Our Careers

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%

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.