What are the responsibilities and job description for the Associate Director, Clinical Research position at Bracco Imaging?
We are seeking a strategic and results-driven Associate Director / 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
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
- Proven 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