JOB PURPOSE:
This role is responsible for planning, developing, implementing and coordinating technical, operational and administrative aspects of the RVF003 clinical trial of a Rift Valley Fever vaccine and ensure compliance with the protocol, ethics and regulatory guidelines and in accordance with ICH GCP. To work closely with the PI, other internal and external stakeholders to ensure the trial is delivered within time, budget and scope. The post holder will need to be self-sufficient and be able to work with minimal supervision in a demanding environment, often with unpredictable timelines. The post is mentally demanding and extremely good communication is essential. The post holder may also be required to contribute to other associated projects.
Description:
REPORTS TO: Principal Investigator
DIRECTLY SUPERVISES: Study Coordinator
INDIRECTLY SUPERVISES: None.
BUDGET AND RESOURCE RESPONSIBILITY:
Managing study imprest and work closely with the PI in developing budgets.
Approval of requests on the financial management system (FMS).
JOB DIMENSIONS:
KEY RESPONSIBILITIES:
Ensure effective project plans are in place and operational for the trial and work proactively with the trial team to set priorities accordingly.
Maintain register of risks and implement strategies to mitigate risk in collaboration with relevant teams.
Oversee organizational structures, work schedules, task management and project milestones and implement strategies to ensure operational effectiveness.
Lead study planning and start-up process.
Develop Standard Operating Procedures (SOPs) for the project together with the study team and conduct training/supervise training on SOPs/SIVs.
Lead community engagement activities, liaise with the community liaison group (CLG) to develop strategies for trial recruitment.
Establish and update systems to track trial progress, milestones and performance metrics.
Coordinate monitoring and audit visits and ensure that all requirements are met.
Maintain study records and documents, their secure storage, and ensure all data are filled out appropriately and documents are up to date.
Create job descriptions and staff requisition forms for job advertisements for projects, conduct interviews and selection.
Contribute to strategic planning and oversight of capital, operating budgets and expenditures for research grants and future grant applications in liaison with all relevant stakeholders.
Prepare and review routine reports to funders, relevant stakeholders.
Prepare ethics and regulatory documents and submissions, ensure timely report submissions and communicate with ethics and regulatory bodies.
Supervise clinical trial coordinators to develop, track and report work schedules, task management and milestones and ensure alignment of activities with project priorities.
Manage leave for project staff and ensure leave taken is as per the Programme policy
Determine communication needs, plan and assess communication strategies and media interaction for the project and liaise with Communications teams.
Organise key trial meetings, including DSMB to discuss trial progress.
QUALIFICATIONS:
Bachelor of Science degree in relevant biological research field. Master’s an added advantage.
Minimum 5 Years’ management experience with 3 Years’ experience in managing and coordinating research projects; management of clinical trials an added advantage
DESIRABLE CRITERIA:
Project Management Certification
Good knowledge of project management framework best practices as defined under PRINCE2 or PMP and ability to implement a project successfully.
Financially literate with sound knowledge of budgeting methodologies and resource management concepts including preparing and monitoring budgets and financial reports.
Ability to communicate effectively to a high standard, including relatively complex scientific matters, orally and in writing
Knowledge of ethical and regulatory requirements and best practices in clinical trials.
COMPETENCIES:
Unquestionable integrity
Excellent interpersonal, written, presentation and communication skills
Good analytical, problem solving and critical thinking skills
Ability to work as part of a team in a multi-cultural environment
Strong flexibility, adaptability and attention to detail
Strong team coordination and supervisory skills.
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