Maxis Clinical Sciences - Third Party Data Acquisition Lead

Job type : Remote

Shift : US timings

3rd Party Data Acquisition Lead (FSP) Role Profile :

- 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 Clients Standards and specifications to support data integration, analysis, and reporting.

- Help and advice in setting up infrastructure for external data, to flow into clients Clinical data pipelines.

- Responsible for validation of all 3rd Party Data generated in clinical trial into clients 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 clients CT3 3rd Party DataAcquisition 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 the 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 the 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.