What are the responsibilities and job description for the Director Clinical Research position at Bracco Imaging?
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