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