Clinical Project Manager, Global role
Our client, a rapidly expanding commercial stage biopharmaceutical company based in Dublin, who are progressing a number of assets through phase II & III clinical development stages have now approved a Clinical Project Manager role.
This position holder will initially work from home office and then transition to hybrid of home office and company's Dublin office towards end of year.
Key Remit: provide oversight of all the Clinical Operational activities for Global Clinical Trials where responsibilities have been transferred by the development company to CROs and other vendors, ensuring compliance with GCP and company SOPs to meet close-out timelines.
Person fit: Ideal candidate will be an experienced Clinical Project Manager of global Phase II / III trials in the pharma / biopharma industry, who is self-driven and capable of working on their own initiative in a fast-paced dynamic environment.
Responsibilities of Clinical Project Manager:
Responsible for operational input and oversight in planning, oversight, management and close-out of clinical trials across a program / programs according to GCP and company SOPs.
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.).
Expected to take the lead in writing clinical documents including study protocols, investigator’s brochures, and clinical study reports.
Requirements for Clinical Project Manager:
Bachelor's Degree in Science, healthcare or similar.
4+ years' experience as Clinical Project Manager with Phase II / III trials in either CRO and/or pharmaceutical company; ideally with vendor management experience (CRO, central lab, eCOA and imaging vendors).
Broad therapeutic experience in close-out of Clinical Trials through project closeout, in line with timelines.
Experience participating in Clinical Operations related projects with cross-functional stakeholders.
Proven understanding of Inspection Readiness/Regulatory considerations for this role.
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.
Flexible in reacting to changing priorities in projects without compromising timelines and/or quality.
Fully conversant with the use of EDC in clinical trials.
A willingness to deal with international teams working in different time zones.
Excellent communication, organization and decision-making skills.
Strong working knowledge of MS Office and Outlook.
Some international travel may be required (<10%).
Please phone Larry on +353 (0)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