020 3198 1686

Senior Clinical Study Manager in Oxford, Oxfordshire, England

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Location
Oxford, Oxfordshire, England
Salary
£ 450.00 - 550.00 Per day
Job type
Contract
Category
Clinical/Medical
Job Id
38983
Posted on
10 May 2017
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About the Role:

Lucy Stendall is recruiting for a Senior Clinical Study Manager to join a growing biopharmaceutical company who specialise in the development of innovative gene based medicines at their site based in Oxford on a contract basis for 12 months initially.

The main purpose of the role will be:

- Management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant ATMP guidelines and all applicable laws and regulations

- Study team coordination and leadership

- Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality

- Responsibility for preparation of study documentation and coordination of document review, e.g. protocols, IBs, DSURs, ICFs, CSRs

- Selection and oversight of assigned CROs, vendors or contract monitors (CRAs), as appropriate

- Selection of suitable clinical sites in collaboration with other members of the study team or CROs, as appropriate

- Periodic co-monitoring with contract CRAs or CROs as necessary for each study, to ensure high quality monitoring and site management

- Set up and management of clinical contracts (including Clinical Site Agreements)

- Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Manager for regulatory submissions

- Preparation of study budgets, forecasting and accruals

- Thorough documentation of study team activities, decisions, actions and risk assessments

- Active management of clinical trials supply requirements in collaboration with Clinical Trials Supplies Manager and Head of Quality

- Oversight of TMF creation and maintenance by Clinical Trial Administrator, to ensure 'inspection-readiness' of documentation at all times

- Active acquisition and furthering of therapeutic area knowledge appropriate to assigned studies

- Assist with departmental development work e.g. SOP review/writing and process improvements initiatives

- Develop and maintain relations with KOLs

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

- BSc or equivalent industry experience

- Thorough documentation of study team activities, decisions, actions and risk assessments

- Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc.)

- Thorough knowledge of the clinical development process, ideally from first in human through to regulatory filing for marketing, experience in early phase (I-II) studies.

- Excellent working knowledge of GCP and current clinical trial legislation

- Travel in the UK and abroad periodically if needed

- CRA/monitoring experience, Advanced Therapy Medicinal Product experience and experience of EDC and eTMF; comfortable with electronic systems e.g. CTMS as well as either CNS or Medical Device experience would be preferable.

For more information or to apply for this position, please contact Lucy Stendall on [... Click Apply...]733 or by email on [... Click Apply...]. Alternatively, please click on the link below to apply online now.

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