Our client, a highly ambitious young pharmaceutical company who now have approval for a Clinical Trials Manager (CTM) in line with their growth strategy, driven by additional clinical trial programs and patient recruitment needs.
Reporting to the Chief Operating Officer and working closely with a Lead Clinical Operations Consultant, the CTM will be a key member of the Company’s Clinical Operations team. This role has flexibility to work majority of time from home office, with some travel to company office for meetings, etc (possibly a few days per month).
The successful candidate will function as the study team lead, and will be planning, organising and coordinating all operational aspects of the Company’s clinical trials, from protocol development through to database lock, with an emphasis on Phase 2 and 3 registration clinical program to GCP and company SOPs.
Responsibilities of Clinical Trial Manager:
Provide clinical study management and execution with an emphasis on Phase 2 and 3 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 enrolment 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.
5 years of clinical management experience, ideally 2 years CTM experience of study management experience within a pharmaceutical or biotech environment or relevant CRO experience.
Experience of site monitoring and/or in a CRA role is preferred.
Experience leading Phase 2 and 3 studies ensuring compliance with ICH, GCP and applicable international regulations and guidelines.
Experience with filings to FDA and Ex-US Regulatory Agencies is desirable.
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.
Excellent communication and interpersonal skills; influencing internal and external colleagues without direct authority.
Must have budget management and project management experience.
Excellent computer skills; command of Microsoft Office.
Willing to travel domestically and occasional international travel
For further details, please phone Larry on +353 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
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