Job Purpose
The Manager of Clinical Affairs plays a key role in overseeing, managing, and reporting clinical research to support new product development and regulatory dossier maintenance at TriviumVet.
Responsibilities & Duties
The responsibilities of this role encompass a wide range of strategic and operational activities within TriviumVet’s clinical and regulatory functions; these include (but are not limited to):
Overseeing the planning, execution, and compliance of clinical studies, aligning with organizational objectives and regulatory requirements.
Developing and reviewing documentation, including protocols, SOPs, and data capture forms, to ensure compliance with regulatory standards and best practices.
Managing and monitoring ongoing clinical studies, including data verification, analysis, and interpretation, to ensure data integrity and regulatory compliance throughout the study lifecycle.
Providing leadership to a team of clinicians (veterinarians), proactively balancing business priorities and regulatory milestones to allocate resources, prioritise workload, and ensure execution of clinical programs in line with company objectives.
Collaborating closely with cross-functional teams to ensure alignment and synergy between clinical, regulatory, and other functions.
Ensuring adherence to relevant guidelines, including Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), to uphold the highest standards of research integrity and ethical conduct.
Maintaining deep and current knowledge of all relevant regulations underpinning new animal drug development in the US and EU.
Authoring and overseeing the preparation of regulatory submissions for international regulators, including the Center for Veterinary Medicine (CVM) and the Committee for Medicinal Products for Veterinary Use (CVMP).
Cultivating strategic relationships with key opinion leaders, investigators, and collaborators within the veterinary community, fostering partnerships to advance the clinical research agenda.
Providing strategic input in cross-functional project planning initiatives, collaborating closely with diverse teams to drive alignment across organizational objectives.
Planning and tracking project expenditure to aid in efficient resource allocation and budgetary management within the clinical and regulatory affairs function.
Qualifications and Experience
Honours graduate (minimum 2.1) in a relevant life science discipline; pharmacy, veterinary, MD preferred with a proven track record of achievement in clinical affairs.
At least 10 years of relevant professional experience.
At least five years’ experience in a people management role, leading and managing teams.
Proven ability to collaborate effectively with cross functional teams to support delivery of project objectives.
Extensive experience in clinical research and regulatory affairs within the healthcare or veterinary industry, with a proven track record of successful study execution and regulatory submissions.
Strong IT skills (MS Office/Excel) and some knowledge of biostatistics.
Other Information, Skills, Competencies
Possess effective communication and interpersonal skills, with the ability to engage and collaborate with diverse stakeholders at all levels of the organization.
Demonstrate the flexibility/adaptability necessary to work on multiple different projects at any given time.
Demonstrate strong problem-solving skills, with a keen eye for detail and a relentless commitment to excellence in all aspects of clinical study execution and regulatory compliance.
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