Clinical Study Manager

Clinical Development Manager

Due to the continually increasing pressure on healthcare budgets, there is a growing need to deliver strong, convincing evidence to demonstrate the value (both clinically and economically) of our medicines to support positive reimbursement decisions. In response, GSK R&D has prioritised the implementation of the Real World Evidence (RWE) Programme to drive increased use of real world data to inform the development of our medicines. One of the three strategic pillars in this RWE programme is to create the capability (i.e. the infrastructure and resources required) to, efficiently and cost effectively, conduct the prospective non-interventional observational studies and pragmatic clinical trials. Once established, this will enable Integrated Evidence Teams (IETs) to utilize innovative study options to generate the data required to demonstrate the clinical and economic effectiveness of our medicines in the real world.

The VEO Study Delivery Group purpose is to

• Provide operational leadership for RW clinical trials and non-interventional studies
• Deliver an optimised study implementation framework
• Drive external capability development (operational and EHR system capability)
• Drive the policy agenda for delivery of minimally interventional trials and non-interventional studies

The CW VEO Clinical Development Manager

• Will be expected to provide operational leadership to study teams running low-risk interventional/interaction studies and non-interventional observational studies, working with 3rd party vendors to deliver high quality studies.
• May also provide support to other VEO Clinical Development Managers/Directors running complex interventional trials as required.
• Will be expected to define and create best practice for the delivery of interaction studies.
• The CW VEO Clinical Development Manager is expected to have a strong clinical research background have the overall accountability for the operational delivery of low-risk interventional/interaction studies from concept to report.

The VEO Study Manager is responsible for the following:

• Serve as the operational leader on RW non-interventional and low-risk interventional/interaction studies and RW interventional study teams with overall accountability for operational aspects of study implementation for end to end study operational excellence, from concept to publication/submission.
• study execution, tracking and management of study delivery.
• timely delivery of scientifically and operationally robust study documents.
• clinical vendor selection and contractual agreements
• site and monitor training in operational aspects of the study
• Developing and communicating best practice and innovation in low-risk interventional and non-interventional study delivery
• Working directly with Epi and VEO scientists to ensure effective planning of prospective studies and ensuring all studies conducted comply with GSK SOPs relating to human subject research.

Educational Background

• Minimum Level of Education* BA/BS or equivalent in a science or health related discipline

Job Requirements

• The role requires the incumbent to work across a number of therapeutic areas and different types of study. The incumbent will need to be in a position to understand the scientific question, quickly get up to speed with different operational challenges that may be specific to a given therapeutic area and/or study design.
• Experience in health outcomes research, patient reported outcomes, or epidemiology.
• Proven track record of leading a clinical matrix team and working with investigators, external experts, Contract Research Organizations, Local Operating Companies, and vendors
• The studies that the incumbent will have accountability for will be in the health outcomes/epidemiology arena. The incumbent will need to understand the outcomes routinely used in this type of research, study design options and bias that can be introduced depending on the study design selected and how this can impact the objective of the study.
• Demonstrated hands-on clinical operations experience preferably across a range of therapeutic areas and/or study types
• Experience in driving the development and contributing to study protocols, study procedure manuals, informed consent forms, clinical study report, and manuscripts
• Experience of vendor oversight and relationship management etc
• Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP)
• Demonstrated ability to create and foster strong strategic partnerships with colleagues that include Clinical Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Study Monitoring
• Ability to work independently and proactively
• Proven track record of applying operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
• Excellent communication skills including verbal and written communications, with the ability to present to internal department meetings and external advisory/investigator meetings.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Flexibility and willingness to take champion new approaches
• Excellent interpersonal skills
• A collaborative and partnering style.
• Good organizational and time planning skills

Role is initially home based

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