Project Manager - Interventional Projects at KEMRI Wellcome Trust Research Programme (KWTRP)

JOB PURPOSE: 

To plan, develop, implement and coordinate operational and administrative aspects of BOHEMIA clinical trial.

Job Dimensions:

The post holder will be responsible for planning, developing, implementing and coordinating operational and administrative aspects of the BOHEMIA project as well as support the principal investigator in research coordination, preparation, and maintenance of various scientific and research governance-related materials for the purposes of ethical and regulatory approval, GCP, and monitoring requirements.. The post is extremely demanding and involves a high level of diplomacy with regards to effective communication among a multi-disciplinary team, study participants, departmental managers, regulatory bodies and the wider community. The post holder will need to be experienced and highly self-sufficient to manage a complex programme of research work.

This post is based at the KWTRP with frequent travel to Kwale. KWTRP is a partnership between the Kenya Medical Research Institute, the Wellcome Trust and the University of Oxford, and a world-renowned health research unit. The KWTRP works together with scientists, health services and local communities to achieve better health, while also developing local scientific leadership and infrastructure.

Reports to:

• Head of Clinical Trials Facility/Principal Investigator

Direct Reports: 

• Data Manager
• Research Medical Officer
• Pharmacist, Archivist

Financial Responsibility: 

• The position is responsible for oversight of research grant budget and project assets

Key Responsibilities:

• Ensure effective project plans are in place and operational for each work package and work proactively with the team to set priorities in accordance with applicable project plans, standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements; and maintain a register of risks and implement strategies to mitigate risk in collaboration with the QA manager.
• Establish systems to track trial progress, milestones and performance metrics.
• Provide efficient updates on trial progress to the PI, with respect to project plans, trial budget and timeline management, recruitment, inventory management, and trial conduct.
• Oversee organizational structures, work schedules, task management and project milestones; be responsible for analysis, monitoring and evaluations of targets and strategic objectives; identify potential delays, bottlenecks and their effects on project deliverables; and implement strategies to ensure operational effectiveness.
• Lead study planning and start-up process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF) and study planning meetings.
• Contribute to strategic planning and oversight of capital, operating budgets and expenditures for research grants and future grant applications in liaison with the finance and grants departments at KWTRP and the University of Oxford.
• Responsibility for ethics and regulatory document preparation and submissions, timely report submissions and communication with ethics and regulatory bodies.
• Develop or supervise development of Standard Operating Procedures (SOPs) for the projects together with the study team and conduct training/supervise training on SOPs/SIVs and ensure that clinical teams fulfil their roles and responsibilities.
• Responsibility for maintenance of study records and documents, their secure storage, and ensuring all data are filled out appropriately and documents are up to date.
• Coordinate monitoring and audit visits and ensure that all requirements are met including availability of documentation and relevant staff.
• Liaise with the KWTRP Community Liaison Group to develop and implement site and community engagement strategies.
• Represent the research project to relevant internal committees, external organizations and, where appropriate, funding agencies.
• Participate in scientific and business meetings within the Clinical Trials Facility when required.
• Undertake other duties as assigned.

Qualifications:

• A Masters in life sciences or equivalent from an accredited institution.
• A degree in nursing or life sciences, diploma in clinical medicine, or a Registered Nurse
• At least 5 years’ experience in clinical trials, including 3 years’ experience that is directly related to the duties and responsibilities specified above.

Essential competencies:

• Exceptional project management skills, proficiency in using project management tools and the ability to manage multiple large projects simultaneously.
• Significant skill in leadership, organization, prioritisation, problem solving and decision making.
• Financially literate with sound knowledge of budgeting methodologies and resource management concepts including proven experience of preparing and monitoring budgets and financial reports
• Demonstrable experience in writing high quality reports and presentations in English, with evidence of being attentive to detail.
• Ability to network, communicate, be diplomatic and maintain strong local and international relationships within a multi-cultural environment and wide diversity of people, and have experience in resolving disputes.
• Knowledge of regulatory requirements and best practices in clinical trials
• Strong leadership, organisational and planning ability, with an ethical standpoint
• Strong interpersonal and communication skills (oral and written)
• Training in GCP and research ethics

Desirable:

• Training in Project Management or equivalent from an accredited institution

Physical Environment/Conditions:

• Based at the KEMRI-Wellcome Trust Research Programme in Kenya.
• Some travel to study sites.
• Be available to work out of hours if necessary.

The application closing date is 30 March, 2023.