Clinical Research Manager.
The Clinical Research Manager position requires a strong background in the execution and oversight of clinical research studies. The qualified candidate is responsible for assisting with the development of clinical programs and all aspects of clinical study execution, including clinical site initiation and maintenance, and collection of high quality clinical data to support development and marketing efforts for Aziyo products. The company currently has post market clinical programs in a number of therapeutic areas including cardiovascular and orthopedics.
Position reports to the Associate Director of Clinical Operations.
Essential Duties & Responsibilities
- Design clinical protocols and effective case report forms to carry out the execution of corporate development plans for Aziyo products.
- Compile regulatory submission documentation and maintain organized regulatory and clinical files.
- Develop clinical study plans and timelines for tracking clinical programs and clinical site performance.
- Perform clinical site selection, qualification, initiation, and training.
- Develop and generate materials and tools to support clinical site enrollment and subject retention efforts.
- Perform clinical data monitoring activities to ensure all data collected is accurate and complete.
- Maintain clinical databases/systems, and other ad hoc tasks associated with clinical research as required.
- Ensure compliance with Good Clinical Practices, all applicable company guidelines, SOPs, laws, and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
Bachelor’s degree from an accredited college or university or an equivalent combination of education and work experience required.
Experience and Skills
Work Experience Required:
- Minimum of 5 years of progressive clinical experience and responsibility in the medical device or biotech/pharmaceutical industry.
- Successful experience in clinical trial initiation, oversight, activities and in working with clinical sites.
- Excellent customer-facing skills. Ability to interact with all levels of study site personnel in an effective manner to accomplish goals while also representing Aziyo is a positive way.
- Strong organizational and communication skills, as well as attention to detail and the ability to manage multiple priorities and produce accurate and timely work in a highly-regulated environment required.
- Experience at working in fast-paced, project team environments.
- Experience in the use of electronic data capture systems.
- Proficient in MS Office applications (Word, Excel, PowerPoint, Outlook, etc.).
- Ability/willingness to travel (up to 30%)