Duties and Responsibilities:

• Primary performs the role of Clinical Study Lead, and may perform other roles including Clinical Operations Lead.
• Manage low complexity, non-regulated studies (Investigator Initiated, Registries, or company sponsored Postmarket studies).
• Assist with high complexity or regulated studies (IDE, HDE, Post-Approval, 522), and may manage components.
• Complete required templates and documents, and maintain records related to assigned projects.
• Develops an understanding of the roles and responsibilities of other functional areas including Franchise Clinical Operations, Biostatistics and Data Management, Medical Affairs, Evidence Based Medicine, Regulatory Affairs, Legal, Health Care Compliance, Research and Development, and Marketing.
• Complete clinical tasks related to product development activities; may participate in Project Core Team (PCT).
• Assist in front end activities related to clinical feasibility, including literature reviews.
• Assist with the development of materials to be used by Clinical Operations for study execution (Investigator Brochures, training materials, etc.).
• Manage and monitor the progress of assigned Investigator Initiated Studies, including interacting with the primary Investigator and site staff, verifying milestones, tracking budgets, and generating evidence according to agreements.
• Verify milestones and track payments for assigned Operating Company-managed projects.
• Collaborate with Franchise Clinical Operations, Biostatistics and Data Management, and other functions to ensure study progress for assigned projects, and issues are identified and communicated to leaders, as well as, ensure site staff, including primary Investigators and study coordinators, are appropriately trained and conducting the study according to the protocol and study agreements.
• Responsible for technical writing, which may include drafting of components of protocols, study reports, reports to regulatory bodies, or summaries of clinical literature.
• Support the implementation of new clinical systems/processes.
• Keep management informed of key developments and issues that impact clinical strategy and portfolio management.
• Ensure the completion of required templates and documents, and maintenance of records.
• Develop high standards of critical thinking, analysis, collaboration, and communication for the advancement of clinical programs. Develop an understanding of the Operating Company product portfolio and pipeline.
• May assist in determining fair market value (FMV) and planning for study budgets.
• May assist with preparations for Clinical Research Committee and Protocol Review Committee meetings.
• May assist with the review clinical information required for periodic safety and post-market surveillance reviews in collaboration with Medical Affairs.
• May be involved in other tasks to support clinical research activities or Operating Company as needed.

Job Profile:

Education Requirements:

• BS/BA or equivalent, preferably in Life Sciences, Biomedical Engineering, or related field required.
• Advanced medical science or medical degree is desirable.

Experience:

• Desirable minimum durations of relevant experience: BSc with 3 years; Masters with 1 year; PhD/MD/PharmD with 0 to 1 year.
• Previous clinical research or related technical experience required.
• Experience with medical devices is desirable.
• Certification from a recognized professional organization (i.e., CCRA, RAC, CDE) is desirable

Other Requirements:

· Application of scientific research principles

· Understanding of Good Clinical Practices

· Demonstrated competencies in the following areas are required:

o Leadership in a professional and ethical manner

o Presentation skills and influencing of others

o Written and oral communication skills

o Technical writing

o Project management skills

· Ability to travel domestically and internationally up to 20%.