Head of Governance and Research Support Services – Gambia Full Time

Overall Purpose of the Job:

The MRC Gambia is seeking to recruit a Research Governance & Support Services Manager to manage the internal departments/offices, namely Clinical Trials; Data Management & Archives; Bioinformatics & Statistics; and Research Development & Project Management.

The post-holder will develop a detailed understanding and provide guidance to the Unit and the wider clinical research community on the implications for clinical research of specific regulations and guidance such as the clinical trials regulations, Data Protection Act and the Research Governance Framework and the regulatory aspects of clinical trials. They will develop, generate and encourage a wide range of external funding opportunities and collaborations.

Principal Duties and Responsibilities

Research activities

• Develop, establish and deliver a portfolio of high-quality clinical trials through close collaboration with MRC researchers and their national and international partners to enhance the reputation of MRC Gambia as a centre of excellence for delivering clinical trials.
• Develop, implement and manage a robust system of quality assurance for all clinical trials.
• Develop and establish, in consultation with the Quality Manager, quality management systems and processes to ensure that clinical trials are run in accordance with Good Clinical Practice (GCP) and MRC policies & procedures to ensure compliance with the Research Governance Framework.
• Lead the review and development of MRC policies and procedures for governance, cost and risk implications to provide the best possible support to internal and external investigators to ensure continued quality improvement.
• Provide support for Independent Committees for data monitoring, audits and inspection of clinical trials and ensure that their recommendations are effectively communicated and implemented.
• Ensure all clinical trials documentation is held in accordance with the Data Protection legislation and resources and systems are in place to allow appropriate data collection and analysis.
• Oversee the management of Data Management & Archives, Bioinformatics & Statistics and Research Development & Project Management to ensure it provides high quality support for clinical trials and other research activities at the Unit.
• Will work closely with Scientists from the 3 Research Themes.
• Will interact externally with clinical collaborators and will provide support to external collaborators and site personnel to ensure compliance with applicable regulations and policies.

Training

• Provide advice and training in clinical trials, research governance, regulatory approval and project management to MRC staff and visiting workers.
• Contribute to the training and supervision of scientists and research students, including PhD students.
• Recruit, train, manage, appraise and develop the Unit’s staff, delegating responsibility as appropriate to ensure that staff are well trained and motivated to provide high quality support to researchers.

Finance

• Develop, in conjunction with the Director of Operations and the Head of Finance, a financial plan for the sustainability of the Clinical Trials Department, exploring ways to promote efficiency and cost effectiveness and improve value for money.
• Assist with costing new trials, help to develop grant applications and oversee the management of clinical trial grants.
• Assist with the development of a standardised costing model for clinical trials.
• Manage and review budgets for the department in close liaison with the Finance Department and the Research Support Office.

Other

• Be a member of MRC Unit The Gambia’s Scientific Coordinating Committee, which is responsible for evaluating all proposals in terms of their scientific merit and relevance to the Unit’s research mission.
• Represent the Unit at Government and other stakeholder meetings.
• Undertake all work following the relevant safety rules and regulations as laid down in the MRC Safety Manual.

PERSON SPECIFICATION

Qualifications, Knowledge & Experience

• Postgraduate degree or professional qualification
• Formal training in ICH-GCP
• Expert knowledge of clinical trial methodology and regulatory requirements.
• Substantial experience in the design, conduct, analysis and reporting of clinical trials.
• Experience of collaborating with and managing multi-disciplinary project teams.
• Experience of advising and influencing others at senior level.
• Experience of budgetary control and reporting.
• Established organizational skills and ability to oversee a number of projects.
• Methodical, practical with excellent attention to detail.
• Able to maintain good judgement under pressure and meet deadlines.
• Computer literate.

Problem solving & initiative

• Innovative, able to problem solve and be decisive.
• Proven ability to successfully negotiate clinical trials regulations.

Management & Teamwork

• Excellent demonstrable management and leadership skills.
• Ability to identify priorities.
• Ability to delegate.
• To be able to work both independently and collaboratively with medical, scientific and technical staff

Communicating & Influencing

• Writing skills for drafting protocols, reports, funding applications and regulatory documents.

Other skills & Behaviours

• Ability to work co-operatively with key stakeholders including The Gambia Government
• Health Services
• Ability to think strategically, for example in developing the portfolio of clinical trials to be undertaken at the Unit.
• Ability to work co-operatively in a team

Tagged as: The Gambia