Senior Clinical Trial Manager – Oncology

🔥 40 minutes ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage complex Phase I, II, III, and occasionally IV clinical trials within a global clinical operations team • Provide oversight of CROs within a quality framework supporting confirmatory trials • Lead CRO and vendor selection and management • Support regulatory start-up process and study start-up planning • Manage and maintain high-performing clinical teams • Coordinate global clinical trials • Provide technical expertise for clinical documents and trial conduct, including protocols, monitoring plans, clinical trial reports, and investigator brochures • Coordinate with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management, and Regulatory teams • Manage clinical research activities of the Clinical Operations team • Estimate, track, and analyze vendor financial spend • Analyze issues involving investigational sites, CRAs, and CROs and develop action plans • Guide and manage site monitoring activities • Coordinate patient enrollment and mitigation planning • Coordinate study supplies with regulatory and clinical supplies functions • Negotiate contracts with clinical trial service vendors • Review informed consent forms, CRFs, and study materials • Plan and participate in investigator meetings • Support the data query process • Ensure investigational sites comply with sponsor SOPs and FDA and ICH guidelines • Ensure the trial master file is current and maintained

🎯 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 clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (biotechnology, pharmaceutical, CRO, or medical device) • Extensive proven experience of clinical trial management • Experience managing global clinical trials • Proven management/leadership of people in a matrixed environment • Working knowledge of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes • Ability to work independently and in a team environment • Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) • Excellent oral and written communication skills and strong organisational abilities • Willingness to travel, including internationally • Ability to work outside normal work hours when required

🏖️ Benefits

• Medical Aid Contribution • 13th Cheque • Remote/home-based work arrangement • Occasional international travel opportunities