Job Description
Our client are enjoying strong growth, both financially and operationally, with a number of new clinical studies adding to what is already a strong pipeline. They now need to hire a Head of Clinical Operations, who report directly to the CEO. This will be a 12 month contract.
The successful candidate will be responsible for the execution of operational strategies of the Clinical and Pharmacovigilance functions and their alignment with company strategy, objectives and culture. This hire will lead and present ongoing operational plans and status reports to the CEO, as required.
The ideal candidate will have previous experience in oversight of large-scale financial management at the portfolio and functional levels, ensuring all is completed in line with ICH, GCP, company SOPs and regulatory requirements.
Key responsibilities for Head of Clinical Operations:
Lead operational strategies and plans for clinical programs and functions through appropriate leadership, direction and expertise.
Responsible for ensuring clinical trials are managed according to all regulatory requirements, guidelines and SOPs efficiently and within budget.
Line Management and guidance of the Clinical Project Management team.
Lead and contribute to policy development and strategic planning of the company.
Build and foster strong relationships with internal and external stakeholders such as Chief Investigators, internal committees, partners, investigator/site research team members.
Oversight of the operation of committees with responsibility for the scientific direction of the clinical program, the safety and medical oversight of the study portfolio.
Identify program risks and develop and implement mitigation strategies.
Recruitment, development and succession planning for staff with responsibility for study management.
Owner and author of SOPs relevant to study management.
Ensure staff are appropriately trained and comply with company policies, applicable SOPs and regulatory requirements and quality standards.
Represent the company at national and international meetings and conferences, as required.
Requirements for Head of Clinical Operations:
Minimum Bachelor’s Degree in Science and/or medical or nursing background.
10+ years relevant Clinical Operations experience, with progression to Director level.
Experienced in utilizing scientific and development knowledge to anticipate and address Clinical Development and Operations related challenges during clinical study execution.
Proven experience and a record of strong line management and supervisory experience of senior managers, program managers, etc.
Experienced in negotiating contracts on behalf of Clinical Operations department.
Experienced in managing challenging situations, including performance issues requiring personnel or contract termination.
In-depth knowledge of the Irish clinical trials environment.
Business acumen and financial / budgetary management experience is required.
Excellent communication skills with the ability to represent the company at an international
level.
For further details please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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