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Lifelancer

Talent Hiring Platform in Life Sciences & Pharma

Associate I – TMF Operations

OperationsOperationsFull TimeRemoteMid LevelTeam 51-200Since 2020H1B No SponsorCompany SiteLinkedIn

Location

Romania

Posted

2 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree0.5 yrs expEnglish

Job Description

Associate I – TMF Operations

Lifelancer

• Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices. • Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format. • Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents. • Communicate directly with RMC Lead to report trends and issues relevant to the TMF. • Escalate any TMF Quality issues in a timely manner to RMC Lead. • Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers). • Perform additional tasks as assigned by their Line Manager.

Job Requirements

  • University Degree preferred
  • Minimum 6 months of relevant TMF experience
  • Knowledge of working within a highly regulated industry (preferably within CRO/Pharma industries)
  • Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions.
  • Possess excellent written and verbal communication skills to clearly and concisely present information.
  • Work with internal teams and can execute tasks under general direction, seeks assistance as needed.
  • Exercise sound judgment and ability to identify decisions requiring supervisory approval.
  • Demonstrate proficiency in Microsoft Word and Excel.
  • Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills.
  • General understanding of clinical research principles and processes.

Benefits

  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events

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