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Role Summary: Plan, monitor, and coordinate clinical research studies at external trial sites in compliance with Good Clinical Practice, Standard Operating Procedures, and Corporate Policies, Guidelines and Standards.
Participate in selection process of external Service Providers (SPs)
Build a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks
Translate technical requirements from R&D project teams into scope of work for execution by SPs.
Build strong relationships to maximize performance and value delivered by SPs
Create a culture of joint accountability to ensure Vendor performance
Develop, maintain and share Good Vendor Management Practices
Facilitate efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences.
Facilitate final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing
Facilitate vendor training on applicable GEHC SOPs
Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs.
Performs Pre-Selection, Initiation, Monitoring, and Closeout site visits.
Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports
Collects and processes regulatory documents and correspondence.
Negotiates and tracks center/trial budget according to financial agreement with each centre
Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested
Ensures that clinical trial sites have adequate supplies to perform the trial
May supervise the work of more junior Clinical Research Associates
Masters degree in a science related field with experience with clinical trials management within the healthcare industry or BSc, with experience in monitoring clinical trials
Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results
Proven communication skills, both written and verbal, at all levels of an organization
Must be willing to travel as required
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
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