675k
... management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains ...
India, Hyderabad
View vacancy675k
... management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains ...
India, Gurugram
View vacancy11k
... always contact candidates via our corporate accounts and platforms. Please check to see whether the role you are interested in is posted on our career website. TMF Group is a leading provider of administrative services, helping clients invest and operate safely around the world. As we're a global company with 11,000+ colleagues ...
675k
... management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains ...
India, Hyderabad
View vacancy22k
... complex projects. - Proficiency with Microsoft Office (Excel, PowerPoint, Word), project planning software, and standard clinical research systems (CTMS, EDC, IXRS, TMF). - Ability to thrive in a matrix environment, value teamwork, and embrace Parexel's High-Performance Culture principles. Bachelor's degree in a science or medical-related ...
India, Hyderabad
View vacancy... documents. * Ensure compliance with ICH-GCP, SOPs, protocol requirements, and regulatory guidelines. * Maintain Investigator Site Files (ISF), Trial Master Files (TMF), and essential study documents. * Report adverse events (AEs) and serious adverse events (SAEs) as per protocol. * Coordinate with Principal Investigators, sponsors, ...
- Remote
- Hybrid
- On-site
- Contract
675k
... released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - ...
675k
... management of duplicate ICSRs. - Activities related to SPOR / IDMP. - Quality review of ICSRs. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. - Maintains ...
India, Hyderabad
View vacancy