Plan, communicate and implement the surveillance of the statistical programming activities performed by a CRO. Provide statistical programming support for Data Monitoring Committee charters and associated statistical programming deliverables.
Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed. Participate in departmental development activities including SOP and Work Instructions development.
The Analytical Manager is responsible for leading the analytical method development, validation, and transfers at the clinical stage. The individual is also responsible for the analytical review and approval of methods, protocols, and reports for validation and stability studies.
Review and validation of clinical study reports (CSRs); thorough understanding the connection between the data and the CSR. Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study.
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
Leads North American based clinical trials. May manage multiple small, early phase programs. Collaborates on global clinical trials. Reviews and approves study related plans generated by Clinical CROs and vendors.
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.