Clinical Trial Manager

Job Summary: The Clinical Trial Manager plays a crucial role in the planning, execution, and monitoring of clinical trials conducted by our organization to ensure compliance with regulatory standards, adherence to study protocols, and timely delivery of high-quality data. The CTM will maintain effective communication with study sites, investigators, and other stakeholders. The CTM will be responsible for coordinating and conducting trial monitoring activities, tracking study progress, and ensuring data integrity throughout the clinical trial lifecycle. The CTM will collaborate closely with cross-functional teams, including clinical operations, medical affairs, regulatory affairs, and data management to drive successful trial outcomes

Primary Responsibilities

Study Monitoring

• Monitor study progress, including data collection, safety reporting, and protocol adherence, and identify and resolve any issues or deviations.     
• Monitor trial progress and performance metrics, identifying and addressing issues proactively to ensure timely completion and data quality.
• Manage study documentation, including maintaining the trial master file and ensuring completeness and accuracy of essential documents.  
• Coordinate and oversee site initiation activities, including investigator meetings, training sessions, and study start-up activities.
• Conduct feasibility assessments to evaluate potential clinical trial sites and provide recommendations for site selection.
• Conduct on-site visits to assess site performance, data quality, and protocol compliance.
• Provide regular updates on trial progress, milestones, and key issues to stakeholders, including senior management.

Trial Planning and Oversight:

• Manage external clinical sites including: site initiation, assessment training, essential document collection, study recruitment and enrollment, device allocation, etc.
• Collaborate with cross-functional teams to develop clinical trial protocols, including study objectives, design, endpoints, and eligibility criteria.
• Contribute to the development of trial budgets, timelines, essential study plans (Clinical Monitoring Plan, Safety Management Plan, etc.), informed consent forms, EDC guidance docs, etc.
• Identify and mitigate potential risks and challenges in trial planning and execution.
• Liaison between the clinical sites, Sponsor, and internal teams to ensure study is conducted per protocol, GCP, and internal SOP standards.

Data Management and Analysis:

• Collaborate with data management teams to ensure accurate and timely collection, review, and analysis of clinical trial data.
• Participate in data review meetings and contribute to data interpretation and reporting activities.
• Ensure data integrity and confidentiality throughout the trial lifecycle.

Regulatory Compliance:

• Ensure compliance with relevant regulatory requirements, including FDA regulations, ICH guidelines, and local regulatory standards.
• Prepare and submit regulatory documents, such as Investigational New Drug (IND) applications, Institutional Review Board (IRB) submissions, and Clinical Trial Applications (CTAs).

Knowledge, Qualifications, and Skills

• 5+ years of experience in clinical trial management, preferably in the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial regulations, guidelines, and standards (e.g., FDA regulations, ICH GCP).
• Experience managing Phase I-IV clinical trials across multiple therapeutic areas.
• Excellent project management skills, including the ability to prioritize tasks, manage timelines, and mitigate risks.
• Strong leadership and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS).
• Certification in clinical research (e.g., CCRA, CCRP) is a plus.