Clinical Study Manager

Axogen is hiring for a Clinical Study Manager in Tampa or Alachua, FL!

Job Summary of the Clinical Study Manager

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 of the Clinical Study Manager

• 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 research. 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 of the Clinical Study Manager

The specific duties of the Clinical Study Manager include but are not limited to:

• 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

Location

13631 Progress Blvd #400, Alachua, FL 32615

OR

111 West Oak Avenue, Tampa, FL  33602

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