Clinical Affairs Lead - In Vitro Diagnostics (US-REMOTE)

EUROIMMUN US (a Revvity Company), is one of the leading manufacturers of medical laboratory diagnostics worldwide. EUROIMMUN US stands for innovation and is dedicated to improving the science of diagnostics and people's lives worldwide. Our extensive product portfolio and innovative technologies are designed to provide quick, accurate, and reliable diagnoses. More than 3,300 employees in 17 countries develop, produce, and sell test systems to support the diagnosis of diseases, as well as software and automation solutions for the performance and evaluation of these tests. Laboratories in over 140 countries use our assays and automation for autoimmune, infectious disease, allergy, antigen, and molecular testing. EUROIMMUN US proudly prioritizes a people-centered culture, securing a spot among New Jersey's 2023 Top Places to Work.

JOB SUMMARY

EUROIMMUN US is seeking a highly motivated and experienced Clinical Affairs Lead to join the exciting area of in vitro diagnostic products including reagents and automated instruments that span various disease portfolios such as autoimmune, infectious disease, allergy, antigen detection, and molecular diagnostics. The Clinical Affairs Lead is responsible for leading, planning, execution, and tactical support of clinical research and investigational affairs while assuring full GCP compliance with worldwide standards and regulations. You will work with the Associate Director of Clinical Affairs to execute clinical trials, and partner with Clinical Research Organizations (CROs) to ensure good clinical practice.

The Clinical Affairs Lead will provide tactical support throughout the development and execution of clinical trials to support clinical evidence generation for regulatory submissions across the organization. You will lead Clinical operations and work with key stakeholders for the planning, conduct, and execution of Clinical studies. During Clinical trials, the Clinical Affairs Lead will be responsible for driving the progress of the trial during site selection, site start-up, site activation, site monitoring, and site close out. Will oversee Clinical research activities, study coordination, GCP compliance, clinical related data management / biostatistics, and sample acquisition. Additional responsibilities may include protocol review, preparation of clinical sections of key regulatory documents, and IRBs and Ethics committee’s submissions. Must be comfortable working in a fast-paced environment and flexible to changing priorities. Must be a self-starter and able to work independently. Must possess effective time management, organizational and interpersonal skills, conflict management, problem-solving skills and a high sense of accountability. Must be able to set priorities and handle multiple tasks simultaneously with a high quality and compliance mindset.

ESSENTIAL FUNCTIONS

• Oversee the management, planning, execution, and monitoring of clinical studies to ensure they meet targeted timelines, established project requirements, ICH GCP compliance, and regulatory guidelines.
• Manage all aspects of Clinical study execution including site selection, qualification, initiation, monitoring, close out, TMF completion, IRB submission etc.) from concept through clinical study report completion.
• Lead the development of study-related documents, including informed consent documents, study manuals and plans, trial master files, case report forms, etc.
• Interface with site coordinators, investigators, and other field personnel regarding study devices, clinical protocols and sample testing.
• Maintain Clinical Documentation including drafting and/or reviewing of SOPs and Work Instructions.
• Facilitate internal and external Clinical Studies planning meetings including tracking study progress and providing regular status reports.
• Collaborate with cross functional teams during the study planning, coordination, and management phases.
• Collaborate with data management for data collection methods, database best practices, database user acceptance testing, and database lock.
• Ensuring collection of study data is accurate, complete, and conforms to regulatory submission data standards and protocol requirements.
• Maintain in depth knowledge of protocol and conduct literature reviews to stay updated on relevant scientific/clinical knowledge and/or to determine gap analysis.
• Oversee external partners/CRO/vendors, provide guidance for all activities assigned and ensure all vendors meet project milestones according to budget and timeline.
• Manage vendor and site budget and contract negotiations, review invoices and liaise with legal for contracts and finance for payments.
• Ensure inspection readiness of all assigned Clinical studies and participate in internal and external audits.
• Perform other duties as assigned.

BASIC QUALIFICATIONS

• Bachelor's or Master's degree in life sciences discipline and five years of IVD medical device Clinical Affairs experience.
• Well versed in FDA regulations, standards, and guidance governing the conduct of Clinical studies.
• Ability to travel up to 40%, both domestic and international.

PREFERRED QUALIFICATIONS

• Experience in managing a Clinical trial from start to finish; including protocol review, ICF generation, study start up, contract and budget negotiation, vendor management, CRF design, trial management and study close out.
• Ability to identify potential study risks that may impact the studies (e.g., study data, ethics, and GCP guidelines) and provide risk mitigation solutions.
• Excellent cross functional collaboration and interpersonal skills.
• Demonstrated ability to manage multiple, complex projects.
• Effective verbal and written communications skills.
• Strong presentation and good documentation practice skills.
• Strong work ethic and dedication to producing quality work.
• Experience in leading Clinical studies to support regulatory submissions IDE, 510(k), De Novo, PMA, or PMA supplement submissions.
• Experience in interacting with global cross functional teams.
• Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
• Established network of sample acquisition vendors, CROs, investigators, or KOLs.
• Ability to work in a fast-paced team environment with demonstrated problem solving, strategic thinking and analytical skills.
• Self-motivated, self-directed, detail and action oriented.
• Clinical Research certification (SOCRA, ACRP).

DIRECT REPORTS

• There are no direct reports in this role.

COMPENSATION RANGE

The base salary range for this full-time position is $87,500 - $159,500/year. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

WHAT DO WE OFFER?

We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

·Medical, Dental, and Vision Insurance Options

·Life and Disability Insurance  

·Paid Time-Off

·Parental Benefits

·401k with Company Match

·Employee Stock Purchase Plan

Learn more about Revvity’s benefits by visiting our Why Revvity page.

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