Clinical Trial Manager - contract role
|Job Title:||Clinical Trial Manager - contract role|
|Contact Name:||Larry O’Leary|
|Job Published:||about 2 years ago|
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research, now has a newly created Clinical Trial Manager role based in their Dublin office. This is an initial 6 month contract role however this should progress to longer term.
The successful candidate will provide significant operational input and oversight in planning; initiating, completing and reporting clinical trials across a Clinical Study or therapeutic area with an emphasis on early stage / start-up studies, registration clinical program to GCP and company SOPs.
Responsibilities of Clinical Trial Manager:
Provide clinical study management and execution with an emphasis on late stage clinical development according to SOPs.
Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program.
Oversee the progress of clinical study and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget.
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.
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 clinical study 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.
Disseminate clinical project communications to appropriate functional groups.
Attends strategic planning meetings.
Requirements for Clinical Trial Manager:
Bachelor of Science degree or similar Scientific or Medical qualification.
6+ years of clinical operations experience, ideally some of which as a CRA or Clinical Study Coordinator.
Experienced in Phase II start-up studies within a pharmaceutical or biotech environment or relevant CRO experience.
Experience leading large global clinical studies ensuring compliance with ICH, GCP and applicable international regulations and guidelines.
Project Planning experience including oversight of study deliverables, budgets and timelines.
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, mainly EMEA.
Please phone 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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