Sr. Clinical Trial Manager

Sr. Clinical Trial Manager Job Description Template

Our company is looking for a Sr. Clinical Trial Manager to join our team.

Responsibilities:

  • Ensure audit-ready condition of clinical trial documentation including trial master file;
  • May serve as subject matter expert (SME) in one or more areas such as systems, tools, best in class standards for operational execution, etc;
  • Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs;
  • Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $100M;
  • Plan, execute, and lead study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.);
  • Co-lead development of clinical study synopsis and protocols in conjunction with the clinical development plan;
  • Develop and manages comprehensive study timelines and metrics;
  • Coordinate and assist in the planning of regulatory or ethics committee activities for clinical studies, as appropriate;
  • Assist with the writing and development of SOPs as required to ensure compliance with regulations and local laws;
  • Manage assigned global clinical studies encompassing all aspects from start-up through close-out (reconciliation of Trial Master File);
  • Proactively identify and resolve issues, escalate as appropriate;
  • Participate in the planning of quality assurance activities and coordinate resolution of audit findings;
  • Works cross functionally to develop internal work processes and procedures;
  • Responsible for the selection, training, and management of study personnel (contract and internal) to ensure efficient operation of the function.

Requirements:

  • Must be able to travel up to 25%
  • At least 6 years of direct clinical trial management experience in the biotech/pharmaceutical industry;
  • Must have multi-trial, Phase 2/3, global experience as a lead study manager;
  • Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections;
  • Excellent oral and written communication skills;
  • Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management;
  • Strong management skills and ability to effectively lead and collaborate with both internal and external stakeholders;
  • Demonstrated leadership, problem solving, conflict resolution, and team building skills;
  • Bachelor’s Degree in science or a health-related field required; advanced degree preferred.