Precision for Medicine is hiring a

Documents Specialist II

Budapest, Hungary

Documents Specialist II Position Summary:

 

The Documents Specialist II is responsible for preparing TMF plans, document QC and indexing in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate.

 

Essential functions of the job include but are not limited to:

  • Perform document QC and indexing within eTMF for assigned studies
  • Monitor document submission and timely document process, to avoid developing a backlog; escalate as needed to eTMF Management for support
  • Distribute TMF metrics
  • Follow-up on document in clarification and ensure these are resolved timely
  • Manage the close-out activities of assigned studies, including timeline for final document submission, wrap up of document processing, close out of all documents in close-out, requesting the eTMF export, transfer to the Client and get the Acknowledgement of Receipt.

 

Qualifications:

 

Minimum Required:

  • 4-year college degree or equivalent combination of education and experience, ideally in a business, scientific or healthcare discipline
  • Minimum 2 - 3 years of experience with TMF and/or eTMF

 

Other Required:

  • Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
  • Ability to speak English proficiently (professional level)

 

Competencies:

  • Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
  • Demonstrates solid interpersonal skills
  • Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
  • Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
  • Communicates both verbally and in written form in an efficient and professional manner
  • Demonstrates values and a work ethic consistent with Precision Values and Company Principles

 

 

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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