Job Description
Our client, a fast growing highly profitable multinational biopharmaceutical company, now seek a Manager for Global Clinical Trial based in their Dublin office. This role will lead the clinical study and cross functional team to make key decisions related to strategy and issue resolution. There is flexibility to hire this person as Senior Manager level, depending on the candidate’s qualifications and experience.
The successful candidate will provide oversight of all study related activities, facilitating communication and transparency with suppliers and sites, and addressing study related issues appropriately and professionally, to achieve program and company goals.
The preferred candidate will have a track record of successful project management and direct experience with clinical operations related responsibilities at a biopharma company, in accordance with regulatory guidelines and company procedures.
Responsibilities of Global Clinical Trial Manager:
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(s).
Study training and documentation, supplier oversight, including CRA management, Inspection readiness, and cross-functional collaboration relating to the assigned studies.
Build a network within the organization to drive clarity and compliance across clinical operations responsibilities.
Contribute to writing clinical documents including study protocols, investigator’s brochures, study manuals and plans, and clinical study reports.
Manage study budget, timelines, insourcing and outsourcing partners to required standards
Mentoring and training and career development of staff.
Requirements for Global Clinical Trial Manager:
Minimum of a Bachelor of Science degree. Advanced qualification is preferred.
8+ years of clinical operations experience, 2+ years of which global study management experience within a pharma / biopharma / CRO.
The candidate must have experience managing direct reports, including mentoring and training and career development of staff.
Proven background in study operations and supplier management, with effective cross-functional collaboration.
Global Phase III-IV clinical trial experience with emphasis in overseeing EU studies.
Excellent organizational and communication skills to manage projects.
Strong interpersonal skills and track record of managerial responsibility.
Strong understanding of Inspection Readiness requirements .
Problem solver, presents and drives solutions.
Self-Motivated, flexible and adaptable.
Effective relationship building.
Some travel will be required, mainly European.
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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