The Clinical Trial Manager is responsible for the planning, conduct and oversight of the operational portion of clinical studies and ensures studies are conducted in accordance with the protocol, SOPs, ICH-GCP and all applicable regulatory requirements. They will serve as the primary clinical point of contact with the client. They will also develop study related clinical documents, training needs for CRAs and third-party vendors, and recruitment/retention strategies.
Primarily responsible for ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member the Senior Manager is responsible for early identification and prevention of pipeline risks.
The Drug Safety Physician will be responsible for the pharmacovigilance function, including medical review and oversight of processing for all types of safety events. The individual will provide clinical support of drug safety data management and interpretation and risk management activities for the company. This includes oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation.