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Job Details

PW 6737 Manager, Clinical Operations, Neurology

Company: AXESS
Location: Hertfordshire
Reference: PW 6737
Closing Date: 10 Nov 16
Type: Contract
Salary (£): Competitive
Benefits: Full Corporate Benefits package

Job Summary:

This is a high profile European regional clinical ops lead role for a global pharmaceutical company. You will lead 2-3 phase III insomnia studies in start-up/maintenance. The role will typically entail liaison with internal company functions, regional management of CRO/vendors to ensure optimal study/site start-up, optimal regional recruitment and facilitation of local operational budgetary and logistical issues



Top Global Pharma

Innovative, ethical and supportive working environment

Excellent transport links and onsite parking

12 month FTC with the possibility of extension


The Manager Clinical Operations will be responsible for:

Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and company standard operating procedures.

May lead the cross-functional team for designated study(ies) and/or may coordinate designated regional aspects of assigned global study(ies) under supervision of study Global Clinical Operations Lead.

Mentors less experienced staff, although this position does not involve Line Management.

Clinical Trial Management:

-           Has primary accountability for operational study level time, cost and quality deliverables

-           Manages overall budget for a regional or smaller study (e.g. Ph II)

-           Recommends sites to include or exclude from study

Clinical Trial Execution

-           Independently oversees all operational clinical research activities for a study or series of small studies

-           Oversees execution of studies according to ICH / GCP guidelines

-           Contributes to inspection preparations

-           May undertake co-monitoring activities

Document Creation and Management

-           Contributes to the development and/ or review of high level study related documents (e.g., PCS, Protocol, CRF etc.)

-           Oversees the development of study manuals and monitoring manuals

CRO / Vendor Management

-           Serves as first point of contact for company to CROs and/ or study sites for regional or smaller study (e.g., Ph II)

-           Evaluates vendor proposals against company’s terms and critical needs and partners with internal functions to define scope of work

-           Monitors and assesses vendor performance against contractual operational deliverables

Monitors progress of sites/ CROs/ vendors against requirements and leads discussion of current status and resolution of issues


·         Science graduate

·         Prior experience as a Clinical Study Manager

·         Proven track record of leading cross-functional teams, people coordination, mentoring of junior colleagues.

·         Experience Neuroscience indications preferable but not essential

·         Experience in budget management

·         Experience of CRO and technical vendor management essential to ensure delivery of complex multi-national outsourced studies to time and budget.

·         Full understanding of current ICH/GCP guidelines.


For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please click the Apply for Job button quoting reference PW 6737.

Only candidates with EU work authorisation will be considered.


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AXESS has been operating since 1990

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Apply for this job:  PW 6737 Manager, Clinical Operations, Neurology

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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