Lead the development and implementation of submission ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA). Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.

Contribute to writing and reviewing of study related documents such as protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents Experience with single case unblinding Knowledge with early development activities and documents Contribute to writing and reviewing medical monitoring plans and other

Develop a robust timeline and plan for the overall program. Development or improvement of program processes to drive program efficiency Update program trackers and program update reports Assist with PMO deliverables for program health improvement initiative Take on project management remediation process which includes coordinating with program workstream leaders to manage

Lead and support the qualification and evaluation process for new service providers. Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution. Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, C