Clinical Trial Manager

About the role

The Clinical Trial Manager (CTM) 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.

Responsibilities

• Oversee 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, ensuring compliance with all relevant regulations including GCP, ICH, and Regulatory requirements, as well as applicable SOPs and policies.
• Manage the assigned study operational plan, including monitoring activities.
• Manage assigned study budget, timelines, and risk mitigation processes, incorporating input from key stakeholders and communicating updates to the clinical team as appropriate.
• Support the development and application of standardized operational study processes, methodologies, quality and performance metrics, and tools to systematize continuous process improvement and best practices across clinical operations.
• Ensure the filing of all clinical trial documentation in eTMF and paper TMF as assigned.

Requirements

• In-depth knowledge of clinical drug development processes and experience applying GCP, ICH, and FDA requirements.
• Solid knowledge of clinical research study protocols and processes; ability to incorporate and adhere to GCP and regulatory standards.
• Ability to develop study processes in support of a clinical study design.
• Demonstrated knowledge in several areas related to clinical research: human anatomy, subject protection, regulatory requirements, study design, and study execution.
• Demonstrated skills in implementing tools for effective study management, identifying and implementing solutions to address study issues, and overcoming obstacles.
• Demonstrated skills in cultivating relationships with healthcare professionals and cross-functionally with co-workers from both the Sponsor and KPS teams.
• Demonstrated ability to maintain composure and adapt to shifting priorities and competing demands.
• Excellent written and verbal communication skills, including the ability to generate concise summaries for different audiences, professional correspondence, presentations, reports, and training materials.
• Proficiency in word processing, spreadsheets, and databases (e.g., MS Word and Excel).
• Skilled at developing project timelines and milestones and working with the team to ensure milestones are met; adjusts appropriately when needed and communicates risks when necessary.
• Ability to identify and articulate risks and benefits of a plan.
• Strong communication skills to discuss with Principal and Sub-Investigators and their site staff, even in challenging situations such as recruitment, protocol deviations, and oversight.
• High attention to detail and accuracy; ability to ensure data accuracy and review data.

Qualifications

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