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Associate Specialist, Early Stage Development, Translational Pharmacology - Belgium
Posted on : 22 April 2017
- 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 Transnational Pharmacology EU team.
- 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.
- 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
Bachelors degree in a Life Science related discipline or relevant work experience in clinical research.
- 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
- 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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