POSITION LOCATIONS: Remote based in Sub-Saharan Africa
TERMS: Contract (12months)
POSITION REPORTS TO: Clinical Project Manager
ROLE DESCRIPTION:
Guosa Life Sciences is actively recruiting for an experienced Clinical Project Manager to work as an integral part of our global study team in Sub-Saharan Africa. This role is primarily responsible for leading and managing the cross functional study team and is the single point of accountability for the operational delivery of one or more clinical studies from concept through reporting, including inspection readiness, submission and regulatory defense.
- Responsible for developing timelines and budgets for their clinical studies and leading the execution of these studies according to time, cost and quality targets.
- Develop clear and measurable project management plans and establish project metrics
- Collaborate with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
- Develop/contribute to clinical documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, study portals, electronic data capture/device management systems and other study tools.
- Assist in the submission and review of all clinical deliverables required for regulatory submissions
- Lead cross-functional teams in the timely execution of high quality clinical research projects leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with key clients, vendors, and internal team members.
- Collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs. Plan, execute and lead study-specific meetings (e.g. project management meetings, investigator meetings, steering committee meetings, etc.)
- Collect, review and approve of all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study.
- Assist project sites with IRB submissions, maintenance of regulatory documents and responding to study related questions from sites, vendors and sponsors in a timely fashion.
- Review monitoring plans and tracking and review of trip reports.
- Take on additional tasks and responsibilities, as requested.
- Collaborate with clinical operations administration to identify and oversee trial-related training and any performance concerns of team members according to their individual needs. Plan, execute and lead study-specific meetings (e.g. project management meetings, investigator meetings, steering committee meetings, etc.)
- Train, provide oversight and mentoring of clinical research assistant project manager(s) and staff assistants, as appropriate.
- Provide support to the Country Director with ad-hoc tasks as required
QUALIFICATIIONS & ATTRIBUTES:
- Bachelor’s Degree in Business, Life Sciences, Pharmacy, Nursing or related field of study and/or equivalent experience
- Minimum of three years experience working in project management related to clinical research or similar environment from either a pharmaceutical company or a CRO environment required.
- Ability to execute and manage all aspects of multi-center global clinical trials from concept to close-out within designated project budgets and timelines
- Experience across a wide range of clinical indications / therapeutic areas
- A working knowledge of drug development process, ICH-GCP guidelines and local and international regulatory requirements is essential.
- Excellent oral and written communication skills is a must
- Experience in working with global operational teams and the global delivery model across time zones / geographies
- Requires up to 10 to 30% of travel
- Fluency in written and spoken English and two other Sub-Saharan African languages
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Guosa Life Sciences HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Guosa Life Sciences may directly contact for employment application
