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 - 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
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
