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Associate Specialist, Early Stage Development, Translational Pharmacology Brussels Belgium,  

Posted on : 10 April 2017

Project Description

Associate Specialist, Early Stage Development, Translational Pharmacology-CLI005619DescriptionMSD 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 based in Brussels, Belgium.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 stewardQualificationsRequired 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.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.Are you interested in contributing your know-how to a dynamic and innovative environment that allows you to show initiative and that offers long-term perspectives in an international environment?Then please apply online by: Friday 28th April 2017Job: Clinical Research (Non-M.D.) Job Title:Associate. Specialist, Early Stage Development, Translational PharmacologyPrimary Location: EMEA-Belgium-Brussels-Capital Region-BrusselsEmployee Status: RegularNumber of Openings: 1Company Trade Name:MSD Job Segment: Pharmacology, Medical Research, Clinical Research, Project Manager, Law, Healthcare, Technology, Legal



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