[Hiring] Senior Clinical Trial Manager @Parexel

Role Description

We are seeking a Senior Clinical Trial Manager (SCTM) to join our team in a remote capacity in South Africa. As a SCTM, 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.

Key Responsibilities

• Manage complex Phase I, II, III, and occasionally IV clinical trials as part of a global clinical operations team.
• Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials.
• Provide direction and leadership in CRO and vendor selection and management.
• Knowledge of regulatory start up process and planning in support of study start up.
• Managing and maintaining high performing clinical teams.
• Coordination of global clinical trials.
• Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
• Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
• Be responsible for and manage clinical research activity of Clinical Operations team.
• Estimate, track and critically analyze vendor financial spend on study.
• Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs.
• Provide guidance, direction, and management to site monitoring activity.
• Coordinate patient enrollment activities and mitigation planning.
• Coordinate study supplies with regulatory and clinical supplies functions.
• 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

• Extensive 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).
• Extensive proven experience of clinical trial management.
• Experience of managing global clinical trials.
• 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.
• A willingness to travel, as this position may involve occasional travel, including internationally.

Benefits

• Medical Aid Contribution.
• 13th Cheque.