Pediatric Clinical Trial Director (Physician)
- Brentford, England (GBR), London, ENG (GBR)
- £1000 - £1200 Per Day
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00080776
- hiv
- clinical studies
- protocol
- pediatric
- reporting
Job description
Posted 24 February 2020
Pediatric Clinical Trial Director (Physician)
GSK House, Brentford
12 Month Contract
Pay: up to £1,200 per day
Job Purpose and Key Responsibilities:
- Contribute to study protocol development
- Contribute to the development of the annex documents, including but not limited to study procedures manual (SPM), reporting and analysis plan (RAP), protocol deviation management plan (PDMP), etc.
- Contribute to the development of responses to regulatory authority’s queries regarding clinical studies
- Support the clinical scientists in the preparation of answers to local Institute Review Board (IRB)/Ethic Review Committee (ERC) questions
- Address medical issues and concerns that arise during the study feasibility assessment
- Provide medical perspective on overall study conduct, procedures and management of safety events to clinical study team
- Liaise, with the collaborator study teams, sites and/or investigators to obtain all necessary documentation to assist the Safety Review Team (SRT) and/or safety physician/scientist with establishment of medical details and causality/expectedness of SAE/death
- Liaise with external collaborators regarding conduct of their studies, e.g. regarding laboratory abnormalities of interest
Accountability:
- Evaluation of safety event reports, including SAE, adverse events (AE) and laboratory values of concern
- Escalate safety event reports in a timely manner
- Present SAE information and evaluations to the relevant safety oversight boards such as, but not limited to, SRT and VSLC
- Communicate output of safety oversight board to collaborators, sites and/or CRO, if applicable e.g. restart after liver-stopping criteria
- Provide guidance regarding protocol-related medical issues to collaborators, sites and/or CRO in a timely manner
- Provide review and approval of study protocol and risks section of ICF
- Ensure electronic protocol inquiries and site interactions, inclusive of safety events and other study-related matters are filed in the study electronic TMF (eTMF) as required
- Provide training in subject protocol-defined safety parameters and toxicity management to internal and external study team members
Specialised Knowledge:
- Physician (MD or equivalent), with clinical fellowship in Infectious Diseases and/or experience in clinical development and/or clinical trials execution in Infectious Diseases
- Significant drug development or clinical trials experience
- Expertise in HIV drug development
- Excellent leadership experience in a matrix environment
- Understanding of running clinical trial from concept study idea to publication
- Effective communication skills
- Good interpersonal relationship building/maintenance
Basic Qualifications:
- Physician (MD or equivalent-Strongly Preferred) OR Physician’s Assistant OR Nurse Practitioner with 5 plus years of experience
Preferred Qualifications:
- Clinical fellowship in Infectious Diseases
- Significant drug development or clinical trials experience
- Expertise in HIV drug development
- Demonstrated leadership experience in a matrix environment
- Understanding of running clinical trial from concept study idea to publication
- Effective communication skills
Additional information about the process
All profiles will be reviewed against the required skills and experience. Due to the high number of applications, we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply.
