Senior Clinical Project Manager

Skills Alliance Enterprise; Greater London; On-site; GBP 70,000 - 110,000; Full time

Job summary

Skills Alliance Enterprise is seeking a Senior Clinical Project Manager to lead complex clinical trials across hematology/oncology and autoimmune programs. You will drive operational strategy, manage cross-functional teams, and oversee budgets, timelines, and quality targets from concept to closeout.

This role requires global collaboration, deep knowledge of ICH-GCP/FDA guidelines, and experience with outsourced projects. Travel 20-30% may be required.

Qualifications

• 10+ years in clinical research with 5+ years in project management.
• Experience in full-service outsourced projects.
• Background in hematology/oncology and/or autoimmune phase I/II studies.
• Experience with ATIMPs, site-level management and pivotal trials is an advantage.
• Experience with pediatric studies.

Responsibilities

• Lead one or more complex clinical studies from concept to closeout.
• Collaborate with CPL and Principal CPM to optimize study delivery.
• Mentor junior CPMs and CPAs where applicable.
• Drive study timelines, budgets, and quality targets.
• Coordinate country/site selection and recruitment strategies.
• Oversee data management planning and DM plan input.
• Ensure inspection readiness and eTMF oversight.
• Manage vendor selection and day-to-day oversight.
• Maintain protocol adherence and manage deviations/trends.
• Communicate effectively across cross-functional teams.

Skills

Global collaboration

Clinical Trial Execution

Project management

Budget management

Stakeholder management

Complex environments

ICH-GCP/FDA knowledge

Medical terminology

Multi-project management

Communication skills

Problem solving

MS Office

Independent working

International travel

Education

BSc in life sciences

MSc/PhD preferred

Job description

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

Demonstrated Skills and Competencies

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 pediatric 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%)