Clinical Affairs Manager
Clinical Affairs Manager
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Salary Not Disclosed
1 Vacancy
Job Description
About ScientiaVascular:
Our mission is to save lives. Scientia Vascular is aleading innovator and manufacturer of endovascular medical devices. We usemicromachining and microfabrication processes to manufacture products thatprovide physicians with enhanced performance for optimal outcomes for theirpatients.
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 Vasculars portfolio of marketed devices. The CA Manager will also offer guidance generally on clinical and regulatory matters.
Primary Responsibilities
Clinical Affairs:
- 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 interdepartmentally 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 crossfunctional teams
- Demonstrate knowledge of a clinical and regulated environment
- Progressive CA leadership experience including handson 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 riskbased monitoring adaptive trial design or decentralized trials
- History of publishing in academic journals
- Ability to understand technical documents and drawings
Key benefits weprovide:
- 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)
- ShortTerm & LongTerm Disability Insurance (company paid)
- Subscription to
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment toEqual Opportunity:
The Scientia Vascular culture iscentered on the principals of equal opportunity for all employees. Consistentwith our culture all qualified applicants will receive consideration foremployment without regard to race color religion gender gender identity orexpression family status marital status sexual orientation national origingenetics disability age or veteran status or any other nonmerit based orlegally protected grounds.
Visit our website and learn more about usat.
Required Experience:
Manager
Employment Type
Full Time
