Senior Manager, Clinical Outsourcing

W2 Contract

Pay Rate: $80 - $95 per hour

Location: South San Francisco, CA - Remote Role

Job Summary:

The Senior Manager Clinical Outsourcing is accountable for the successful execution of outsourcing processes within the development operations group, including but not limited to strategic outsourcing, vendor management, and contract and budget negotiations.  Specific CTA budget negotiation experience is preferred.

Duties and Responsibilities:

• Manages the identification and selection process of clinical vendors such as CROs, central labs, Imaging, data management, biostatistics, etc.
• Generates Requests for Information (RFI), Requests for Proposals (RFP), and budget grids
• Coordinates bid defenses and proposal review meetings and provides analysis to project teams
• Manages operational aspects of clinical contracts and change orders, including active negotiation of scope of work, payment terms, and budgets
• Ensures quality oversight of vendors by:
  • Partnering with suppliers and internal staff to identify, manage, escalate, and resolve issues related to supplier performance;
  • Measuring supplier performance utilizing Scorecard/Metric activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance;
  • Facilitating and executing supplier governance meetings and operating reviews;
  • Developing effective partnerships with suppliers and internal staff.
• Possesses a thorough understanding of vendor contracts, contract types, and the ability to negotiate budgets
• Participates in the preparation and presentation of internal reports to management and other various business end users
• Supports Purchase Order management and contract/account reconciliation
• Supports quarterly external auditor reviewers and annual audits
• Manages Clinical Consultant agreements

Requirements and Qualifications:

• BS or BA required; MS, Ph.D, or PharmD. a plus
• 5+ years in the biotech/pharma clinical research industry, with 2+ years of clinical outsourcing and business operations experience required; must possess a strong knowledge of the clinical vendor landscape.
• Expertise in outsourcing and contracting best practices for all phases of clinical research with an understanding of the drug development process and the cross-functional responsibilities, including clinical trial design, study start-up and execution, site management, safety reporting, data management, and biometrics
• In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating SOW terms, and growing and fostering long-term, healthy strategic relationships
• Strong interpersonal, communication, and presentation skills to be able to engage with all levels, both within the company and entities, and with our CRO and clinical service providers.
• Understanding of clinical financials a plus (i.e., budgeting, accruals, and forecasting)

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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