Description:
We are looking for a Lead Local Trial Manager (Lead LTM) who will be responsible for the local/UK management and oversight of clinical trials (or Medical Affairs data generation activity). The head office location is in High Wycombe, Buckinghamshire, and this position is home-based. We are hiring for several therapeutic areas; preferably the candidate will have experience in either Haematology, Oncology or Immunology. The Lead LTM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Lead LTM is responsible for proactively coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Lead LTM proactively leads or contributes to process improvement; training and mentoring of other LTM s and Site Managers (SM).
Key Responsibilities:
- Collaborates with Clinical Research Manager (CRM) for country protocol and site feasibility assessments, in conjunction with the local study team. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
- Collaborates with the Global and Local Project Teams to deliver for the UK.
- Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress
- Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed.
Qualifications:
Qualifications
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
Required:
- Minimum of 7 years of UK clinical trial experience is preferred, including site monitoring experience and local EC submission experience
- Should have solid understanding of the drug development process including GCP and local regulatory requirements.
- Strong leadership and communication skills.
- Proficient in speaking and writing the English language.
- Excellent written and oral communication skills Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs.
- Demonstrated ability to lead initiative/small teams.
- Ability to work on multiple trials in parallel in different disease areas, if required.