Job Description
About Scientia Vascular Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
Job Position Summary The Clinical Affairs Manager (hereafter: “CA Manager”) is responsible for generating clinical evidence for regulatory submissions, post market surveillance, and marketing claims along with performing activities necessary to comply with global regulation, primarily in the United States and the European Union. Specifically, the CA Manager will help identify and coordinate clinical needs and run clinical studies, along with working to obtain regulatory approvals for new devices in development and helping to maintain approvals for Scientia Vascular’s portfolio of marketed devices. The CA Manager will also offer guidance generally on clinical and regulatory matters.
Clinical Affairs Primary Responsibilities - Oversee overall strategy and process of compliance and management of clinical evidence generation
- Generate clinical evidence for regulatory submissions, post market surveillance, and marketing claims
- Run clinical studies according to ICH and GCP standards and ensure Scientia is in compliance with regulations for human subject protection
- Coordinate inter-departmentally to understand clinical evidence needs and project scope, lead study design, generate cost proposals and timelines, and manage study execution
- Identify and contract with sites and physicians
- Write protocols, data collection forms/case report forms, consent documents, and other study related documents and route them through the Scientia quality system and IRB review (as necessary)
- Manage external consultants or clinical KOLS to support clinical evidence generation
- Coordinate with external collaborators to design, run, and report on clinical studies
- Set up and maintain a Trial Master File for studies that need it
- Generate training for study personnel and travel to participating sites
- Perform site initiation, monitoring, and close out visits, along with necessary remote monitoring for studies as required
- Write and maintain all Quality System procedures related to clinical evidence generation
- Support and coordinate the preparation and submission of global regulatory filings
- Assist with the maintenance of global product registrations
- Comfortable with communication and interfacing with regulatory authorities
- Review labelling and marketing materials to ensure alignment with current clinical evidence
Requirements/Qualifications - BA/BS degree in Science, Engineering, Math or related field of study or equivalent
- Minimum of 3 years of experience in medical device clinical affairs role
- History of IRB communication, clinical writing (protocol, ICF, CRF, etc.), and TMF creation and maintenance
- Experience performing site qualification, initiation, monitoring, and close out
- History of authoring or contributing to successful 510(k), PMA, and/or CE Mark submissions
- Demonstrated ability to interpret and apply relevant regulations, standards and guidance to ongoing company activities
- Computer proficiency with Adobe, Microsoft Word, and Excel
- Excellent analysis, writing, and communication skills
- Ability to communicate with cross-functional teams
- Demonstrate knowledge of a clinical and regulated environment
- Progressive CA leadership experience, including “hands-on” quality systems development
- Strong background in analyzing and interpreting clinical trial data
Preferred Experience - Experience managing a team of people
- Advanced degree (MS, PhD, or PharmD
- experience contributing to successful regulatory submissions
- Familiarity with risk-based monitoring, adaptive trial design, or decentralized trials
- History of publishing in academic journals
- Ability to understand technical documents and drawings
Key Benefits We Provide - Medical, Dental, Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- Short-Term & Long-Term Disability Insurance (company paid)
- Subscription to Calm.com
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment To Equal Opportunity The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds.
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Job Tags
Holiday work, Contract work, Temporary work, Remote job,