Project Manager, Clinical Operations

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About the role

The Project Manager, Clinical Operations is responsible for managing operational aspects of all nutrition clinical trials, in addition to leading clinical trials as the clinical project manager. This position will provide leadership and organizational oversight of Nutrition clinical research activities, in direct assistance to the Medical Director of Clinical Research and will collaborate with cross-functional teams within Nutrition Research & Development to oversee facets of clinical research trials from ideation to publication.

Your responsibilities

Clinical Project Management:

• Ensure clinical trials are conducted in compliance with internationally accepted ethical standards for human research (International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines).
• Follow Human Research Participation Policy and clinical trial process as governed by the Clinical Research team
• Identify key deliverables, and publication expectations for single and multi-centered clinical trials.
• Manage the design and development of clinical trial protocol, case report forms, and electronic data capture
• Identification, selection, and evaluation of clinical trial site(s) and central laboratory(ies).
• Oversight of internal and external protocol approval process, including Institutional Review Board (IRB)/Ethics Committee (EC) submission.
• Track clinical trial progress, manage electronic systems, as applicable, and effectively communicate progress with project team.
• Identify clinical trial issues and develop solutions.
• Collaborate with cross-functional teams to maintain timelines.
• Develop, negotiate, and manage clinical trial site budgets.
• Develop and track total project budget actuals against projections.
• Coordinate data resolution activities.

Management of Clinical Research Operations:

• Manage the Clinical Research organization and personnel to maximize the quality, efficiency, and cost-effectiveness of clinical research activities.
• Coordinate clinical planning teams, working with Medical Directors and Clinical Project Managers to develop clinical study overviews, clinical study protocols, and clinical data repositories.
• Organize and track clinical study portfolios to provide transparency on study design, key deliverables, and progress to R&D leadership.
• Identify gaps in current internal capability and identify and develop systems to improve capability, including use of new tools and technologies.
• Work with Medical Directors and Clinical Research team to identify potential clinical study collaborators and to foster relationships with these collaborators.
• Maintain, update, and create SOPs as needed and ensure that all nutrition clinical SOPs are in strict compliance with internationally accepted ethical standards for human research (good clinical practices).
• Oversee the process and maintenance of all central project files and ensure they remain up to date and compliant
• Act as a liaison between clinical and global/regional regulatory teams to ensure appropriate clinical trial designs for registrations
• Act as a liaison to ensure understanding of regional ethics approvals and registrations depending on locations of clinical trials
• Provide oversight for electronic systems utilized by clinical project management team
• Collaborate with other functional roles within Clinical Research, Research & Development, and CITs, as needed
• Provide training and oversight to new clinical project managers and clinical trial assistants

The experience we're looking for

• Bachelor’s degree required, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area
• At least 2 years of clinical trial experience with extensive knowledge of ICH and GCP guidelines and strong drive to continuously remain current in updates to guidelines
• Understanding of traditional Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) skills (e.g., study planning, execution, data collection, and query resolution)
• Practical experience of clinical trial methodology, particularly study design and operational aspects
• Knowledge of clinical study protocols, case report forms, informed consent, and source documents
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