Current Opening: Sr Clinical Trials Manager
We have an exciting opportunity for a Sr. Clinical Trials Manager to join our team! This position is responsible for strategic development, clinical positioning development and tactical execution of key clinical marketing programs to create awareness of the clinical benefits of iovera and support successful clinical implementation. In this role, you will serve as the clinical trial expert providing clinical protocols, tools, and educational programs supporting the adoption of our product(s), establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and provide guidance for ongoing clinical research and clinical trials. This position is responsible for monitoring adherence to protocols and determines study completion.
- Manage the design, management, and evaluation of clinical studies. Oversee the analysis of clinical data.
- Develop and maintain working relationships with CROs, contract clinical support staff, and site investigators and staff.
- Oversee the clinical monitoring duties including study site monitoring and tracking, working with clinicians to ensure adherence to protocol, FDA and GCP guidelines, initiations and close out visits, review case report forms for completeness, legibility and conformity to available source.
- Outline clinical application expansion opportunities, develops and executes an actionable clinical marketing needs assessment.
- Assess customer unmet needs and develop clinical value propositions that align our product with patient care therapies.
- Work cross-functionally to identify clinical claims which will shape product and brand positioning. Build clinical messaging language with claims supported by the evidence-based research.
- Develop marketing strategy and tactics for clinical programs with input from customer, the field and marketing teams.
- Ensure maximum value is derived by driving/developing/fostering influential and meaningful case studies, publications, and presentations of resulting clinical information.
- Advise on medical and scientific marketing/product materials in conjunction with product marketing; provide clinical and customer input to internal teams as it relates to the use of our product and positioning with key customer groups.
- Develop and manage relationships with relevant key societies and organizations that will enhance our understanding of the healthcare environment and key initiatives.
- Manage the Clinical Research budget to efficiently and effectively achieve corporate goals
- Bachelor’s degree in related field; masters’ preferred with at least 7+ years’ experience in medical device
- Must have clinical background
- Have prior training and experience with Good Clinical Practice (GCP)
- Strong project planning, leadership, negotiation and presentation skills
- Desire to work in an open, collaborative, and fast-paced environment
- Ability to develop creative solutions to overcome challenges
- Previous start-up experience a plus
- Must be available to travel 30-40% of the time
- Superior written/verbal communication, teamwork and interpersonal skills to work across multiple constituents.
Duties of this job may involve standing and/or walking, but for most part sitting for extended periods of time. Duties also involve daily keyboard data entry.
If you are interested in joining our team, please send your resume to firstname.lastname@example.org.