Clinical Trial Manager

Clinical Study Manager

The Clinical Study Manager oversees end-to-end clinical trial activities across phases 1 through 4, ensuring high-quality execution, regulatory compliance, and alignment with overall clinical and regulatory strategy. This role involves leading cross-functional teams, managing external partners, and contributing to key regulatory submissions while maintaining data integrity and adherence to GCP/ICH guidelines.

Responsibilities

• Write, review, and refine clinical study protocols and related documents, including amendments, informed consent forms, and operational plans.
• Ensure regulatory compliance for phase 1–4 clinical trial activities, aligning all study processes with applicable regulations and guidelines.
• Contribute to the development of Investigational New Drug (IND) applications and other regulatory submissions by providing clinical operations input and documentation.
• Oversee contract research organizations (CROs), clinical research associates (CRAs), and third-party vendors to ensure delivery of high-quality work on time and within scope.
• Participate in CRO selection, including evaluation of proposals, capabilities, and performance metrics.
• Develop, manage, and track clinical study budgets, including forecasting, cost control, and variance analysis.
• Collaborate with internal and external teams to ensure clinical projects align with overall program and company strategy.
• Review and approve clinical study documents, including monitoring plans, site manuals, and other trial-related materials, to ensure consistency and quality.
• Ensure data integrity and compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and internal standard operating procedures (SOPs).
• Oversee site management activities, including site start-up, monitoring, and close-out, to ensure adherence to protocol and timelines.
• Coordinate and support clinical trial operations, including patient enrollment, data collection, and safety reporting.
• Provide leadership to cross-functional study teams, fostering effective communication and collaboration among clinical, regulatory, data management, and other stakeholders.
• Monitor vendor performance, identify issues or risks, and implement corrective and preventive actions as needed.
• Utilize electronic data capture (EDC) systems and other clinical trial technologies to support efficient study conduct and data management.
• Maintain strong relationships with study sites and principal investigators, serving as a key point of contact for operational and procedural questions.

Essential Skills

• 3–5 years of experience in the pharmaceutical industry and clinical trial management.
• Proven clinical project management experience, including planning, execution, and oversight of phase 1–4 clinical studies.
• Demonstrated experience in vendor management, including oversight of CROs, CRAs, and third-party vendors.
• Hands-on experience with clinical trial management and clinical development activities.
• Proficiency in budget development and budget management for clinical studies.
• Solid understanding and practical application of Good Clinical Practice (GCP) and ICH guidelines.
• Experience with electronic data capture (EDC) and other clinical trial systems.
• Bachelor's degree required.
• Proficiency in MS Office and other relevant software tools.
• Strong interpersonal skills with the ability to create and maintain productive relationships with study sites and principal investigators.
• Ability to lead and collaborate with cross-functional teams in a fast-paced clinical development environment.

Additional Skills & Qualifications

• Knowledge of neurological or rare disease drug development, particularly in ataxia, is preferred but not mandatory.
• Experience contributing to…