Senior opportunity leading Clinical Operations at a company developing devices that deliver critical therapies to the cardiopulmonary system of newborns. The experienced Clinical Operations manager will be responsible for ensuring global clinical trial activities and deliverables are completed on-time, within budget, in a dynamic environment. You would have a significant impact in this well-funded, early stage firm is developing with a team of successful, industry experienced colleagues.
- Provide leadership and expert oversight regarding logistics of clinical studies including project planning, budget, resource management and contract research organization management.
- Act as a cross functional liaison to ensure study plan aligns with business development strategies.
- Contribute to product and clinical development plans.
- Provide strategic regulatory input to overall development plans.
- Ensure that the conduct of clinical trials comply with ICH, GCP and other applicable regulatory requirements, and reported trial data are accurate, complete, verifiable from source documentation.
- Be the contact for escalation for management of vendors such as contract research organizations, central laboratories, and other specialty service providers, as needed.
- Oversee study management, including, budget and contract negotiations, issue escalation.
- Represent the company with a high level of integrity and professionalism, adhere to its policies and support management decisions and goals in a positive, professional manner.
- Minimum of BS in nursing or other life sciences disciplines.
- 8+ years of experience leading multiple global cross-functional clinical studies and vendors (includes First-in-Human, Phase 1b, proof-of-concept, dose-ranging, drug-drug interaction, special populations, and other Phase 2 trials), as well as experience in pre-clinical development.
- Experience with Phase 3/Pivotal registration trials is highly desirable.
- Respiratory and/or cardiovascular device or drug experience is a plus.
- Early development experience with therapeutic medical devices is highly desired.
- An understanding of and experience in the medical device, drug, or combinatorial device development process, including clinical program management, drug safety surveillance and reporting requirements, global regulatory reporting requirements, clinical study report requirements.
- Thorough working knowledge of medical terminology.
- Able to recognize need(s), find solutions and take initiative to address them proactively.
- Direct supervisory experience, strong organizational, planning, and time management skills.
- Extensive computer skills and use of Microsoft Office applications, including proficiency in MS Project .
- Experience influencing and negotiating to achieve team delivery; flexible, proactive and solution-focused.
- High level of initiative and ability to work independently; self-motivated and achievement driven.
- Able to distill complex information from multiple sources and draw meaningful conclusions and insights.
- Highly effective verbal, presentation and written communication skills for various audiences.
- Ability to travel (domestically and internationally) up to 25%.