Senior Clinical Outsourcing Contracts Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee outsourcing and contracting functions that support clinical research, with a primary focus on clinical trials.

• Collaborate with Clinical Research Organizations and other service providers to guarantee effective, compliant, and high-caliber execution of clinical programs.

• Direct the negotiation and management of clinical research agreements.

• Work collaboratively across Clinical Operations, Legal, Finance, and study teams.

• Spearhead the RFI and RFP processes throughout all stages of clinical trials and associated services.

• Assist in vendor selection, coordinate RFPs and bid defenses, and negotiate work orders and change orders.

• Develop outsourcing strategies, including supplier selection and ongoing supplier oversight.

• Negotiate, manage, and execute intricate agreements with global service providers, vendors, research partners, and clinical trial sites.

• Ensure that contracts adhere to regulatory standards, ethical guidelines, company policies, and procedures.

• Oversee the complete contract lifecycle from request intake to execution, aligning with study deadlines.

• Review, draft, redline, and negotiate clinical agreements and templates.

• Identify contractual risks, escalate concerns, and drive resolutions.

• Negotiate advantageous terms and budgets focused on cost management, risk reduction, and preventing scope creep.

• Collaborate with Finance and Accounting on contract budgets and payment conditions.

• Ensure precision, consistency, and compliance across all contract documentation.

• Track contract turnaround times and promote process enhancements.

• Contribute to the optimization of contracting, budgeting, and payment processes.

• Perform additional duties as assigned.

⛳️ Requirements

• BS/BA degree in business administration or a health care/science-related field AND 8+ years of experience in a CRO, Biotech, or Pharmaceutical organization; OR a Master’s degree in business administration or a health care/science-related field AND 6+ years of comparable experience.

• Proficient in contract management, negotiation, budgeting, and administration, including billing/invoicing, issue resolution, and acting as the point of contact for CRO.

• Capability to suggest relevant process, technical, or service enhancements.

• Extensive expertise or specialized knowledge; recognized as an expert within the organization.

• Deep knowledge of the discipline and a broad understanding of related fields.

• Ability to function as part of and lead multiple teams.

• Strong leadership and mentoring capabilities.

• Exceptional computer proficiency.

• Outstanding communication, problem-solving, and analytical skills.

• Ability to meet multiple deadlines across various projects/programs with accuracy and efficiency.

• Excellent project management and strong project leadership abilities.

• Expertise in managing complexity and multiple work streams in dynamic environments.

• Advanced understanding of clinical trial processes, regulations, and guidelines.

• Demonstrated success in effectively working across a matrix organization.

• Ability to prepare and negotiate external provider master service agreements, work orders, and change orders, and monitor them for clinical operations.

• Skill in reading and interpreting complex clinical contracts and ensuring terms align with company standards.

• Expert contract administration abilities, including budgets, billing/invoicing, issue resolution, and acting as the CRO point of contact.

• Advanced knowledge of clinical contract accounting and budgeting processes.

• Comprehensive understanding of drug development and clinical operations.

🏝️ Benefits

• Annual bonus with a target of 30% of the earned base salary.

• Eligibility to participate in an equity-based long-term incentive program.

• Retirement savings plan with company match.

• Paid vacation.

• Paid holiday and personal days.

• Paid caregiver/parental and medical leave.

• Medical, prescription drug, dental, and vision coverage.