Clinical Operations Medical Staff Supervisor

1 month ago

Mississauga, Ontario, Canada Novo Nordisk Full time

POSITION SUMMARY
Accountable for the operational management of clinical site performance through effective coordination and communication with In-House Clinical Research Associates (CRAs), Field-Based CRAs, and the Trial Manager (TM) for designated clinical trials within the North America Clinical Operations (NACO) framework.

KEY RESPONSIBILITIES
Lead improvement and innovation initiatives for the NACO department or as part of a global team, aligned with strategic business objectives and future goals.

Oversee site performance throughout the entire lifecycle of assigned clinical trials, including but not limited to start-up, recruitment, retention, quality assurance, and data management. Exhibit technical proficiency in relevant areas, remain informed on new methodologies, and enhance knowledge of emerging trends and advancements.

Coordinate and facilitate site selection and activation activities, including the development of training tools and materials for Site Selection Visits (SSV) and Site Initiation Visits (SIV).

Review and authorize monitoring visit reports for assigned sites, identify and escalate any potential risks to trial delivery, and contribute to the development and implementation of mitigation strategies.

Develop and disseminate regional site communications, providing key updates and information to stakeholders.

Engage in active coaching, mentorship, and training of NACO personnel to cultivate insight and talent within the team.

QUALIFICATIONS
Bachelor's Degree required.
A minimum of 6 years of experience in the design, planning, and execution of Good Clinical Practice (GCP) clinical trials, with at least 4 years of direct site management and logistical execution experience in the pharmaceutical industry (Pharma/Biotech/CRO) is essential.

Proficient in ICH-GCP principles and their application to clinical trial design, planning, and execution.

Comprehensive knowledge and direct experience with the FDA or equivalent regulatory authorities concerning GCP clinical trials.

Demonstrated foundational skills in designing and implementing innovation and improvement initiatives, including necessary change management processes.

Exceptional communication skills (verbal, written, presentation) in English are required.

Proven collaborative and stakeholder management abilities.

On-site monitoring experience is preferred.

TRAVEL REQUIREMENTS
20-30% overnight travel may be necessary.
Field-based position.

We are dedicated to fostering an inclusive culture that values the diversity of our employees, the patients we serve, and the communities in which we operate.

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