Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.  

 

We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.  

 

People – We win as a team.  

Customer – We deliver customer-centric solutions.  

Continuous Learning – We learn and always aim to be better.  

Innovation – We innovate every day.  

Results – Results matter for all of us. 

As a Senior Manager, Clinical, you’ll drive the scientific and clinical success of cutting-edge medical devices. You will lead the charge in demonstrating the safety, effectiveness, and real-world performance of both current and future products. You'll manage end-to-end clinical operations—from shaping strategy to executing studies—ensuring our innovations meet global regulatory standards and improve lives.

Location: Winston-Salem, North Carolina (Onsite)

ATTENTION please mail resumes to:

New Erie Scientific LLC,
Attn: A. Iczkovitz

20 Post Rd, Portsmouth, NH 03801

What you will be doing:

Manage all operational aspects of establishing scientific validity and clinical performance of all medical devices marketed and under current development.Provide leadership, project management, and program oversight to meet general safety and performance requirements for medical devices.Plan and conduct high quality clinical trials concurrently in accordance with relevant guideline and regulations in support of regulatory authority submissions.Oversee, lead, and manage cross-functional resources and/or external service providers (including clinical operations, CRO, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.Establish and ensure clinical trial team and clinical trial sites are properly trained and in compliance with protocols.Perform site monitoring with field team.Facilitate all start-up activities including but not limited to investigational site contracts, investigational site, and ethics committee submissions.Facilitate confidentiality agreements.Negotiate study agreements and budgets with sites and external vendors.Write, review, recommend, and/or approve clinical performance project deliverables.Work with appropriate team members to ensure that all related documentation is current and on-file at required locations throughout trial conduct.Monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast budgetary requirements based on scope of work.Develop and leverage technology solutions that support clinical trials operations and allow for visibility into trial quality and risk management.Develop appropriate SOPs and other template documents for standardization of processes to ensure quality. International and/or domestic travel may be required.

Skills you will need:

Master’s degree or foreign equivalent in an engineering or medical related field.3+ years of experience as a Manager of a Clinical Research & Development group.Experience must include project management of clinical trials pertaining to medical devices and/or technology.International and/or domestic travel may be required.

RATE OF PAY:  $182,582 per year

TO ALL RECRUITMENT AGENCIES:  Epredia does not accept unsolicited third-party resumes.
 

Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.