Clinical Trial Manager, EU region
|Contact Name:||Larry O’Leary|
Our client is focused on the discovery, development and commercialization of novel antibodies that are directed towards rare diseases. Rapid expansion has led to the need to create the appointment of an EU-based Clinical Trials Manager, to be based in their Dublin office and operate as part of a global team.
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company who are growing year on year.
Please note: this is an initial 12 month contract role. Candidates must be willing to travel circa 20 - 25% of the time, within EU region.
The main focus of this role: is to work closely with various internal team members and CRO as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with regulatory guidelines, company goals, and budgets.
Responsibilities of Clinical Trial Manager:
Manages the operational aspects of clinical trials
Manages the study project plan, including timeline, budget and resources
Manages CRO interactions, including sponsor oversight of operational functional activities.
Participates in protocol, CRF and strategy development, CSR preparation, NDA submission, as appropriate.
Prepares metrics and updates for management, as assigned.
Proactively identifies potential study issues/risks and recommends/implements solutions.
Participates in and facilitates CRO/vendor selection process for outsourced activities.
Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
Prepares and/or reviews/approves study-related documents.
Manages clinical monitoring activities ensuring compliance with GCP and applicable regulations.
Participates in the development, review and implementation of departmental SOPs and processes.
Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
Reviews site study documents, investigator contracts, and site payments.
Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
Requirements for Clinical Trial Manager:
Bachelor of Science degree required.
4+ years of related clinical trial / operations experience in the pharmaceutical industry or clinical setting.
Experience in managing outside vendors, e.g., CROs and other vendors.
Rare Disease and/or Oncology experience preferred.
Strong knowledge and experience of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required.
Ability to provide clinical expertise to a clinical development in a specified product area or project.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
Must display strong analytical and problem solving skills. Strong attention to detail is required.
Please contact Larry on +353 1 - 2302400 / email@example.com
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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