Clinical Project Manager
|Contact Name:||Larry O’Leary|
Our client, a growing commercial pharmaceutical company based in Dublin, now seeks a Clinical Project Manager to manage the day to day activities of the clinical studies. This hire will work directly with both internal and external stakeholders to ensure timely and high-quality delivery of the ongoing clinical trials.
The successful candidate will work with the CRO to drive the scope of service agreements, budgets, plans and detailed timelines, ensuring that performance expectations are met.
Person fit: Ideal candidate will be; a dynamic individual, who is self-driven and capable of working on their own initiative in a start-up environment. This hire must be willing to travel internationally, circa 20-25%.
This is a fixed term contract role based in Dublin, with the view to go long-term as the company continues to grow.
Responsibility for Clinical Project Manager:
Enable studies progression by ensuring compliance with relevant regulations and guidelines.
Manage the process to develop, review and contribute to Clinical activities.
Oversee planning and communication for investigator meetings and/or site and CRA training.
Perform financial management, including review and approval of site and vendor invoices.
Manage and support the vendor(s).
Oversight of the CRO processes and timely and quality filing of trial related documents/TMF.
Travel to CRO/vendor facilities and/or investigative sites as required.
Organise and manage internal team meetings, including trackers and follow up on actions and other trial-specific meetings.
Responsible for the development, review and implementation of departmental SOPs and processes.
Requirements for Clinical Project Manager:
BSc or MSc with minimum of 5 years in project management for phase II to IV clinical studies.
Clinical trial management experience, including CRO/vendor management, monitoring of budget scope, and knowledge of all relevant clinical operational areas.
Hands on experience of project management tools e.g. MS project and excel
Experience working in or developing multidisciplinary teams to set up, and conduct clinical studies, preferable in the US and the EU.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
International and domestic travel is required.
Please contact Larry on 01-2302400 / +353 1-2302400 / firstname.lastname@example.org
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
Key Words: FDA, GLP, ICH, GCP, Clinical Research, Clinical Trials, Clinical Operations, Clinical Trial Management, CRA, Clinical Program Management, Clinical Project Management, Pharmaceutical, Biopharmaceutical, Medical Devices, Dublin, Ireland.