Skills Alliance Enterprise
Senior Clinical Project Manager
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Senior Clinical Project Manager
12-month contract
Remote | London, UK
May require time in office 1-2x's/month
As needed travel across global sites
£ 110-125/hr - Inside IR35
About our Client:
Our client is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defense mechanisms, and eliminate these cells. They have a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumours, and autoimmune diseases.
Role Summary:
The Senior Clinical Project Manager (Sr. CPM) is responsible for the operational management and execution of clinical trials, ensuring delivery of study milestones with high quality, timeline adherence, and budget compliance. This role implements quality by design principles throughout study execution, coordinates cross-functional teams, and manages CRO/vendor relationships. The Sr. CPM contributes to risk management and operational decision-making to support successful study delivery.
Key Responsibilities:
- Autonomously leads one or more complex / pivotal clinical studies, providing leadership, operational strategy and direction to cross-functional clinical study team members (in-house and outsourced) from concept to closeout
- Works closely with the Clinical Programme Lead (CPL) and Principal CPM to implement operational strategies for optimal study delivery
- May provide mentorship to junior CPMs and Clinical Project Associates (CPAs)
- Contributes to optimization of Clinical Operations processes and continuous improvement activities
- Manages study timelines, budgets, and quality targets, ensuring effective tracking and forecasting
- Collaborates with Site Management and Engagement on country/site selection and recruitment strategies
- Works with Product Delivery to coordinate clinical supply requirements
- Leads cross-functional risk-based quality management approaches, ensuring appropriate risk identification and mitigation strategy development
- Reviews safety and efficacy endpoints and supports implementation of effective tools and training
- Manages and tracks the Clinical Trial Budget
- Coordinates study team communications to facilitate effective cross-functional collaboration
- Supports vendor selection and provides day-to-day vendor management
- Oversees protocol compliance, ensures protocol deviations are tracked/assessed, trends identified, and adjustments made to operations and/or protocol
- Reviews and approves monitoring visit reports, identifying and addressing reported issues/trends
- Drives inspection readiness activities, providing oversight of electronic Trial Master File (eTMF) to maintain inspection-ready status
- Collaborates in Data Management Plan development; Inputs on CRF/eCRF design; Reviews edit check specifications; Inputs on data review strategy and collaborates with DM to monitor data quality metrics
- Manages data cleaning activities and supports database lock timelines
- Develops study-specific training plan for the clinical study team members and ensures documentation of training in eTMF
- Provides operational input to protocol development
- Maintain and enhance knowledge in Haem/Onc and/or Autoimmune
- Develop and maintain project plans and documents following ICH-GCP and company SOPs.
- Responsible for adhering to all health and safety guidance provided by the Company
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Demonstrated Skills and Competencies
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E – Essential
P – Preferred
Experience:
- 10 years+ clinical research experience, including 5 years+ in clinical project management (or equivalent) roles (E)
- Experience in managing full-service out-sourced projects (E)
- Experience in hematology/oncology and/or autoimmune phase I/II studies (E)
- Experience with ATIMPs, site-level management and managing pivotal trials an advantage. (P)
- Experience with paediatric studies. (P)
Qualifications:
- Relevant life science first degree (BSc or equivalent) (E)
- Higher degree an advantage MSc/PhD (P)
Skills/Specialist Knowledge:
- Adept at working in a global setting and matrix environment (E)
- Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, data management experience, clinical leadership expertise)
- Demonstrated project management/leadership experience
- Experience in understanding of key drivers impacting budgets and managing project to budget
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers (E)
- Ability to manage in complex and challenging environments
- Thorough knowledge of ICH-GCP guidelines and FDA regulations (E)
- Knowledge of medical terminology and clinical patient management (E)
- Ability to manage multiple projects (E)
- Excellent communication, interpersonal and organisational skills (E)
- Highly effective problem solving skills (E)
- Computer literacy, proficiency in Microsoft Office (E)
- Ability to work independently and to effectively prioritize tasks (E)
- Ability to travel internationally (20-30%)
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