Posted:3 months ago|
Platform:
Remote
Full Time
- Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start up, conduct and close out activities. - Create external data transfer agreements, ensuring external clinical trial data are in alignment with company Standards and specifications to support data integration, analysis, and reporting. - Help and advice in setting up infrastructure for external data, to flow into company Clinical data pipelines. - Responsible for validation of all 3rd Party Data generated in clinical trial into company Clinical Data pipelines. - Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members. - Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit. - Representing company in interactions with key external partners as part of company CT3 3rd Party Data Acquisition team. - Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF. - Follow procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes. - Liaise with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of company. - Escalate issues to CT3 leadership appropriately.
Thanks & Regards:
Abhinav Krishna Srivastava
Mob : +91- 9667680709
FCS Software Solutions Ltd.
Email: asrivastava@fcsltd.com
FCS Software Solutions
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