Single-Sponsor Study Start Up Manager / Clinical Operations Manager – South Africa
Permanent, Full Time Contract
Clintec (an IQVIA company) is actively recruiting for a Study Start Up Manager/Clinical Operations Manager to join our expanding global company in South Africa. This is a permanent, full time, part home based and part office based role in the Johannesburg area.
The successful candidate will work fully assigned to one of our sponsors, a top 5 pharmaceutical company. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
Role Description
The Clinical Operations Manager will be accountable for the execution and oversight of local operational clinical trial activities in Country. The COM will also be responsible for local regulatory and financial compliance for assigned protocols.
Responsibilities of the Clinical Operations Manager (FSP):
Take ownership of country and site budgets
Develop, negotiate and complete of Clinical Trial Research Agreements (CTRA)
Oversee and track clinical research-related payments
Perform reconciliation of payments at study close-out
Track financial forecasting of the operational budget in conjunction with Clinical Research Director
Execute and oversee the clinical trial country submissions and approvals for assigned protocols
Develop local language materials including local language Informed Consents and translations
Manage country deliverables, timelines and results for assigned protocols to meet country commitments
Collaborate closely with Regional Operations to align country timelines for assigned protocols
Provide support and oversight to local vendors as applicable
Oversee and coordinate local processes
Manage supplies, drug supplies and supplies destruction, importation and exportation requirement, archiving and retention requirements, and insurance process
Maintain country information in clinical, regulatory, safety and finance systems
Essential Criteria:
Educated to Bachelor's Degree (or comparable) in Business Finance, Administration, Life Science or equivalent Health Care related experience
5-7 years’ clinical research experience
Extensive experience in clinical project management and coordination
Expertise of core clinical, regulatory and financial systems, tools and metrics
Extensive knowledge of local regulatory environment and submission and approval processes
Strong communication and leadership skills
Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal
The ability to focus on multiple deliverables and protocols simultaneously is essential
Ability to work effectively also in a remote virtual environment with a wide range of people
Fluency in English and a local South African language
Ability to work part home and part office based in the JHB area
