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Job Details

DRA Clinical Trial Manager 50%

Company: CTC Resourcing Solutions
Location: Basel, Switzerland
Reference: 895502-P
Closing Date: 22 Sep 17
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

For one of our clients, a leading biopharmaceutical company, we are looking for a DRA Clinical Trial Manager, who will be responsible for preparing, submitting and maintaining Clinical Trial Applications according to quality standards and timelines as well as providing regulatory expertise to Clinical Trial Teams (CTT) and Health Authorities (HA).

Requirements:

Reference Number:         895502-P

Type of placement:         Contract, 9 months

Location:                        Switzerland, Basel area

 

 

Main Responsibilities:

 

  • Interact with internal departments or teams, affiliates and third parties as required to give regulatory input and guidance for clinical trials and their submission to European and international Health Authorities (HAs).
  • Prepare, submit and maintain Clinical Trial Applications (CTAs) to European and international HAs in accordance with the applicable regulatory requirements
  • Liaise with internal, regional, affiliate and/or CRO personnel to request and collect appropriate documents and, where applicable, to arrange submission
  • Interact with HAs and/or other parties regarding CTAs
  • Ensure proper running of the trial during its life cycle from a regulatory perspective
  • Ensure that timelines are met for submissions such as End of Trial notifications, Clinical Study Report synopsis, answers to HA questions, etc.
  • Maintain tracking sheets listing submission and approval dates per country for initial CTA, amendments, End of Trial notifications and submission of Clinical Study Report synopsis
  • Maintain the relevant sections of the Trial Master File for the duration of the clinical trial and prepare and QC the documentation before arranging final transfer
  • Attend and contribute to Clinical Trial Team (CTT) meetings, providing regulatory updates and information as required
  • Discuss country timelines and prioritize submissions in conjunction with relevant CTT members
  • Provide advice to CTT members on HA CTA submission processes and other related submissions, such as amendments, End of Trial notifications, etc.
  • Keep the relevant CTT members informed of the status of HA-related matters, including forwarding copies of relevant documentation in a timely manner
  • For applicable countries, liaise with internal, regional, affiliate and/or CRO personnel to manage submissions related to import/export licenses, including following-up on status of submission and providing input to tracking sheets
  • Contribute to update of existing and creation of new internal SOPs and processes
  • Final sign-off of IMP Shipment Approval requests for relevant departments
  • Keep country-specific information updated and inform other members of the CTA group accordingly

 

 

Qualifications and Experience:

 

  • Scientific Background or working experience in Global Clinical Trials
  • At least two years' experience of preparing and managing CTAs, or equivalent experience gained in a similar field
  • Good organizational and communication skills
  • Committed attention to detail 
  • Team spirit
  • The ability to prioritize tasks and work to deadlines
  • Customer oriented
  • Excellent MS Office skills
  • Fluent in both written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

 

 

Our offer:

 

  • A competitive salary and generous social benefits
  • The possibility for development and advancement within a constantly growing company
  • The innovative and stimulating atmosphere of a multicultural environment

Apply for this job: DRA Clinical Trial Manager 50%

Contact Information:

Address:  CTC Resourcing Solutions
Greifengasse 1
CH-4058 Basel
Switzerland
Reasons to work for CTC
Tel:  +41 61 695 88 66
Fax:  +41 61 695 88 67
Website:  Visit Our Web Site

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