SummaryWe are seeking a Clinical Contract Manager (CCM) to lead the end-to-end clinical site contracting process in support of our growing clinical portfolio. This role will serve as the primary sponsor contact for Contract Research Organization (CRO) partners and internal stakeholders across Clinical, Legal, Finance, and Compliance.
In a fast-paced, small biotech environment, the CCM will drive the development, negotiation, execution, and maintenance of Clinical Trial Agreements (CTAs), ensuring alignment with trial timelines, budget, and regulatory requirements. This individual will play a key role in enabling timely site activation, CTA maintenance as per trial requirements, proactively identifying and mitigating risks, and ensuring compliance of CTAs with applicable regulations and internal standards.
The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.
Your 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.
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Salary range
$128,800-$193,200 USD
