Clinical Affairs Manager (Finance)
Manages the resource planning, protocol development, execution, and documentation of all clinical evaluations conducted to support regulatory filings or marketing initiatives.
Oversees clinical program development with multiple functions (R&D/Engineering, regulatory, marketing, data management, external vendors) to assure adequate resources are available to meet project timelines.
Manages the conduct of pre-market clinical trials. Facilitates collaborative efforts among the clinical study team, principal investigators, and data management on preparation of study protocols and related documents for sponsor-initiated clinical trials, and the execution and completion of such trials.
Reviews, approves, and supervises post-marketing clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, and clinical trial guidelines.
Maintains approval of all protocols and conduct of all clinical studies in adherence to both Company standards and government/industry regulations.
Ensures final accuracy of all clinical trials data and its timely availability, in appropriate format; works closely with Regulatory Affairs in developing plans for pre-submission and 510(k)/PMA submissions.
Leads or conducts training and initiation of clinical sites participating in clinical trials.
Develops and validates monitoring plans for all clinical trials.
Tracks and assures clinical milestones (i.e., enrollment, site startups, completion of studies) are met; oversees collection, synthesis and reporting of trial progress information.
Manages study data collection (monitoring), data entry, and timely data reporting.
Works collaboratively with site investigators to assure proper conduct of clinical trials (IRB approvals, patient recruitment, enrollment, follow-up procedures).
Supports study investigators in preparation of oral and written presentations of clinical results for presentation at scientific meetings and/or publication in scientific journals.
Prepares clinical study reports and collaborates with Regulatory Affairs in preparing regulatory filings and reporting study data to FDA or foreign Competent Authorities as necessary.