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Job Details

Early Phase - Senior Clinical Study Manager - Small Growing Pharma !

Company: Barrington James Clinical
Location:
Reference: js-earlyphasestudymanager
Closing Date: 08 Sep 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Snr Study Manager !

Requirements:

Position: Senior Clinical Study Manager

Location: UK (Flexibility to work from home)

Salary: Competitive – will be realised upon application

 

I am currently partnering an exciting small pharmaceutical company that are looking to hire a Senior Clinical Study Manager to work on a broad therapeutic range. This particular client are looking to build an Early Phase division from there UK office! This innovative department will allow the selected candidate to join a brand new department and be directly involved in setting it up!

Requirements for the position:

The Clinical Study Manager would provide oversight from study start-up to drive database lock through completion of CSR for Early Phase studies in Europe. These activities would include but not limited to:

Responsible for study management (study oversight) from study planning phase to completion of the CSR/Archiving in compliance with Good Clinical Practice (GCP) und Standard Operating Procedures (SOPs)
Vendor Selection/Vendor Management
Budget and Timeline Management
Review study metrics and manage risks for successful completion of studies Review study data and reports for trends and escalate as appropriate
Develop, review and finalize study documents to meet study requirements
Managing Feasibility assessments performed on investigator sites

Review visit reports
Conduct co-monitoring
Manage deliverables (study protocols, case report forms, study manuals and templates, statistical analysis plan (SAP), tables, figures and listings (TFLs), clinical study reports (CSR), IVRS preparation and eCRF development with the CRO for Data Management.)
Ensure Sponsor Oversight File is complete and ready to archive when the TMF is received
Complete TMF audits at vendor in preparation for transition to ATL at study end to ensure completeness before ATL archives
Creating and review of relevant SOPs

Key requirements for this position  

Relevant life science degree.
Knowledge of regulatory requirements and guidelines (GCP and ICH) necessary for Clinical Research.
Previous clinical study management experience
PC literate
Self-motivated, responsible, committed, flexible, problem solving
Communication
Organisation
Time Management

 

For more information, please do not hesitate to reach out!

jsalmon@barringtonjames.com

01293 77 66 44

 

 

Apply for this job: Early Phase - Senior Clinical Study Manager - Small Growing Pharma !

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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