Local Trial Manager
Location: Gauteng, South Africa
Contract: Permanent
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist Local Trial Manager, located South Africa, supporting the Neuroscience, Oncology, Infectious Disease & Vaccines, Pulmonary Hypertension and Immunology Therapeutic Areas.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.
The Local Trial Manager (LTM II) is responsible for local management of a clinical trial in a country or multiple countries in Africa. The LTM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The role is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are aligned with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The LTM II will also have site management responsibilities, which include and is not limited to; performing site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The LTM II will be expected to travel to trial sites, as applicable.
Key Responsibilities:
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