Clinical Study Manager

Axogen•Tampa, FL

17h

About The Position

The Clinical Study Manager leads the planning, implementation, execution, monitoring, and close-out of Axogen sponsored clinical studies. This position ensures adherence to applicable regulations, Good Clinical Practices, and industry standards governing research involving human subjects; and ensures that clinical studies achieve company objectives on-time and within budget.

Requirements

Bachelor’s degree (or higher) in a medical, scientific, or engineering discipline; (or commensurate combination of training and experience)
Minimum of 3 years of experience in industry sponsored clinical
Prior experience in project management and/or as a Clinical Research Associate is strongly preferred
Prior experience with medical device studies is strongly preferred
Familiarity with applicable regulations, Good Clinical Practices, and industry standards governing clinical research and the protection of human subjects
Strong critical thinking and discretionary decision-making skills
Strong organizational, analytical, and time-management skills
Ability to multi-task and prioritize autonomously
Excellent written & oral communication skills
Ability and willingness to travel (up to 50%)

Responsibilities

Leading the day-to-day operations of assigned clinical studies
Serving as the study manager and primary point of contact for assigned clinical studies and managing clinical vendors such as Contract Research Organizations
Representing Clinical Operations and providing subject matter expertise on cross-functional multi-disciplinary project teams
Leading the identification, selection, and management of clinical study sites
Leading the identification, selection, and management of associated clinical vendors, such as Contract Research Organizations, through applicable internal approvals
Leading the development of clinical study protocols and investigational plans, case report forms and other study-specific documents (e.g., monitoring report templates, informed consent forms, monitoring plans; study guides; presentations/training materials; clinical study reports, etc.)
Driving recruitment and operational excellence to ensure data quality and integrity and to ensure compliance with the study protocol, investigational plan, applicable regulatory requirements, and Good Clinical Practices
Coordinating communications with study investigators and site personnel (e.g., developing study newsletters, etc.)
Developing and managing study budgets, project timelines, progress reports, and corrective action plans to ensure that clinical studies achieve company objectives on-time and within budget
Managing, mentoring, and/or training Clinical Research Associates
Assisting with the development of effective Standard Operating Procedures, work instructions, and job aides for use by the clinical research team
Assisting in planning and execution of investigator meetings
Coordinating the identification and selection of clinical vendors
Monitoring clinical trials through all phases
Reading and critically interpreting relevant literature and serving as a resource for clinical knowledge of assigned therapeutic areas
Ensuring timely subject recruitment and smooth implementation of studies by leading, guiding and motivating site personnel to achieve study goals
Assisting with review, routing, and approval of clinical trial agreements and site activation documentation
Presenting study information and data at investigator meetings, team meetings, and executive leadership reviews
Assisting with preparation of Ethics Committee submissions and notifications/submissions to federal and state regulatory authorities
Collaborating with other Axogen departments as applicable (ex: Clinical Sciences, Marketing, Medical Affairs, etc)
Participating in internal and external audits