Permanent Clinical Team Leader - Field Based
Major CRO Based Berkshire
Excellent Salary and Benefits
My client is a leading CRO which specialises in providing a full range of phase I to IV clinical development services across six continents. My client is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to my client for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials.
The Clinical Team Leader serves as the Lead CRA (LCRA) with full responsibilities for clinical monitoring and line management of Clinical Research Associates (CRAs). They ensure appropriate communication, regulatory documentation, and ongoing oversight of projects and provide support for business development.
Essential Skills & Qualification
Keeps project leadership apprised of team issues, seeking guidance as needed.
Maintains timely and effective communication among team members and site staff. Attends Kick-Off, Quick Start, and Investigator meetings
Independently resolves protocol questions with the Project Manager (PM) and patient related issues with the Medical Monitor
Maintains a record of all contacts with the PM or MM concerning protocol deviations and clarifications.
Monitoring and Oversight
Reviews the study scope of work, budget, and protocol content. Provides training to project teams on protocol, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study
Leads weekly project calls with CRAs.
Responsible for site assignments for CRAs.
Ensures study specific training requirements are completed and documented.
Provides assistance and/or^co-monitoring with regional team for high enrolling or problematic sites.
Collaborates with internal project team members to assure timely site initiation process. Facilitates the site selection process utilizing Quick Start methods and appropriate feasibility assessments, if applicable.
Assists the PM with tracking site initiation status, including Institutional Review Board (IRB) approvals and scheduling of site initiation visits to coincide with shipment of clinical supplies.
Reviews site visit reports according to Company or Sponsor requirements. Reviews Clinical Trial Management System to provide oversight and to ensure timely entry of all operational aspects (required visits, duration, and frequency) according to contracted project scope.
Requests clarifications and corrections to the visit reports, follow-up letters, and other site correspondence.
May serve as subject matter expert on implementing study specific factors into the trip report.
Reviews system reports to^track CRF collection/entry and quality.
Assists with clinical listing reviews.
Prepares and presents materials for bid defence meetings.
May be responsible for the supervision and administrative oversight^of direct reports, which are most commonly CRAs.
Develops training plan and assures training compliance for all direct reports.
Evaluates strengths/developmental opportunities of staff members.
Sets clear goals and objectives for all direct^reports.
Completes performance reviews and implements performance plans.
Ensures CRA metrics are met. Meets regularly with direct reports to mentor them and to evaluate workload and metric compliance.
Provides data for the maintenance of resourcing tools.
Collaborates with study leadership/management to identify project resourcing demands, resolving potential resourcing conflicts and facilitating mutually beneficial resolutions.
Provides feedback to management on areas for process improvements and may participate in process improvement teams.
Participates in interviewing, collaborates with HR/Training in assessing initial training needs, and orientates new hires into the team and function.
Facilitates teamwork; influences and motivates team to accomplish goals by encouraging direct and open communication, resolving conflict, and demonstrating support to team members.
Ensures required on-site CRA assessment, sign-off, and documentation occurs.
Degree educated in the science/health care field or nursing degree, or equivalent
Independent field monitoring experience
Lead monitoring or comparable supervisory experience
Ability to travel up to 50% of the time
Ability to handle multiple tasks to meet deadlines in a dynamic environment
Software Competence: MS Office, MS Project, Zinc, INFORM or RAVE, IMPACT, DOCUMENTUM
Valid Driving License: Essential
Working Language(s): English
Requirement for Business Travel: Yes