Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight.
Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation.
Supports preparation of regulatory dossier by providing documents and required information
Leads the study start-up process, including, but not limited to, preparation of the trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process (where applicable).
Collaborates with the Clinical Trial Supply Management function to ensure an effective procurement and supply strategy for study medication, with no stockouts during trial and low overage at study end.
Oversees CRO and vendors during the trial to ensure compliance with project requirements, internal processes, timelines, budget, ICH GCP, and local and international laws.
Monitors the quality of vendor deliverables,
addresses quality issues with the appropriate team members and identifies prospects to improve training, execution and quality control.
Oversees monitoring of clinical trials, ensuring high-quality trial execution at sites, identification of deviations and implementation of mitigation strategies as required.
Ensures study is at all times inspection ready.
Provides productive updates on trial progress to Head of Clinical Operations and Senior Management.
Ensures timely shipment and tracking of lab samples to ensure no loss of samples due to lack of operational oversight and availability for timely analysis for study reporting.
Ensures risk management plans and contingency plans are available for assigned trials and escalates key study risks to the attention of the Head of Clinical Operations/Senior Management. Ensures all project-level study documentation is filed in the TMF in accordance with applicable SOPs, g