We are looking for a Clinical Project Manager to lead the planning and execution of clinical programs in adherence to ICH GCP, SOPs, FDA regulations, EU CTD/CTR and any other applicable regional or local guidelines.
Responsibilities
- • Preparation, design and/or review of essential documents for regulatory, ethics and other required local/national submissions;
- • Drive the identification and selection of clinical trial investigators as per clinical operations strategy;
- • Lead/assist in development of the protocol, amendments and related GxP documents;
- • Development of SOPs, Forms, guidelines and GxP training materials;
- • Organisation and management of various trial-related meetings e.g. investigator meeting, Advisory Board, Data Monitoring Committee, Steering Committee etc;
- • Maintenance of regulatory and local clinical trials databases/registries
- • Management and oversight of Contract Research Organisation/vendor management, as required
- • Development of Case Report Forms (CRFs), CRF completion guidelines, and associated documents in collaboration with data management and biostatistics groups;
- • Creation of study manuals to facilitate study oversight and management;
- • Point of contact for all site-related issues and procedural questions;
- • Cross-functional engagement with operational teams e.g. data management, drug supply management, clinical development, biostatistics, research, regulatory and quality;
- • Set-up and maintenance of Trial Master File (TMF), ensuring audit readiness of documentation at all times
- • Ensure study certifications, insurance, licenses and registrations are maintained;
- • Attend site visits (including, but not limited to, Site Initiation Visits, study surgeries) where local and national travel policies allow;
Experience
- • Bachelor degree or equivalent degree is required, with advanced degree preferred. At least one of the degrees in life science/healthcare is preferred.
- • 8-10 years of clinical development experience of this minimum 3-5 years working as a Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO
- • Demonstrable operational capabilities in all aspects of clinical trial related activities, and proven ability to meet timelines.
- • Ability to prioritise workload in a fast-paced environment
- • Excellent communication, organization and tracking skills.
- • Proven ability to work either independently or in a team setting
- • Proven networking skills and ability to share knowledge and experience amongst colleagues.
- • Profound knowledge of ICH/GCP; comprehensive knowledge of clinical trial design methodologies and understanding of the overall drug development process.
- • Basic knowledge of relevant therapeutic areas.
- • Travel up to 30%
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Desirable
- • ATMP/GMO/Biologics handling
- • Previous monitoring experience
- • Immunology and/or hepatology experience
• Working within a small to mid-sized Biotech
Please direct any questions and CVs in the first instance to Harpreet Heir (harpreet@lifesciencepeople.co.uk) at Life Science People, our recruitment partners.
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