Job Description
Our client, a young science driven pharmaceutical company with product development pipeline moving through Phase Ib / II trials, now seeks a Clinical Project Manager to manage multiple clinical projects to GCP standards. They will provide oversight of all the responsibilities transferred by the development company to CROs and other vendors.
Person fit: Ideal candidate will be a Clinical Professional who is self-driven and capable of working on their own initiative in a fast paced dynamic environment.
This is a permanent role with a Pharmaceutical development company based in Dublin. This pipeline is set to progress into Phase III trials.
Responsibilities of Clinical Project Manager, EMEA:
Manage and co-ordinate clinical study design and implementation of global clinical programs over a number of therapeutic areas, according to GCP and company procedures.
Provide leadership and support for clinical studies at the company.
Responsible for operational input and oversight in designing, planning, initiating and completing clinical trials across a program / programs.
Expected to take the lead in writing clinical documents including study protocols, investigator’s brochures, and clinical study reports.
Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution.
Manage study budget, timelines, insourcing and outsourcing partners to required standards.
Participate in contract negotiations with suppliers and Vendor Management (CRO, central lab, eCOA and imaging vendors, etc.).
Requirements for Clinical Project Manager, EMEA:
Bachelor's Degree in Science, healthcare or similar.
4+ years' working as a CRA and then Clinical Project Manager with Phase II / III trials in either CRO or pharmaceutical company.
Monitoring and project management experience.
A willingness to deal with international teams working in different time zones.
Broad therapeutic experience and scientific knowledge in Oncology, Neurology or complex studies is a distinct advantage.
A flair for scientific writing (protocols and reports) and fully conversant with the use of EDC in clinical trials.
Demonstrates ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders.
Results-oriented; effective ability to set and meet short-term and long-term goals.
Strong working knowledge of MS Office and Outlook.
Excellent communication, organization and decision-making skills.
Flexible in reacting to changing priorities in projects without compromising timelines and/or quality.
Some international travel may be required (<10%).
Please contact 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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