Sr. Clinical Lead

Ascensia Diabetes Care • Parsippany, NJ

1d

About The Position

As the Sr. Clinical Lead, you will drive end-to-end clinical evaluation and post-market strategies in alignment with IVDR and MDR requirements. From shaping Clinical and Performance Evaluation Reports to guiding cross-functional teams and engaging with regulatory authorities, your expertise will directly influence product success and patient safety. Alongside this, you’ll play a hands-on role in advancing clinical data infrastructure through Electronic Data Capture (EDC) development, ensuring high-quality, reliable data across studies. This is an opportunity to combine strategic oversight with technical depth—partnering across Regulatory, Quality, and R&D to deliver compliant, data-driven outcomes that support the full product lifecycle.

Requirements

• Bachelor’s degree or higher-level degree in biological science(s), Statistics, Computer Science or a scientific/quantitative/computer-oriented field.
• At least 3-6 years related experience with clinical IVDR/ MDR compliance including and 1-2 years with direct experience with Electronic Data Capture (EDC) design and deployment.
• A strong background in relevant medical or scientific fields (e.g., medicine, pharmacy, biology, engineering, or a related scientific discipline).
• Previous experience in IVDR./ MDR clinical specialist role.
• Comprehensive understanding of the EU Medical Device Regulation (MDR) (EU 2017/745) and In Vitro Diagnostic Regulation (IVDR) (EU 2017/746), as well as related guidance documents (e.g., MDCG, MEDDEV) and standards (e.g., ISO 13485, ISO 14155, ISO 14971).
• Experience with and knowledge of clinical trial data management process is required.
• Experience with clinical data management software.

Nice To Haves

• Experience with Greenlight Guru Clinical (GGC) is preferred.

Responsibilities

• Develop and manage Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) to support CE marking and regulatory submissions.
• Planning and continuous process to gather, analyze, and assess clinical data to demonstrate safety and performance.
• Manage Develop and maintain Formulate and structure Compiling, generating, and documenting reports
• Coordinated cross-functional teams (R&D, Regulatory, Quality) to develop and execute Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
• Post-Market Surveillance (PMS) Plan and Reports: A plan for proactively monitoring the device's performance in the real world after it has been placed on the market. Regular reports that document findings, such as adverse events and Field Safety Corrective Actions (FSCAs), and communicate them to regulators.
• Lead representative for European Database (EUDAMED).
• Author and manage relevant standard SOP’s including periodic review ensuring clinical compliance.
• Support Clinical Affairs in development of Clinical Investigation Plans outlining the plan for conducting a clinical investigation, which may be required to generate the necessary clinical data for the CER/PER.
• Manage clinical data collection, analysis, and interpretation to support CE marking and post-market surveillance activities.
• Oversee risk management and gap assessments to ensure product safety, performance, and regulatory readiness.
• Liaison with notified bodies and regulatory authorities to address queries and provide documentation.
• Maintain up-to-date knowledge of evolving EU regulatory frameworks to guide strategic clinical planning.
• Direct end-to-end clinical performance evaluation and post-market clinical follow-up (PMCF) for medical devices and IVD products.
• Support cross-functional teams in designing, executing, and reporting clinical investigations in alignment with ISO 14155 and regulatory guidelines.
• Collaborated with regulatory, quality, and R&D teams to ensure timely and compliant product lifecycle management.
• Oversaw risk management activities, ensuring integration of clinical data into benefit-risk assessments.
• Provided training and guidance on IVDR/MDR clinical requirements to internal stakeholders.
• Represent as Subject Matter Expert for Internal and External Audits
• Coordinate eCRF development and maintenance across clinical trial projects for consistency
• Provide eCRF and eCRF design analysis and recommendations to ensure best practices are instituted.
• Support maintenance of EDC related SOPs and work instructions.
• Apply expertise in the software tools ADC is using to create eCRFs and collaborate on training for end-users with software vendors and CROs counterparts.
• The eCRF components will include forms, dictionaries, edits, database, reports, and custom functions.
• Implement eCRF design and edit specifications including derivations for all assigned studies.
• Ensure they are complete and comprehensive and include custom functions prior to building the eCRF.
• Develop study level eCRFs including programming the edits including simple custom functions.
• Ensure that all eCRF testing is completed and documented.
• Provide input if eCRFs are audited.
• Maintain assigned eCRFs including making updates to deployed eCRFs and ensuring that all updates are fully tested before deployed.
• Provide study specific eCRF training when assigned.
• Solve eCRF design issues for assigned studies.
• Archive eCRFs and eCRFs as defined by SOPs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior