Job Description: Senior Clinical Project Manager – Hematology
Location: Remote (UK)
Department: Clinical Development / Clinical Operations
Reports To: Director, Clinical Operations / VP, Clinical Development
Position Summary
We are seeking a highly motivated and experienced Senior Clinical Project Manager (Sr. CPM) to join our Clinical Operations team. The Sr. CPM will be responsible for the operational planning, execution, and oversight of three hematology clinical programs spanning early- to late-phase development. This individual will play a pivotal role in ensuring that studies are delivered on time, within budget, and in compliance with applicable regulations, SOPs, and GCP standards.
The ideal candidate will bring strong leadership, cross-functional collaboration, and vendor management expertise, along with deep experience in hematology and/or oncology trials.
Key Responsibilities
Clinical Trial Leadership & Execution
* Lead the planning, initiation, execution, and closure of multiple clinical trials across three hematology assets.
* Serve as the primary operational contact for cross-functional study teams, investigators, and CROs/vendors.
* Develop and manage study timelines, milestones, risk mitigation strategies, and budget forecasts.
* Ensure clinical trial deliverables are met according to quality standards, ICH-GCP, regulatory guidelines, and company SOPs.
Vendor & CRO Oversight
* Select, contract, and manage CROs and third-party vendors (labs, imaging, data management, central monitoring, etc.).
* Oversee vendor performance and drive accountability for deliverables, timelines, and quality.
* Negotiate budgets and contracts to align with program goals.
Cross-Functional Collaboration
* Partner with Clinical Development, Regulatory Affairs, Biometrics, Pharmacovigilance, and Medical Affairs to support seamless trial execution.
* Collaborate with Translational/CMC colleagues to align clinical operations with asset-specific requirements.
* Support regulatory submissions (INDs, NDAs/BLAs, CTAs), briefing packages, and responses to health authorities.
Operational Excellence
* Lead study team meetings, prepare agendas, track action items, and maintain documentation.
* Provide input into protocol design, ICFs, CRFs, monitoring plans, and study manuals.
* Monitor site performance, patient enrollment, and data quality; proactively identify and resolve issues.
* Support audit and inspection readiness across programs.
Leadership & Mentorship
* Mentor and support junior clinical operations staff as required.
* Contribute to process improvement initiatives within Clinical Operations.
* Represent Clinical Operations in cross-functional and governance meetings.
Qualifications & Experience
* Life sciences degree (BSc or higher); advanced degree a plus.
* 7+ years of clinical trial management experience, including 3+ years in hematology/oncology trials.
* Proven track record in managing Phase I–III global clinical studies.
* Strong knowledge of ICH-GCP, EMA/MHRA guidelines, and regulatory frameworks in Europe/UK.
* Demonstrated success in CRO/vendor management and budget oversight.
* Excellent communication, organizational, and leadership skills.
* Ability to work effectively in a remote, fast-paced biotech environment with multiple priorities.