Senior Site Manager, Early Development
3 weeks ago
Location: United Kingdom
We are looking for a Senior Site Manager, Early Development & Clinical Pharmacology (ED&CP), based UK, to serve as the primary contact point between the Sponsor and the Investigational Site for the conduct of complex early development and/or clinical trials in phases 0 to 1b. In other organisations, the Site Manager may be known as Clinical Research Associate or Monitor. The head office location is in High Wycombe, Buckinghamshire, and this position is home-based. Preferably you will have experience in Haematology or Oncology.
As a Senior Site Manager, you will be responsible for maintaining ongoing inspection readiness and compliance with the clinical trial protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure. You should be flexible and be able to work independently. We are seeking to hire a strong communicator, a quick learner, a problem solver, and a real teammate. You will be responsible for oversight of clinical trial protocols at a site level and will collaborate closely with he Clinical Trial Assistant (CTA, Trial Manager (TM) and Global Trial leader (GTL).
You will work in 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 Spanish team that provides mutual support and opportunities to work together to identify new and improved ways of working.
Principal Responsibilities:
- Participates in site assessments, conducts pre-trial visits, and collaborates on investigator selection with the trial team.
- Acts as the primary contact for assigned sites for Early Development & Clinical Pharmacology (ED&CP) trials, closely working with the Trial Manager (TM) and central team for study progress and issue resolution.
- Attends investigator meetings as needed.
- Executes site initiation, monitoring, management, and close-out per internal SOPs. Implements Analytical Risk-Based Monitoring (ARBM) model. Monitors progress using study systems.
- Ensures site staff have current Good Clinical Practice (GCP), protocol, compound, and systems training. Manages training records.
- Contributes to site-level recruitment strategy and contingency planning.
- Ensures adequate trial supplies. Handles clinical drug supplies with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS).
- Ensures accurate data entry and timely query resolution.
- Ensures valid and complete data, maintaining the blind as applicable.
- Reports Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) within required timelines. Maintains accurate data and documents.
- Documents trial activities, deviations, and issues. Takes corrective actions.
- Reviews site File, ensures archiving compliance.
- Collaborates with TM to communicate site/study progress and issues.
- Attends team meetings and trainings.
- Acts as a local protocol expert, supporting multiple therapeutic areas.
- Collaborates with TM for Corrective Action Preventive Action (CAPA) and site audits.
- Prepares sites for closeout, conducts final visits.
- Manages site-specific consent forms.
- Participates in Health Authority (HA) and Independent Ethics Committee/Institutional Review Board (IEC/IRB) processes.
- Tracks site-level costs and ensures payments or collaborates with Contracts & Grants (C&G).
- Builds relationships with stakeholders and acts as site management expert.
- Coordinates site lessons learned and contributes to process improvement and training as needed.
- Coaches and mentors SMs, performs site visits.
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