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Job Details

Start-up Assistant (Munich, Germany)

Company: Covance
Location: Munich, Germany
Reference: 2018-20146
Closing Date: 25 Jul 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

Requirements:

Job Overview

Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

We are currently seeking a proactive, driven Start-up Assistant to join our expanding team in Munich, Germany (office based).

You will have a great opportunity to develop yourself and also to learn from the best.

 

Job summary:

Provide administrative support to the Start Up team through contact and liaison with investigative sites during study maintenance and – when assigned – site start-up (SSU) activities. Assist the regional document review team with uploading study documents to eTMF. Administer the signature process for site contracts and related documents. Support collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team.

 

Responsibilities:

Duties may include, but are not limited to:

  • Assist in the collection, review, processing and tracking of regulatory & investigator documents required for study site activation and maintenance in accordance with applicable SOPs, GCP, ICH guidelines, and/or Study specific requirements and plans
  • Follow-up with investigative sites regarding document completion/submission.
  • Maintain and update document tracking information in CTMS, eTMF and other study specific systems.
  • Responsible for maintenance of site address and personnel information in the study database of allocated country (ies). Assist in tracking study personnel changes an assist the processing of new documents according to GCP/ICH guidelines.
  • Assist with revision of required study documentation as advised when study amendments occur.
  • Assist in the preparation of new investigator submission packages to Central/Local
  • Ethics Committees as appropriate.
  • Where appropriate liaise with Ethics Committee(s) regarding investigator submission/approval issues.
  • Support performance of quality reviews of documents in accordance with instructions of senior staff and relevant processes.
  • Administer the signature process in accordance with defined processes for all site contracts and related documents. Track and maintain appropriate databases in support of site contract activities
  • Liaise with relevant Sponsor and Covance teams to ensure appropriate site and
  • Sponsor signatures are obtained for relevant documents and track and progress site contracts and review requests in accordance with management instructions.
  • Where trained to do so, act as subject matter expert for the creation of investigator site budget using appropriate software.
  • Assist with data entry and admin support to the document review team regionally.
  • Assist with eTMF uploading of study documents.
  • Upload, check, correct and maintain study documents for document review in the study eTMF regionally and send study documents for document review to eTMF archivist after release.
  • Provide study documents for document review to the client as per study specific
  • Investigator Package Plan
  • Perform other duties as assigned by management.

Education / Qualifications

Minimum Required:

  • High School Diploma or equivalent

Preferred:

  • Secretary/Medical Administrative and experience of clinical research activities

Experience

  • Basic knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project teams and investigative sites preferred.
  • Basic understanding of the clinical trial process

THERE IS NO BETTER TIME TO JOIN US!

Apply for this job: Start-up Assistant (Munich, Germany)

Contact Information:

Address:  Covance- Munich


Germany
Tel: 
Fax: 
Website:  Visit Our Web Site

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