Senior CTA - outsourced to niche Biotech via small CRO

Location Ghent
Discipline: Clinical Operations, Clinical Research
Job type: Permanent
Salary: £€ DOE
Contact name: Harry Henson

Contact email: harry.henson@rbwconsulting.com
Contact phone: +441293364092
Job ref: 30380B
Published: 3 months ago
Expiry date: 30 Dec 2023 11:59
Startdate: ASAP

​​RBW Consulting are partnered with a growing, small sized CRO in their search to find a Senior CTA to be outsourced to one of their most trusted clients - a niche Biotech.

You will be working on Clinical Trials by assisting the Clinical Trial Manager with the conduct on you assigned studies, focusing on administration, coordination, and archiving. You will also assist with the inspection readiness of the Electronic Clinical Operations system for your assigned trials. You will report directly in to the CTA Manager. You will also support projects related to improvement/implementation of clinical processes and systems based on relevant experience , while also supporting the onboarding of new CTAs

Responsibilities

  • Assist the CTM and CTT with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)

  • Develop and adapt documents to trial specific requirements in collaboration with the CTM

  • Assist with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings and Investigator Meetings

  • Coordinate the filing of Trial Master File (TMF) documents in the (electronic) Trial Master File (TMF) part of ECO by reviewing completeness and correct use of ECO. Follow-up with the CTT on findings and provide support on how to use ECO.

  • Assist the CTM/COL to ensure that the Trial Operations TMF Documents are properly filed and made ready for archiving.

  • Act as Business Administrator in the eTMF system, by maintaining records and supporting close-out activities (including archival preparation) in the eTMF system. This includes: managing study records, country records and site records.

  • Provide logistical support to the CTT on vendor (e)TMF oversight activities

  • Assist the Global Head of Trial Operations with the development of department template documents and the organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)

  • Assist with the preparation of trial reports for the CTT and keep them up-to-date

  • Assist with signature collection of Confidentiality Disclosure Agreements, Purchase Orders, and insurance certificates in collaboration with CTM/ Vendor Management

  • Assist with other Trial Operations related activities based on relevant experience

Skills

  • High level fluency of English

  • 3+ years of experience as a CTA / Senior CTA

  • Extensive ICH-GCP knowledge

  • Experience with trial progress and metric systems (eg Electronic Case Report Form (eCRF), Interactive Response Technology (IRT), Interactive Voice/Web Response System (IXRS), and Veeva Vault)

Please apply here and Harry Henson will be in contact.