3rd Party Data Acquisition Lead
Job Description:
- Serving as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level, managing study start up, conduct and close out activities.
- Creating external data transfer agreements, ensuring external clinical trial data are in alignment with the client Standards and specifications to support data integration, analysis, and reporting.
- Help and advice in setting up infrastructure for external data, to flow into client Clinical data pipelines.
- Responsible for validation of all 3rd Party Data generated in clinical trial into client Clinical Data pipelines.
- Developing strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members.
- Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
- Representing client in interactions with key external partners as part of client CT3 3rd Party Data Acquisition team
- Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF
- Following 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.
- Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of client.
- Escalating issues to CT3 leadership appropriately
Technical/Functional Expertise
- Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
- Experience with all phases of drug development.
- Solid Experience in handling Clinical data acquisition and management from external/3rd Party vendors
- May lead study level negotiation and agreement for data transfer or integration on behalf of Client.
- should be able to function collaboratively (with some guidance) with all levels of employees , moderate supervision required
- Knowledge on FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate and Veeva TMF will be a plus.
