Clinical Research Unit Manager - School of Medicine - Department of Pharmacology at University of Pretoria/Universiteit van Pretoria

Responsibilities

• Supervising of all clinical and administrative aspects of a clinical trial within the research unit to ensure the delivery of the required targets and quality;
• Cost control within the unit and all vendor contracts for services at the site or unit;
• Staff management, hiring, on boarding, utilization, performance management, etc;
• Setting up, conducting and successful completion of clinical trial related activities and deliverables;
• Driving and leading recruitment strategies and plans to meet study requirements and to ensure to trial participants;
• Facilitating all training (internal and external) and capacity building initiatives;
• Both Governance/compliance and quittable access on-boarding new participants to include student research Capacity building;
• Managing the total supportive process regarding the site feasibility process when being considered for a new clinical study or for contracted research or trial participation;
• Implementing of quality control methods, practices, standards, quality assurance, and quality improvements;
• Ensuring compliance with all of the applicable legislation, regulations and guidelines that govern the functioning of the unit;
• Ensuring that the site and facilities provide a safe working environment;
• Supporting the drive to elicit new business from the clinical trials industry;
• Assessing, evaluating, benchmarking, and expanding the capabilities and offerings of the CRU;
• Overseeing the CRU site activities to ensure that contracted targets and deliverables are met;
• Managing the relationship with Enterprises UP as the CRU’s business partner.

Minimum Requirements

• BCur or BPharm or MBChB (Bachelor of Medicine and Bachelor of Surgery degrees)
• A total of 6 years experience in the clinical research setting;
• Track record in the setting up, record, conduct and successful completion of clinical trial related activities and deliverables;
• Proven managerial and leadership skills within clinical research industry;
• Must have managed a profit center relevant to the pharmaceutical industry.

Required Competencies (skills, Knowledge And Behavioural Attributes)

• Advanced proficiency levels in, Regulatory and research ethics knowledge;
• Planning, conducting and overseeing of clinical trials across the entire spectrum of the drug development process, from early development study, financial and business management;
• Understanding of the global guidelines and regulations that govern the conduct of clinical trials;
• MS Office suite of products (MS Word, Excel, PP).

Added Advantages And Preferences

• Relevant postgraduate degree or equivalent;
• MBA
• A total of 2 years experience of having managed a profitable trial management business.
• Having managed a trial management business with a turnover of more than R15M per annum for at least 2 years.
• The all-inclusive remuneration package for this contract position will be commensurate with the incumbent’s level of appointment, as determined by UP policy guidelines.