Clinical Trials Operations Associate

Location Netherlands
Discipline: Medical Device
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email: s.ozbeden@panda-int.com
Job ref: 15635
Published: 30 days ago

For a growing client, I’m in search of a Clinical Trials Operations Associate experienced in Clinical Trial document management.

RESPONSIBILITIES

  • Liaises with internal and external stakeholders to ensure successful study start up, maintenance, and study closure activities.
  • Collects, reviews, tracks, and files essential regulatory documents from clinical sites and ensure documents required for filing are complete and accurate and provided to appropriate functional representatives in a timely manner in the correct format.
  • Assists to perform final review, quality control, and approval of essential document package prior to drug release and submissions to IRBs/EC & Regulatory agencies.
  • Assists to set up, maintain, and manage Trial Master File and Investigator Site Files in accordance with Industry requirements and Regulations throughout study duration.
  • Performs document control specialist audits of Trial Master File as needed.
  • Performs document collection, tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), Amendments, site contracts, payments, invoices, and other study documentation.
  • Prepares, procures and tracks mailing of documents, supplies, or other study related materials.
  • Ensures clinical documents are available for review and audit by Quality Assurance department personnel and/or Regulatory agencies.
  • Conducts study closure activities such reconciliation activities, filing, and archiving of study documents. Provides additional clinical study start up and closure activities support for study teams as needed.
  • Attends, and participates in clinical team and R&D functional meetings as required – may be assigned to take the meeting minutes.
  • Updates and maintains tracking systems and tools with status of documents, contracts, invoices, etc.
  • Performs other duties as necessary as assigned by management.

PROFILE

  • Minimum of one (1) year of experience in a biotechnology/pharmaceutical industry or other related relevant experience; BA/BSc or equivalent experience preferred.
  • Significant experience with Clinical Trial document management.
  • Contract negotiation and/or administration experience preferred.
  • Demonstrated knowledge of regulatory requirements related to clinical trial document start up and retention.
  • Proven ability to build and maintain effective internal and external relationships and successfully interact with various functional areas and levels.
  • Excellent written and oral communication skills.
  • Experience using computer applications and systems including CTMS and Veeva eTMF.
  • In-depth knowledge of Excel spreadsheets, including formulas, lookups, and pivot tables.
  • Demonstrated experience and ability to manage multiple projects/prioritize.
  • Working knowledge of GCP and ICH guidelines and other industry regulations.

Interested?
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on     +31 (0)20 20 44 502
https://panda-int.staffingreferrals.com/meet/sozbeden1