Associate Director, Clinical Research

Bracco Imaging; Princeton (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Bracco Imaging in Princeton, New Jersey is seeking a strategic and results-driven Associate Director / Director, Clinical Research to lead and manage clinical research programs from design through execution. This role will oversee clinical studies and guide cross-functional teams, ensuring compliance with regulatory standards.

The ideal candidate has significant clinical research experience and the ability to manage multiple priorities in a fast-paced environment. Strong expertise in ICH/GCP guidelines is crucial.

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.

Responsibilities

• Lead and oversee clinical research programs and multiple clinical studies.
• Author and finalize study protocols for different types of studies.
• Identify, select, and qualify investigational sites.
• Manage and supervise CROs, vendors, and clinical study staff.
• Ensure compliance with ICH/GCP guidelines.
• Conduct or oversee site visits and monitoring activities.
• Review informed consent forms and maintain accurate documentation.
• Plan and coordinate investigator meetings and site training.
• Oversee safety reporting processes.
• Manage clinical data flow, including query resolution.
• Coordinate clinical supply logistics.
• Track patient enrollment and resolve study issues.
• Maintain and update Clinical Trial Management Systems.
• Ensure proper documentation in relevant systems.
• Oversee study budgets and vendor payments.
• Communicate critical study issues to senior leadership.
• Contribute to the development and training of clinical SOPs.

Job description

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