You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Vacancy details
Vacancy description:
Job Code:
J823757
Job Title:
Manager, Clinical Operations
Job Category:
CRM (Clinical Research Management)
Contract:
Locum/Temporary
Discipline:
Clinical Project Manager, Clinical Team Manager, Clinical Operations
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
15 Aug 2008
An exciting opportunity for an experienced clinical research professional to join a growing biotechnology company based in Berskhire. Specialising within vaccines this is an excellent opportunity to develop your career in earlier phase development.
Experience of handling CROs or having worked in CRO beneficial A self-starter, who will be able to act independently, and learn quickly, within a rapidly evolving environment but who can also work closely as part of a small team. A confident communicator, capable of interacting effectively with external contacts, and at every level within the company.
To manage and co-ordinate early phase clinical research activities for the company. This includes the management of several outsourced clinical research programmes. Provide input into translating commercial objectives into functional clinical plans Manage phase I and II clinical studies from the planning stage through to preparation of the clinical study report Identification, training and management of external project resources (consultants, contractors or CRO(s) for clinical, pharmacovigilance, data management, statistical and medical writing services Ensuring the service provided by CRO (s) is of the highest standard, on time and within budget Provide input into development of internal systems and SOPs to ensure clinical studies are carried out in compliance with current regulations Managing approved clinical trial budgets for several projects Evaluating phase I units and potential Investigators for suitability to undertake each study Negotiating contracts with Investigators, Study Monitors and CROs Developing and reviewing all study documents including preparation of Clinical Protocols, CRFs and CSRs Developing Data Management and Statistical Analyses plans with CRO(s) Overseeing ethics committee submissions Arranging and coordinating distribution of clinical trial supplies with the clinical supplies pharmacist
A Life Sciences degree and a strong interest in continued scientific development. A minimum of five years experience in clinical research, including study management across several territories, to ICH and FDA requirements Must have experience in the development of human vaccines or biotechnology products.
Keywords - Clinical Ops Manager Operations Berkshire clinical trials phase 1 medical writing CRO vaccine research
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Site by Redder