Our client, a fast growing biopharmaceutical company, now seek an experienced Manager for Global Clinical Operations role based in their Dublin office. This is a leadership role, in a matrix team environment supporting global clinical studies.
The successful candidate will manage, coordinate and oversee global clinical studies and operational implementation at a functional and possibly program level according to ICH Guidelines, GCP, and company SOPs.
The hire will effectively lead the Global Clinical Operation Study Teams including in-house team members and those from CROs, vendors and other suppliers to achieve program and company goals.
Responsibilities of Clinical Operations Manager, Global role:
Responsible for operational input and oversight in designing, planning, initiating and completing global clinical trials.
Develop and coordinate operational plans for a clinical study or multiple clinical studies within a global development program.
Mentoring and training and career development of staff.
Work with various in-house functional groups with regards to operational issues of clinical studies including, for example, vendor oversight, safety reporting and processing, study drug supply plans, and clinical monitoring.
Manage the progress of global clinical studies and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
Oversee and where necessary take the lead in writing key documents including but not limited to study protocols, investigator’s brochures, CSRs, RFPs and study reference manuals.
Disseminate clinical project communications to appropriate functional groups.
Participating in or leading cross- functional initiatives aimed at developing or improving clinical operation process and SOPs as needed under the guidance of the Director of Global Clinical Operations.
Approval of CRAs at CRO and CRO study staff.
Requirements for Clinical Operations Manager, Global role:
Minimum of a Bachelor of Science degree. Advanced qualification is preferred.
9+ years of clinical research experience, 3+ years of which study management experience within a pharma / biopharma / CRO.
Previous management experience of direct reports, including mentoring and developing clinical operations team.
Global Phase III-IV clinical trial experience with emphasis in overseeing EU studies.
Strong working knowledge of GCP, ICH, EMEA and applicable international regulations and guidelines.
Project Planning experience including oversight of study deliverables, budgets and timelines.
Ability to anticipate and resolve problems.
Ability to utilize scientific and clinical knowledge to conceptualize study designs.
Ability to write, present and articulate clearly on scientific and clinical issues.
Collaborate and lead cross-functional teams (team matrix environment).
Some travel may be required (<30%)
Please contact Larry on +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
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