Job Description
Required to manage successful execution of multiple clinical studies/projects and lead cross-functional project teams in line with ICH-GCP guidelines, SOPs, SSPs and regulatory requirements.
The successful candidate will manage assigned studies from concept to final study report in line. This includes developing and executing study plans including setting project goals, leading risk assessment and management, planning resources and timelines, and study team oversight.
The ideal candidate will be an experienced Clinical Program Manager or Clinical Trials Manager in successfully providing oversight of clinical trials; who has excellent teamwork, communication, decision-making and organizational skills and ability to work effectively in a dynamic environment.
Responsibilities of Clinical Program Manager:
Lead protocol development for assigned studies.
Overall responsibility for management of essential documents and Trial Master File related to assigned studies.
Develop and maintain strong relationships with external stakeholders to identify new studies and manage ongoing collaborations.
Contribute to the oversight and execution of key operational strategies and processes.
Manage role and project-specific training.
Oversee the process of site visits and documentation of the visits.
Pre-emptively identify potential issues and proactively manage resolutions and put in place, where possible, measures to minimise issues and risk for assigned studies.
Contribute to preparation for audits and inspections, conduct, and follow-up as required both internally and at investigational sites for assigned studies.
Draft and finalise budgets, contracts. and roles and responsibilities prior to commencing study activities and manage throughout the lifecycle of the study.
Oversee Regulatory and Ethics committee submissions for assigned studies.
Responsible for vendor identification and management where required.
Take all reasonable precautions to ensure patient confidentiality is maintained.
Contribute to departmental and cross-functional SOP development and updates as required.
Requirements for Clinical Program Manager:
Bachelor’s degree in Science and/or medical or nursing background.
5+ years relevant Clinical Operations experience, ideally with experience as Clinical Study lead.
Proven ability to deliver project goals and mentor junior level employees.
In-depth knowledge of the Irish clinical trials environment.
Experience with drafting and managing Clinical Trial budgets an advantage.
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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