Senior Clinical Trials Compliance Coordinator

2 days ago

Hyderabad Secunderabad Telangana, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878
Clinical Trial Submission Management Senior Associate

The ideal candidate will play a pivotal role in ensuring technical compliance of our Clinical Trial submissions by effectively coordinating the flow of information between various functional areas, both internal and external. This vital position will be responsible for one or more Amgen products under development, ensuring clinical trial application approvals in the EU.

Key Responsibilities:

  • Support the assembly of submission packages and supportive documentation for regulatory deliverables to manage clinical trials.
  • Serve as the operational driver for Clinical Trial Submissions and notifications in a state-of-the-art regulatory document management system, maintaining tracking systems.
  • Critically coordinate Clinical Trial Submissions and notifications through the EMA CTIS system, performing accurate and timely input of data and documents into the EMA Clinical Trial Information System for Clinical Trial Applications, Modifications, and Notifications.
  • Act as the Single Point of Contact for incoming EMA CTIS notifications and alerts, monitoring them daily and swiftly dispatching incoming requests to cross-functional teams.
  • Be responsible for reviewing and triaging Requests for Information from Health Authorities through CTIS to relevant cross-functional teams, ensuring Requests for Information are tracked within the document management system.
  • Receive notification of compliant events from Amgen's Clinical Trial Registry System for input into CTIS within regulation timelines, ensuring efficient and timely data entry and communication of submissions to key process stakeholders.
  • Submit Clinical Trial Results to CTIS through the Marketing Authorisation Holder Access.
  • Support Sponsor High Level Administrator within CTIS with access requests.
  • Function as Subject Matter Expert for CTIS, providing intelligence and expertise on technical submission requirements and system processes.
  • Assist in defining, developing, and implementing processes to meet the evolving CTIS needs.
  • Evaluate issues that may impact submission processes or timelines within CTIS, escalating, informing, and resolving them.
  • Foster effective relationships and communication paths across local and functional organizations.
  • Enable efficiencies and seamless execution across the EU region countries.

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