skills and Experience

Contract optimization, vendor management, CRO management, clinical trial outsourcing, RFP/RFI process, contract negotiation, budget management, contract lifecycle management, vendor governance, KPI management, performance metrics, clinical operations, data management, biometrics, pharmacovigilance, regulatory compliance, quality assurance, cross-functional collaboration, Master Service Agreement negotiation, work order drafting, change order management, consulting agreements, vendor qualification, SOP compliance, purchase order management, vendor relationship management, Phase 3 clinical trials, multi-site trial management, ICH guidelines, GCP compliance, strategic planning, resource optimization, vendor performance optimization, team leadership, coaching and mentoring, performance management, financial systems, legal systems, Ex-US clinical operations, Grant Plan, Grant Manager, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Smartsheet

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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