Job Description
Clinical Study Manager - contract role
Our client is a fast growing highly profitable multinational biopharmaceutical company based in Dublin with an exciting pipeline of drug compounds at an advanced stage in research, now has a newly created role of Clinical Study Manager. This is an initial 6 month contract role with strong potential to extend / go permanent.
The successful candidate will support the design and manage operational activities related to the planning, implementation and reporting of clinical trials at a study level/across multiple studies according to GCP and company SOPs.
The ideal candidate will have Clinical study start-up experience (i.e. Phase I / II studies), in Global Clinical Studies in the pharma / biopharma industry. Strong European regulatory knowledge is preferred and availability at relatively short notice.
This position requires candidate to work in the company’s Dublin office a majority of their working week.
Responsibilities of Clinical Study Manager:
Manage and co-ordinate clinical study design and implementation at a program and functional level according to GCP and company.
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 / programs.
Expected to take the lead in writing clinical documents including study protocols, investigator’s brochures, and clinical study reports.
Lead clinical study and cross functional team to make key decisions related to strategy and issue resolution.
Manage study budget, timelines, insourcing and outsourcing partners to required standards.
Mentoring and training and career development of staff.
Requirements for Clinical Study Manager:
Bachelors Degree in the sciences or RN.
6 years’ work experience in life sciences or medically related field, including 5 years of supporting biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a pharmaceutical, biotech or CRO company).
4 years direct experience in a Clinical Operations / Global Clinical Studies (not device) with strong European regulatory knowledge.
Broad therapeutic experience, ideally experience in; Oncology, Gastrointestinal, Neurology, Cardiovascular.
Clinical study start-up experience required i.e. Phase I / II studies.
Experience participating in Clinical Operations related projects with cross-functional stakeholders.
Participation/engagement in Influence/Negotiation at Study Level/Project Level.
Participating in contract negotiations with suppliers and Vendor Management Experience (CRO, central lab, eCOA and imaging vendors).
IDMC, Charters.
Understand Inspection Readiness/Regulatory considerations for their role.
Some travel may be required (<10%).
Please phone Larry on +353 (0)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