Senior Clinical Trial Associate
3 weeks ago
As a Senior Clinical Trial Associate at Pharmiweb, you will be part of the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
This role is responsible for coordinating and administering study activities from start-up to execution and close-out, ensuring quality and consistency of interventional study deliverables to time, cost, and quality objectives.
Key Responsibilities:- Collects, prepares, reviews, and tracks documents for the application process, as well as coordinates and tracks study materials and equipment.
- Assists in submitting proper applications/documents to EC/IRB and, where applicable, to Regulatory Authorities.
- Interfaces with Investigators, external service providers, and CRAs during the document collection process.
- Local administrative main contact and works closely with CRAs and/or LSAD for the duration of the study.
- Set-ups and maintains local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
- Ensures essential documents are uploaded in a timely manner to maintain eTMF "Inspection Readiness" and study documents are ready for final archiving and completion of local part of the eTMF, supporting the CRA in close-out activities for the ISF.
- Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
- Leads practical arrangements and contributes to the preparation of internal and external meetings, responsible for printing and distribution of documents such as letters and meeting minutes, and handling and archiving of study/country-related emails.
- Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study-related documents/material.
- Ensures compliance with local, national, and regional legislation, as applicable.
- Bachelor/Master degree.
- At least two years of experience as CTA in CRO or Pharmaceutical Company (mandatory).
- Excellent planning/organizational skills.
- Problem-solving attitude.
- Strong team player.
At Pharmiweb, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future.
Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
Pharmiweb, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at Pharmiweb whether it is for this or other roles.
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