Location: Atlanta, GA or Boston, Ma
Reports to Chief Operating Officer
Position Type: Full Time Employee
Travel Required: ~ 25%
Responsible for the development of all phases of clinical research to meet company objectives, advocacy of clinical evidence through presentations, publications, and speaking bureau events. Manages Clinical Research Associate (CRA) and Clinical Advocacy personnel toward department objectives. Interfaces with customers, key opinion leaders, Engineering, Regulatory, Marketing, and Executive Management. Acts as resource to internal and external customers on clinical issues.
- Will collaborate with Executive Management and Marketing on the creation of strategic map of relevant clinical study evidence by parameter/product.
- Will support Science and Product Development Initiatives by developing clinical study concepts, identifying project sites, developing protocols and performing associated risk analyses, developing study materials, and defining budgets and timelines.
- Development of investigator and patient recruitment strategies including operational feasibility and implementation path; management and communication to the executive team and key stakeholders.
- Management, monitoring and reporting on all clinical study activities to ensure timely completion, regulatory compliance
- Work with investigators to develop a publication plan targeting key scientific meetings and publications to highlight study results
- Participation in and leadership of Key Opinion Leader (KOL) meetings including Global Advisory Board
- Hire, train and manage a team and budget to meet department and company objectives
- 15+ years of progressive experience in clinical research and clinical trial operations, and a minimum of 8 years in a supervisory role managing clinical operations staff.
- BA/BS in life sciences or healthcare field required; advanced degree(s) highly desired. Additional coursework in clinical trial design and implementation desired.
- Industry experience within the medical device fields, with experience in wound healing research highly preferred.
- Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.
- Excellent track record of effective performance in cross-functional environment, including successful relationships with data management, bioinformatics, biostatistics, medical writing, and regulatory affairs.
- People management and team motivation skills to motivate staff and cultivate quality processes.
- Excellent verbal and written communication and presentation skills, interpersonal and negotiation skills, organizational and problem
- Demonstrated, effective planning and project organization skills, including risk assessment, contingency planning and ability to prioritize effectively.