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 role of Clinical Study Manager based in their Dublin office. This is an initial 6 month contract role.
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 late-stage, registration clinical program to GCP and company SOPs.
Responsibilities of Clinical Study 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 Study Manager:
Bachelor of Science degree or similar Scientific or Medical qualification.
8 years of clinical management experience, ideally 3 years of phase 3 study management experience 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.
Experience with Phase 3 studies and filings to FDA and Ex-US Regulatory Agencies.
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.
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
Follow us on: Facebook, Linked-in, twitter