adesta - success is our attitude
adesta sees itself as a partner for customers as well as for freelancers. Each appreciate the high-quality, individual advice and support which they receive at adesta.
On behalf of our client, a world-renowned pharmaceutical enterprise with headquarters in the Rhine Main area, we are looking for a
Informed Consent Review Specialist (m/w/d) in Darmstadt
- TMF reconciliation, Quality Check and Discrepancy Documentation
- Read and review Informed Consent Forms - ICF (globally) and complete ICF Tracking / Attribute Log
- Ensure compliance and inspection readiness of Phase I-IV clinical trials
- Bachelor degree in life sciences (e.g. biology, chemistry, pharmaceutics)
- Experienced in clinical research for at least 1-2 years as CTA, CRA or study start-up specialist
- Extensively experienced in eTMF systems and Informed Consent creation / review
- Very fluent (spoken and writing) in the English language
- Knowledgeable in ICH-GCP regulation, other relevant guidance documents (e.g. FDA, EMA) and requirements of Informed Consent in major countries
Are you interested in this challenging freelance job? Then please submit your profile under specification of reference number 29-302-13161. If you have any questions, please do not hesitate to contact Mr. Jungclaus.