Associate Manager, Clinical Operations - Hertfordshire

CK Clinical
South East England
10 Feb 2018
15 Feb 2018
Contract Type
Full Time
Russell Oakley is recruiting for an Associate Manager in Clinical Operations, Neurology to join a Pharmacuetical company at their site based in Hertfordshire on a permanent basis.

This position will be allocated to the Epilepsy programme. The primary responsibilities will be to lead two ongoing extended access programmes (~50 patients) and also act as a regional EU manager for a global phase III study in Lennox Gastaut syndrome. The role will also potentially cover additional activities across the programme supporting studies in paediatric epilepsy.

Further responsibilities will include:
Clinical Trial Management:
Responsible for managing a small study or managing components of a larger multi-country or regional study as a Regional lead. Proactively addresses study issues and escalates as appropriate Supports study budget management by reviewing invoices, providing input into study budget development. Provides input to support site selection process
Clinical Trial Execution:
Coordinates designated part of operational clinical research activities for one or more small studies. Oversees execution of studies according to ICH/ GCP guidelines. Monitors/ tracks the study progress using clinical trial management tools and systems. Facilitates patient recruitment/retention. May undertake co-monitoring activities.
Document Creation and Management:
Manages the development of site manuals, monitoring manuals and other study documentation.
CRO / Vendor Management:
May serve as point of contact to CROs and / or study sites. Contributes to site, CRO, and / or vendor assessment and selection. Provides oversight of vendor activities and coordinates designated CRO activities. Manages technical vendors.
Resource Management:
Recognizes when current resources (tools, systems, vendors, etc.) need improvements and communicates to responsible supervisors. Assists others in managing time.
Financial Management:
Tracks the expenses of work teams to identify cost issues. Follows function's financial standards, guidelines and compliance requirements.
Matrix and Team Management:
Provides feedback to peers in a constructive manner. Supports employees by participating in project initiation, work transitions, and other development activities. May conduct training where appropriate.
Complies with all applicable laws / regulations of each country in which we do business. Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reports legal, compliance and ethical violations in a timely manner.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- BS/MS in relevant field
- Experience in clinical operations methods and processes in an industry setting.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41253 in all correspondence.

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