Clinical Contract Manager

Summary

We are seeking a Clinical Contract Manager (CCM) to lead the end-to-end clinical site contracting process in support of our growing clinical portfolio.

Role

• Serve as Sponsor key contact for CRO functions involved in Clinical Trial Agreement (CTA) development, negotiation, execution and maintenance.
• Facilitate communication and collaboration between internal and external contributors (e.g., Legal, GDPR, Finance, Clinical Trial Team (CTT) members).
• Organize and coordinate meetings with key stakeholders, including decision tracking and action item follow-up.
• Contribute to development of templates, training material, and playbook.
• Develop site contracting plan in line with approved budget and fair market value.
• Align with Clinical Trial Leader (CTL)/ Clinical Trial Manager (CTM) and/or Site Management Leader (SML) on site activation plan and priorities.
• Oversee and track end-to-end CTA workflow and report progress to CTL/ CTM and/or SML.
• Identify risks and issues related to contracting plan and lead the development and implementation of mitigation strategies and action plans.
• Manage CTA review and approval by internal contributors (e.g., Legal, CTL).
• Manage accurate and up-to-date CTA information in systems and communication tools.
• Train external contributors (e.g., CRO functions involved in CTA process).
• Participate in CTT meetings and CRO meetings, as needed.
• Keep Sponsor Legal informed of site activation plan and priorities.
• Ensure CTA compliance with applicable regulations (e.g., SOX compliance, Sunshine Act, and Fair Market Value).
• Support investigator budget forecasting, accrual processes, and reconciliation.
• Ensure ongoing inspection and audit readiness of CTAs; participate in internal audits and regulatory inspections, as required.

What You Bring

• 5+ years of trial management experience with 3+ years in site management.
• Bachelor’s degree in Life Sciences, Pharmacy or related field.
• Experience working in global clinical development organization.
• Experience in Oncology development (preferred).
• Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred).
• Experience in outsourcing and oversight.
• Familiarity with clinical trial systems (e.g., CTMS, eTMF) and operational metrics, KPIs, and KRIs.
• Familiarity with site contracting requirements and healthcare compliance (Fair Market Value, SOX Act, Sunshine Act).
• Knowledge in ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines.