The Senior Clinical Trial Manager (SrCTM) is responsible for study team leadership in one or more cross functional study teams to deliver clinical research study deliverables on time, within budget and with good quality in compliance with Regulatory Authorities’ regulations/ICH GCP guidelines and applicable SOPs. This role collaborates and interacts with the Clinical Study Team and oversees the functional duties of the study and CRA team.

The SrCTM Will

• be responsible for the oversight of the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as applicable SOPs and policies.
• be responsible for the oversight of monitoring assigned study operational plan.
• be responsible for managing assigned as study budget, timelines, and risk mitigation
• process input from key stakeholders, communicating to the clinical team, as appropriate.
• support the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
• be responsible for the filings of all clinical trial documentation in eTMF and paper TMF as assigned.
  
  

The SrCTM Will Have

• BS degree in biology, allied health, nursing or related life science preferred.
• 7 or more years related experience in clinical study execution.
• experience leading a study or significant participation on study team through major milestones.
• experience in planning study design for pre and/or post market trials.
• experience managing others as direct supervisor and/or leader of matrix clinical trial team preferred.
• experience managing CROs and other external providers.
• system experience preferred: (i.e., CTMS, eDC, eTMF etc.).