Are you a skilled and experienced project manager with a passion for making a difference in clinical research? The Foundation for Professional Development (FPD) is offering an exciting opportunity for a dedicated professional to join our Research Department as a Project Manager – Clinical Trials at our Ndevana Community Research Site in the Eastern Cape.
Project Manager Job Overview
- Job Title: Project Manager – Clinical Trials
- Location: FPD Ndevana Community Research Site, Eastern Cape
- Department: Research Department
- Reporting to: Clinical Lead / Principal Investigator
- Annual Salary Range: R470,840 – R533,465
- Closing Date for Applications: 30 August 2024 at 16h00
Purpose of the Project Manager Position
The Foundation for Professional Development (FPD) is seeking a dedicated and experienced Project Manager to join the Research Department at the Ndevana Community Research Site in the Eastern Cape. The Project Manager will play a pivotal role in the comprehensive management of clinical trials, ensuring that all study-related activities are conducted efficiently and in strict compliance with protocols, regulatory requirements, and standard operating procedures (SOPs).
This role involves day-to-day oversight of study administration, data collection, staff training, regulatory submissions, and stakeholder engagement to ensure the successful completion of projects.
Responsibilities
As a Project Manager in Clinical Trials, your responsibilities will include:
1. Study Administration and Coordination
- Oversee the daily management of study-related activities, ensuring smooth operations and effective engagement with people involved in the trials.
- Compile and analyze study reports, liaising with key stakeholders in conjunction with clinic management.
- Ensure efficient participant flow through the clinic, troubleshooting any clinic flow blockages in collaboration with healthcare staff.
- Manage nursing staff and provide support to the Community Liaison Coordinator.
- Ensure compliance with Good Clinical Practice (GCP) and study protocols.
2. Data Management and Quality Control
- Ensure the complete and accurate collection of data for all studies.
- Conduct quality checks for Informed Consent Forms (ICFs).
- Oversee the quality control (QC) of all study-related source documents.
3. Training and Compliance
- Conduct or arrange relevant study-related training for staff, ensuring they are appropriately trained, and study protocols are strictly followed.
- Implement research protocols and maintain compliance with protocols, SOPs, and study procedures.
- Maintain and update the Investigator Site File and regulatory indexes.
4. Regulatory and Documentation Management
- Prepare and submit regulatory submissions, following up on responses and approvals with regulatory agencies.
- Handle relevant submissions to the Ethics Committee.
- Assist in managing the progress of studies by monitoring regulatory submissions and approvals.
- Maintain and update the Investigator Site File, ensuring studies are renewed or recertified as required.
5. Stakeholder Engagement
- Attend international and national conference calls, study meetings, and engage with funders and stakeholders under the direction of the Principal Investigator (PI).
- Contribute to managing the research site and maintaining relationships with site stakeholders.
- Collaborate in compiling reports for funders, sponsors, or other relevant oversight bodies.
6. Administrative Support
- Compile and submit study progress reports and other study-related documentation in conjunction with the PI and Site Manager.
Requirements
To be considered for the Project Manager – Clinical Trials position, candidates should possess the following qualifications and experience:
Educational Qualifications:
- Bachelor of Science Degree or equivalent is required.
- A Project Management qualification is essential.
- A Post-graduate qualification in Public Health is advantageous.
- A valid Good Clinical Practice (GCP) certificate is advantageous.
Experience and Knowledge:
- Minimum of 5 years of experience in clinical trial coordination or a similar role, including experience as a Study Coordinator in a research environment.
- At least 2 years of demonstrated experience in people management.
- Strong knowledge of quality control activities, systems, and processes (QA/QC), including drafting Standard Operating Procedures (SOPs).
- Deep understanding of regulatory requirements and guidelines.
- Experience in stakeholder management, including local and international collaborators.
- Experience in data collection and the management of project documentation.
- Knowledge of Good Clinical Practice (GCP).
- Knowledge of HIV and adherence issues.
- Experience with SAHPRA, HREC, and other regulatory submissions.
- Proficiency in electronic data capture systems (e.g., MediData, RedCap).
Additional Requirements:
- Proficiency in reading, speaking, and writing English.
- Proficiency in another local language is advantageous.
- Report writing and business writing proficiency.
- Proficiency in Microsoft Office (Teams, Outlook, Word, Excel, PowerPoint).
- A valid code 08 driver’s license and a willingness to travel.
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How to Apply
Interested candidates should forward the following documents to recruitment@foundation.co.za:
- Motivational letter
- CV
- Subject line: Clear indication of the position you are applying for (Project Manager – Clinical Trials)
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The Foundation for Professional Development fosters a diverse and inclusive workplace. We invite and encourage qualified candidates with disabilities to apply for positions within our organization.
For enquiries, please contact Leah Maenetja at leahm@foundation.co.za.
Please note: Only applicants shortlisted for assessments and/or interviews will be contacted. If you have not been contacted within one month after the closing date of this advertisement, please accept that your application was unsuccessful.
This is more than just a job; it’s an opportunity to lead and shape the future of clinical trials in a meaningful way. By joining the FPD as a Project Manager – Clinical Trials, you will be at the forefront of research that can change lives, while ensuring the highest standards of quality and compliance.
