Job Description

** Must be LOCAL and able to work onsite 3 days/week **

Position Overview

The Manager, Clinical Outsourcing plays a pivotal role in the planning, execution and management of clinical trial outsourcing strategies. This position focuses on ensuring that clinical trials are conducted efficiently and within budget while adhering to company standards and company policies. The Manager, Clinical Outsourcing collaborates with cross-functional teams, including study management team, clinical operations, finance, quality and legal to identify, evaluate and manage external service providers.

Reports to the Associate Director, Clinical Outsourcing.

Job Functions & Responsibilities

• Manage the contracting process across assigned clinical study vendors including vendor selection, budget and payment terms negotiation, and the contracting process including MSAs, study level contracts, PO generation, change orders, reconciliation and close out activities.
• Partner with key functions of the Study Management Team (SMT) with direct responsibility to ensure all contracts and agreements support predictable delivery and quality, and that vendors are aligned with strategic objectives, values, and policies.
• Work with Legal to incorporate negotiated scope and budgets into executable contracts with suppliers, ensuring efficiency, accuracy, and consistency in our agreements.
• Work with Clinical Outsourcing leadership, SMTs, and Quality Assurance to support vendor identification, qualification, and selection activities (prepare requests for proposal and organize Bid Defense Meeting).
• Oversee investigator grant budget negotiation and ensure compliance of budgetary guidance and process.
• Oversee assigned vendors (IRT, eCOA, Central Lab).
• Identify, assess, and escalate financial and operational risks as necessary.
• Work with Finance and the different study vendors to obtain reports required for financial transparency reporting (e.g., Sunshine Act, and local equivalents as applicable for EU and other countries).
• Review reports in compliance with the Sunshine Act (and other applicable laws regarding financial transparency), including payment disclosures and value transfer to healthcare professionals and organizations.
• Collaborate with vendor and internal stakeholders to verify data required for Sunshine Act (and other applicable law with regards to financial transparency) reporting
• Participate in implementing, managing, and overseeing program/portfolio-level contracts and budgets (e.g., Data Protection services, Data Monitoring Committee services, Clinical Ad Board services, HCP advisors etc.).

Experience Desired :

• 5+ years’ experience in clinical research and/or outsourcing within the pharmaceutical industry
• Experience in clinical study vendor oversight, including vendor selection, contract and budget negotiation, and financial management across the multiple facets clinical vendors may cover (CRO, ePRO, Central labs, Recruitment, Retention etc.)

Education :

• Bachelor’s degree in life sciences, clinical research, or a related field preferred

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