Clinical Operations Manager
Posted on Mar 17, 2019 by Hobson Prior
Day to day interaction with the CRO and trial sites to ensure sponsor's oversight responsibilities.
Implementation, monitoring, supervision and direction of the assigned clinical trial(s).
Ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality / GCP standards.
Maintenance of Trial Master File (TMF) in strict compliance with ICH/GCP and internal Standard Operating Procedures (SOPs).
Regular update of all trial information databases and tracking systems in order to manage accuracy of information.
Facilitate interactions with relevant internal functions that are part of the Clinical Project Team.
Development / preparation clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors.
Ensure optimal administrative / operational monitoring of clinical trials.
Development / preparation of relevant sections of clinical trial protocols and related documents in collaboration with CRO's.
Development of clinical sections of regulatory documents.
Review the data coding using MedDRA and WHO drug classification.
Clinical and pharmacovigilance databases reconciliation.
(Minimum) Master of Sciences or equivalent.
(Desirable) Pharm.D. or Ph.D. or equivalent.
5+ years in relevant functions in the Pharmaceutical Industry, or equivalent.
Proven ability to interact collaboratively in a cross-functional environment required.
Subject matter expertise in Clinical Operations and related activities.
Previous experience conducting clinical trials in Europe/US and some Asia-Pacific regions in an outsourcing model is necessary, along with a working knowledge of the EMA and FDA clinical/regulatory environment.
Good knowledge of GCP and other relevant ICH/regulatory guidelines.
Willingness to travel domestically and overseas, if required.
Fluent in English, both written and verbal. Any additional language is a "nice to have".
Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint.
Will be required to coordinate, participate and make positive contribution to team meetings.
Will be expected to understand and comply with GCP requirements as well as the company's relevant Policies, SOPs and WIs. Will participate in internal and external audits as well as regulatory inspections.
Will be expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowledge and experience with other team members.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life science recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.