Director Clinical Research

We are seeking a strategic and results-driven Director, Clinical Research to lead and manage clinical research programs from design through execution. This role is responsible for overseeing clinical studies, guiding cross-functional teams, and ensuring all research activities are conducted in compliance with regulatory standards and timelines. This leader will serve as a key partner to internal stakeholders, CROs, investigators, and vendors, ensuring high-quality execution and delivery of clinical programs.

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
• Review and approve vendor invoices and associated documentation
• Communicate critical study or personnel issues to senior leadership
• Contribute to the development, review, and training of clinical SOPs

Education
• B.S./B.A. degree preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Professional Experience, Knowledge & Technical Skills
• 10+ years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines
• Strong organizational, communication and teamwork skills. Ability to manage several projects simultaneously. Experience in diagnostic imaging field is desired.
• Ability to manage multiple projects/programs simultaneously
• Ability to manage investigators, consultants, vendors
• Excellent written and verbal communication skills with particular attention to communicating study information
• Taking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any task
• Ability to work independently, with minimum supervision
• Ability to work in a team
• Ability to deal with competing priorities, meet aggressive timelines within the assigned scope of the project

Core Relationships
• Medical Planning and Management
• Medical Affairs and Scientific Information
• Data Management
• Biostatistics
• Regulatory Affairs &Medical Writing
• Corporate Drug Safety
• Management Office
• Corporate Quality Management
• Clinical Research Quality Systems
• Global Legal Affairs