Associate Director, Clinical Research

Key Responsibilities

• Lead and oversee clinical research programs and multiple clinical studies
• Author and finalize study protocols for interventional, non-interventional, and retrospective studies
• Identify, select, and qualify investigational sites
• Manage and supervise CROs, vendors, consultants, and clinical study staff
• Ensure compliance with ICH/GCP guidelines and applicable regulatory requirements
• Conduct or oversee site visits and monitoring activities as needed
• Review informed consent forms and maintain accurate Study Master File (TMF) documentation
• Plan, coordinate, and lead investigator meetings and site training sessions
• Oversee safety reporting processes, including adverse event training and SUSAR submissions
• Manage clinical data flow, including query resolution and CRF tracking
• Coordinate clinical supply logistics, including shipment, accountability, and returns
• Track patient enrollment and proactively resolve site or study issues
• Maintain and update Clinical Trial Management Systems (CTMS)
• Ensure proper documentation and filing in relevant systems (e.g., TMF, Expresso)
• Oversee study budgets, vendor payments, and investigator payments
• Communicate critical study or personnel issues to senior leadership
• Contribute to the development, review, and training of clinical SOPs

Qualifications

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred)
• Significant experience in clinical research with progressive leadership responsibility
• Strong expertise in ICH/GCP guidelines and regulatory requirements
• Prominent experience managing CROs, vendors, and global clinical trials
• Demonstrated project leadership and organizational skills
• Excellent communication and stakeholder management abilities
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment