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Form of workJob Description
Our client is seeking a Clinical Trial Manager to join their team!
Position Summary
Join their dynamic Clinical Operations team as a Clinical Trial Manager (CTM), responsible for the comprehensive management of Clinical Trials, vendors, and Clinical Trial sites. In this pivotal role, you will oversee day-to-day operations of vitro diagnostics (IVDs) clinical studies and related projects. Your expertise ensures strict compliance with SOPs, ICH/GCP guidelines, and regulatory requirements. Collaborating with cross-functional teams, you'll align trials with company goals, timelines, and budgets while building strong relationships with clinical sites, vendors, investigators, and stakeholders to drive successful clinical research outcomes.
Responsibilities
- Collaborate with cross-functional teams to support study execution, focusing on Clinical Operations deliverables aligned with study objectives.
- Oversee all aspects of Clinical Trials, including vendor management (CRO & Central Laboratory oversight and other service providers), for efficient study operations.
- Accurately track and report study metrics and timelines to leadership to achieve study milestones.
- Ensure adherence to ICH GCP, regulatory guidelines, study protocols, and company-specific SOPs for Clinical Trials.
- Assist in preparing and reviewing critical Clinical Trial documents, including protocols, informed consents, Clinical Monitoring Plans, Project Plans, Case Report Forms, and Clinical Study Reports.
- Effectively triage questions from vendors and clinical sites to provide prompt responses and solutions.
- Organize and lead cross-functional study team meetings, delegating when necessary, and liaise with various departments for streamlined clinical study oversight.
- Establish and maintain the Trial Master File (TMF) throughout the trial, conducting periodic reviews for completeness and accuracy.
- Participate in and coordinate the resolution of audit findings, maintaining an audit-ready condition of Clinical Trial documentation, including central clinical files.
Qualifications
- Education: Bachelor's degree (or higher) in a science or health-related discipline.
- Experience: A minimum of 5 years of relevant clinical development experience in a sponsor (Pharmaceutical or Biotech) or CRO role, including at least 1 year in a clinical study management role, or an equivalent combination of education and experience.
- Clinical Trial Expertise: Demonstrated experience in the development, implementation, management, and successful completion of multiple major Clinical Trials. Ability to contribute to the preparation of clinical development plans, Clinical Trial design, protocol writing, and essential documents.
- Laboratory & IVD Practices: Experience managing IVD Clinical Trials with familiarity with Good Clinical Laboratory Practices (GCLPs) is preferred.
- Regulatory Knowledge: Strong understanding of Good Clinical Practices (GCPs), International Conference on Harmonisation (ICH) guidelines, and a comprehensive knowledge of regulatory requirements.
- Communication Skills: Exceptional written and verbal communication skills, with the ability to deliver clear instructions and guidance to teams within the organization and influence stakeholders at higher levels.
- Problem-Solving: Demonstrated problem-solving skills to address challenges effectively.
- Travel: Ability and willingness to travel approximately 10%-15% of the time.
Our client acknowledges that equal opportunity for all persons is a fundamental human
value. Each employee and applicant will be considered on the basis of individual ability and merit, without regard to race, color, religion, age, sex, sexual orientation, gender identity, gender expression, pregnancy, national origin, marital status, physical disability, mental disability, medical condition, genetic information, protected military or veteran status, or any other characteristics.
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