Senior Manager, Clinical Outsourcing (Remote Eligible)

Role Summary

Senior Manager, Clinical Outsourcing is accountable for successful execution of outsourcing processes within the development operations group including strategic outsourcing, vendor management and contract and budget negotiations. Specific CTA budget negotiation experience is preferred. This remote-eligible role oversees cross-functional vendor management and contracting activities.

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) and 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/metrics; communicating feedback to the supplier, encouraging adaptation of best practices across supplier types and development of continuous process improvements
  • 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

Qualifications

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