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Associate Specialist, Early Stage Development, Translational Pharmacology - Belgium  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description


Description
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
  •  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
  • We have an exciting opportunity for an Associate Specialist, Early Stage Development to join our Translational Pharmacology EU team.



Position overview:
  • The Associate Specialist will report to the Early Stage Development Operations and Outsourcing Lead and is an essential member of the clinical study conduct team. 
  • The person in this role will provide operational project support for Early Stage Development studies managed by the Translational Pharmacology Europe department.
  • The incumbent will have responsibility for in-house or on-site activities as well as for compliance with processes required to initiate, maintain, support and close out the early stage clinical trials managed by the department.



Role responsibilities:
  •  Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials.
  • Act as relationship manager with 3rd party vendors or with support groups such as ancillary supplies managements.
  •  Assemble and track availability of all essential documentation required for study conduct.
  • Provide professional presentation of study materials for investigator/vendor or country operations meetings.
  • Safety reporting tracking.
  • Liaise with sites and in house departments to ensure appropriate regulatory follow-up.
  • Site Visits: QC of trial binders and other study documentation for completeness, consistency and accuracy.
  • Review study budgets/clinical trial agreements for consistency with study protocol.
  •  Organization and documentation (minutes) of project team meetings.Create Essential Documents Repository.


Operational and project support activities, including, but not limited to:
  • Archiving and/or accountability for completeness of Trial Master File
  • Update, maintain and monitor CTMS to allow accurate project management, regulatory reporting and clinical grants payments
  • Follow-up/check final accountability of IMP and return or destruction as appropriate
  • Review study budgets/clinical trial agreements for consistency with study protocol
  • Updating of clinical and study planning databases
  • Possibility for SME roles: CTMS, TMF steward




Qualifications

Required Qualifications, Skills and Experience:
Bachelors degree in a Life Science related discipline or relevant work experience in clinical research.



Skills:
  • Understanding and knowledge of study protocols and study working documents, lab manuals, etc.
  • Interpersonal skills and ability to work in a team environment.
  • Advanced organization and planning skills.
  • Advanced computer skills: e.g. professional using of MS Office programs for daily business
  • Good understanding of the clinical research processes
  • Understanding of the ICH/GCP and local clinical trial regulations
  • English,Dutch and French – working proficiency, verbal and written.



Offer:
  • Our employees are the key to our company’s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. 
  • Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
  

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