Responsibilities: Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data m...
Responsibilities: Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews, and approves engineering changes. Acts as core ...
Responsibilities: Maintain and update EDC user access across multiple clinical studies. Track and manage user access requests in coordination with CRAs and EDC vendors. Curate and maintain standardized tracking spreadsheets for both int...
Responsibilities: Ensure departmental or functional training plans in place and appropriate. Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time del...
Responsibilities: Leads, performs, and oversees data management activities for clinical studies and/or clinical programs. Performs hands-on clinical data management tasks to support clinical studies, including, but not limited to reviewi...
Responsibilities: Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock. Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical wri...
Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class...
Responsibilities: The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regul...