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eTMF Reviewer I

4 months ago

Basking Ridge, United States PSG Global Solutions Careers Full time

Apply now and our proprietary system will quickly have you in front of a live recruiter.
The Opportunity
Description
We're looking for an eTMF Reviewer I, working in Pharmaceuticals and Medical Products industry in Basking Ridge, New Jersey, United States.

Job description:

  • Reviewing documents for quality review that are in company's eTMF system in the Functional QC workflow for Clinical Safety & Pharmacovigilance (CSPV) department to ensure compliance within timelines and on an ad hoc basis.
  • Running essential reports in eTMF for Functional QC.
  • Metadata tagging of the loaded documents, if needed, ie re-classification & re-upload into eTMF.
  • Assisting the Clinical Safety Startup team with activities as they relate to the study startup processes such as the preparation and development of SAE Flow Plans and Addendums.
  • Document Management and Development Activities - additional activities include updating Clinical Study startup templates, PowerPoint and other related guidance documents.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

Education:
  • Associates or Bachelors degree in relevant discipline, OR minimum of 2-3 years of pharmaceutical or drug safety/pharmacovigiliance or clinical study trial experience recommended
Requirements:
  • eTMF experience required
  • Veeva experience, a plus
  • Strong interpersonal & organizational skills
  • Proficiency in Microsoft Word, Excel, PowerPoint & Outlook preferred
  • Ability to work effectively with people at different levels of an organization and different cultures
  • Ability to execute and follow-through to completion and documentation
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Good communication skills

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?