Your role with the company:

•   Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with regulatory policies, Good Clinical Practices, procedures and/or guidelines during clinical trials.

•   Oversee the planning and execution of all phase of clinical studies to ensure that deliverables are completed on time and within budget.

•   Develop an understanding of competitive landscapes for assigned products and therapeutic areas.

•   Develop and execute project plan, manage study time and ensure activities are conducted in order to achieve

  scheduled milestones and goals.

•   Manage and direct consultants/contractors, contract research organizations to ensure that deliverables are completed

  on-time, within budget, and are consistent with the scope of work.

•   Select and Implement clinical systems (eTMF, EDC)

•   Develop and execute enrollment plan(s).

•   Develop and manage study related documents and materials such as investigational plans, case report forms, study

  manuals, monitoring plan, informed consents, recruitment materials, clinicaltrials.gov, and other study related tools.

•   Obtain and reviews all required essential documents necessary for study initiation.

•   Prepare and present project progress reports to keep management and team informed.

•   Assist with data analysis and interpretation of the results.

•   Coordinate the development of clinical abstracts/manuscripts and presentations.

•   Prepare the clinical sections of regulatory submissions and assist regulatory in preparing responses to regulatory

  agencies’ questions regarding the clinical study.

•   Participate in presentation of clinical information to the FDA.

•   Plan investigator and coordinator meetings and prepare and present meeting materials.

•   Functions independently in the field and interacts with all levels of medical and scientific professionals.

•   Suggests and implements improvements for increased departmental efficiency.

•   Develops management and supervisory skills necessary for advancement.

•   Assumes responsibilities of the department manager in their absence.

Desired Profile:

•   B.S. degree in Biology, Chemistry, Nursing or related discipline and a minimum of 8+ years of related work experience

•   Knowledge of aortic arch anatomy, stent grafts and current practices and procedures is desired. Must have class 3 cardiac device experience.

•  Minimal travel, up to 10%

•  Strong knowledge of FDA guidelines and regulations governing conduct of clinical trials

•  PMA and Post Market study experience desired

•   Demonstrated ability to work independently and generate solutions to a wide range of difficult issues

•   Possesses negotiation, diplomacy, team leadership skills and organizational ability

•   Strong organizational skills and attention to detail

•  Ability to handle multiple and shifting priorities in a fast-paced environment