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Job Details

Freelance: Clinical Trials Manager - Switzerland

Company: Umbilical Life
Location:
Reference: GR/NY/CTM/SW
Closing Date: 23 Feb 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Gabriel Roberts of Umbilical Life is recruiting a Clinical Trails Manager to work with a fast expanding Pharma assigned to a key-project. They are looking for someone to start in February to work 1.0 FTE.

Requirements:

Responsibilities:

  • Lead defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and GCP guidelines
  • Serve as a member of one or more Clinical Operations study management teams (SMT) and as a member of the cross functional study execution team.
  • Partner with Contracts department on the development of site budget and clinical trial agreement (CTA) templates and on the negotiations with clinical sites. Ensure site payments are accurate and reconciled against patient visits.
  • Perform oversight and/or co-monitoring visits of clinical sites, as required
  • Review CRO monitoring reports and ensure completion of action items. Identify trends and risks. Escalate unresolved issues.
  • Partner with SET, vendors, and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled
  • Participate in routine and final data listings review
  • Participate in implementation and oversight of study systems
  • Plan investigator meetings and develop content and/or site training materials
  • Proactively identify issues and risks and propose mitigation

 

Qualifications:

  • BS/BA in Life Science or related discipline
  • 4+ years industry experience in clinical drug development 
  • Effective team player and ability to influence and collaborate with cross-functional clinical study teams
  • Effective written and interpersonal communication skills
  • Ability to manage aspects of assigned clinical trials
  • Independently manage assigned clinical study vendors
  • Ability to proactively identify and mitigate study risks.
  • Strong planning and organizational skills
  • Working knowledge of FDA & GCP regulations and guidelines
  • Ability to travel

 

Benefits:

As well as an extremely competitive rate.

 

For a confidential discussion please contact Gabriel Roberts at Umbilical

on +44 (0) 116 461 0070 or email Gabriel@umbilical-life.com

Apply for this job: Freelance: Clinical Trials Manager - Switzerland

Contact Information:

Address:  Head Office
Premier House 9 Rutland Street Leicester
LE1 1RE
England
Tel:  011 6 461 0070
Website:  Visit Our Web Site

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