[Hiring] Clinical Trial Manager @Parexel

Role Description

We are seeking a Clinical Trial Manager (CTM) to join our team in a remote capacity in South Africa. As a CTM, you will act as a member of the sponsor’s Development Operations team and will manage individual clinical trials and/or programs as part of their Clinical Trial Working Group.

You’ll join a fast‑paced, growth‑oriented environment focused on making a meaningful impact through the set-up, execution and delivery of assigned trials and contribute to delivery of the sponsors pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites.

With diverse teams and continuous learning opportunities, the Clinical Trial Manager can explore career paths and expand skills across clinical research.

Key Responsibilities

• Manage external vendors and contract research organisations.
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual.
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents.
• Assist with protocol development and study report completion.
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols.
• Provide guidance, direction, and management to CRAs.
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities.
• Coordinate study supplies.
• Negotiate contracts with vendors of clinical trial services.
• Review Informed Consent Forms, CRFs, and study related materials.
• Plan and participate in investigator meetings.
• Assist and support data query process.
• Assure regulatory compliance of investigational sites with sponsor’s SOPs and FDA and ICH guidelines.
• Ensures trial master file is current and maintained.

Please note that responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.

Qualifications

• Experience in clinical trial project management, preferably across international trials.
• The ability to collaborate across teams and communicate clearly.
• A patient‑focused mindset and strong attention to detail.

Requirements

• Bachelor’s, nursing degree or equivalent required, science preferred.
• 5 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO).
• Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device).
• Proven experience of clinical trial management.
• Proven management/leadership of people in a matrixed environment.
• Demonstrated working knowledge of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes.
• Demonstrated ability to work independently and in a team environment.
• Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).
• Excellent oral and written communication skills and strong organisational abilities.

Benefits

• Medical Aid Contribution.
• 13th Cheque.