Clinical Outsourcing Manager

Advanced Recruiting Partners; Raleigh (NC); On-site; USD 110,000 - 165,000; Full time

Job summary

Advanced Recruiting Partners is seeking a Clinical Outsourcing & Vendor Management lead in the United States. You will oversee outsourcing activities for clinical studies and manage vendor relationships from qualification through onboarding, ensuring alignment with timelines and budgets.

The role requires coordinating with Clinical Operations, Legal, and Procurement to drive compliant contracting, budget planning, and performance reviews, while escalating issues and driving process excellence.

Qualifications

• Lead outsourcing activities for clinical studies and other clinical development projects.
• Develop and execute sourcing strategies that align with program objectives, timelines, quality expectations, and budget requirements.
• Conduct vendor assessments and lead vendor selection processes.
• Manage RFIs, RFPs, bid defenses, and vendor evaluations.
• Partner with clinical study teams and other stakeholders to identify outsourcing needs and recommend appropriate solutions.
• Guide new vendors through qualification and onboarding processes.
• Act as a primary escalation point for vendor-related issues and facilitate timely resolution.

Responsibilities

• Lead outsourcing activities for clinical studies and other clinical development projects.
• Develop and execute sourcing strategies that align with program objectives, timelines, quality expectations, and budget requirements.
• Conduct vendor assessments and lead vendor selection processes.
• Manage RFIs, RFPs, bid defenses, and vendor evaluations.
• Partner with clinical study teams and other stakeholders to identify outsourcing needs and recommend appropriate solutions.
• Guide new vendors through qualification and onboarding processes.
• Act as a primary escalation point for vendor-related issues and facilitate timely resolution.

Job description

Clinical Outsourcing & Vendor Management

• Lead outsourcing activities for clinical studies and other clinical development projects.
• Develop and execute sourcing strategies that align with program objectives, timelines, quality expectations, and budget requirements.
• Conduct vendor assessments and lead vendor selection processes.
• Manage RFIs, RFPs, bid defenses, and vendor evaluations.
• Partner with clinical study teams and other stakeholders to identify outsourcing needs and recommend appropriate solutions.
• Guide new vendors through qualification and onboarding processes.
• Act as a primary escalation point for vendor-related issues and facilitate timely resolution.

Contracting & Negotiations

• Manage contractual documentation from initiation through execution, including:
• Master Service Agreements (MSAs)
• Statements of Work (SOWs)
• Work Orders
• Amendments and Change Orders
• Confidentiality Agreements
• Consultancy Agreements
• Service Agreements
• Lead contract negotiations to secure favorable terms, pricing, deliverables, and timelines.
• Collaborate with Legal, Procurement, Finance, and operational stakeholders throughout the contracting process.
• Support the development and maintenance of standard contract templates and contracting practices.

Financial Planning & Budget Management

• Support study teams in developing study cost estimates and budget forecasts.
• Review vendor proposals and pricing structures to ensure cost competitiveness.
• Monitor outsourcing expenditures against approved budgets.
• Participate in financial review meetings and budget planning activities.
• Identify cost-saving opportunities while maintaining quality and operational effectiveness.
• Contribute to business case development and financial assessments of vendors.
• Establish and monitor vendor performance metrics and service-level expectations.
• Conduct regular vendor performance reviews and debriefs with internal stakeholders.
• Identify and proactively address risks related to timelines, quality, compliance, and budget.
• Support strategic supplier relationship management initiatives.
• Foster collaborative and transparent relationships with vendors and preferred partners.

Compliance & Process Excellence

• Ensure outsourcing activities comply with applicable regulations, industry standards, and organizational procedures.
• Maintain knowledge of:
• ICH-GCP guidelines
• FDA regulations
• EMA regulations
• Clinical research industry best practices
• Support audits, inspections, and vendor compliance activities when required.
• Drive continuous improvement initiatives to increase efficiency and effectiveness of outsourcing processes.
• Identify opportunities for process optimization and operational excellence.

Stakeholder Engagement

• Collaborate closely with Clinical Operations, Clinical Development, Data Management, Biostatistics, Finance, Procurement, Legal, Quality Assurance, and other cross-functional groups.
• Represent the outsourcing function at study team meetings and project governance forums.
• Provide guidance and training regarding outsourcing processes, vendor management practices, and contracting procedures.
• Build strong internal and external relationships to facilitate project execution.