主要职能 Primary Function:
The Senior Clinical Trial Manager will lead, manage and coordinate the operational delivery, risk management, and overall execution of clinical trials from study start-up to close out in accordance with ICH-GCP and applicable local regulations. This role requires ensuring effective collaboration with key stakeholders and maintain consistent delivery throughout challenges and organizational changes. The SCTM will collaborate with cross-functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing, supporting clinical operations activities across one or multiple trials.
主要职责 Major Responsibilities and Duties:
• Lead and coordinate a cross-functional study team to ensure the clinical trial progress as planned.
• Drive study team collaboration and foster a culture of trust and accountability.
• Lead risk and issue management processes to proactively identify and mitigate challenges.
• Ensure quality oversight throughout all phases of the trial.
• Accountable for the overall operational delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials or regions; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements.
• Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs.
• Drafts and implements study plans including vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF(including TMF creation and QC completion).
• Supports EDC, IxRS, and CTMS systems and data maintenance.
• Accountable for the study budget including tracking timelines, milestones, and critical activities; manages assigned vendor budgets, identifies issues, and proposes resolutions.
• Drives the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale.
• Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work throughout the study implementation.
• Leads the Investigator Meeting preparation and execution with the support from cross-functional team members
• Stays current on relevant therapeutic area knowledge and clinical research best practices.
• Ensures study adherence to ICH/GCP and company SOPs.
