Sr. Clinical Lead

Ascensia Diabetes Care • Parsippany-Troy Hills, 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. Your expertise will directly influence product success and patient safety by shaping Clinical and Performance Evaluation Reports, guiding cross-functional teams, and engaging with regulatory authorities. Alongside this, you will 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.
• 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.
• 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.
• Plan and continuously gather, analyze, and assess clinical data to demonstrate safety and performance.
• Manage, develop, and maintain Formulate and structure Compiling, generating, and documenting reports.
• Coordinate cross-functional teams (R&D, Regulatory, Quality) to develop and execute Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs).
• Develop Post-Market Surveillance (PMS) Plan and Reports.
• Proactively monitor the device's performance in the real world after it has been placed on the market.
• Generate 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.
• Collaborate with regulatory, quality, and R&D teams to ensure timely and compliant product lifecycle management.
• Oversee risk management activities, ensuring integration of clinical data into benefit-risk assessments.
• Provide 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.
• Implement eCRF design and edit specifications including derivations for all assigned studies.
• 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

• Career Level: Senior