Site Manager, Early Development

3 weeks ago

High Wycombe, Buckinghamshire, United Kingdom Johnson & Johnson Full time
Site Manager, Early Development & Clinical Pharmacology

Location: UK

We are looking for a Site Manager in Early Development & Clinical Pharmacology (ED&CP) to serve as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. The head office location is in High Wycombe, Buckinghamshire, and this position is home-based. Preferably you will have experience in Phase 1 Haematology but other therapeutic areas are considered. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. You will partner with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.

You will be part of a hardworking, enthusiastic, and committed study team eager to deliver and help improve the lives of millions of patients. You will also be part of a wider local UK team that provides support and opportunities to work together to identify new and improved ways of working.

Principal Responsibilities:
  • Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
  • Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
  • Attends/participates in investigator meetings as needed.
  • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
  • Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.
  • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
  • In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.
  • Ensures full documentation of trial related activities in all study files; communicates site and study progress and issues to the Local Trials manager and central study teams.
  • Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments.
  • Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology
  • May participate to process improvement and training.

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