Job Title: Clinical Project Manager
Location: United Kingdom
Company: Biotech
About Us:
Our client are pioneers in respiratory biotechnology, committed to improving the lives of patients with respiratory diseases through groundbreaking therapies and innovative research. As part of our continued growth, we are seeking an experienced and driven Clinical Project Manager to lead our clinical development programs and play a critical role in bringing our treatments to market.
Job Summary
The Clinical Project Manager (CPM) will be responsible for planning, executing, and managing clinical trials across all phases to ensure they are conducted in compliance with applicable regulations, timelines, and budgets. The CPM will work closely with cross-functional teams, external vendors, and investigators to deliver high-quality clinical data supporting our respiratory product pipeline.
Key Responsibilities
Project Planning & Management:
* Develop and manage detailed project plans, including timelines, budgets, and resource allocation.
* Oversee the end-to-end execution of clinical trials (Phase I–IV) in alignment with regulatory requirements (e.g., MHRA, EMA).
* Identify and mitigate project risks, ensuring timely issue resolution.
Vendor and Stakeholder Management:
* Select, manage, and oversee clinical research organizations (CROs), vendors, and external partners.
* Build and maintain strong relationships with investigators, site staff, and key stakeholders.
Regulatory Compliance & Quality Assurance:
* Ensure trials comply with Good Clinical Practice (GCP), ICH guidelines, and relevant local regulations.
* Collaborate with QA to ensure quality control and continuous improvement across all trial activities.
Budget Management:
* Monitor and control project budgets, ensuring cost efficiency without compromising quality or timelines.
* Provide accurate financial forecasts and manage change controls.
Team Collaboration:
* Lead cross-functional project teams, ensuring alignment across clinical, regulatory, and operational departments.
* Foster a culture of transparency, accountability, and collaboration within the clinical development team.
Documentation & Reporting:
* Oversee the preparation and maintenance of trial master files (TMF) and other essential documents.
* Provide regular updates and reports to senior management on project status and progress.
Qualifications and Experience
Education:
* A degree in Life Sciences, Pharmacy, or a related field (Master’s or PhD preferred).
Experience:
* A minimum of 3–5 years’ experience managing clinical trials in a biotech, pharmaceutical, or CRO setting.
* Proven track record of successfully delivering projects in respiratory or related therapeutic areas is highly desirable.
* Comprehensive knowledge of GCP, ICH guidelines, and UK/EU regulatory requirements.
Skills:
* Strong leadership, problem-solving, and decision-making abilities.
* Excellent project management skills with proficiency in project management tools (e.g., MS Project, Smartsheet).
* Exceptional communication and interpersonal skills for effective collaboration with internal and external stakeholders.
* Ability to work under pressure and adapt to a fast-paced environment.
What We Offer
* Competitive salary and bonus structure.
* Comprehensive benefits package, including private healthcare and pension contributions.
* Hybrid working model with flexibility.
* Opportunities for professional growth and career development.
* The chance to work on cutting-edge therapies that make a real impact on patients' lives.
How to Apply
If you are passionate about advancing respiratory therapies and have the expertise to manage clinical trials from concept to completion, we would love to hear from you. Please send your CV and a cover letter to alex.smith@albionryeassociates.com.