Clinical Data Management Manager

Integra LifeSciences•Princeton, NJ

6d•$109,250 - $149,500•Hybrid

About The Position

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Requirements

Bachelor’s degree in life sciences, data Science or related field.
Minimum of 10 years of progressive experience in clinical data management within pharmaceutical, biotechnology, medical device/diagnostic, or CRO environments.
Demonstrated experience leading multiple clinical studies, mentoring staff and managing vendors.
Advanced proficiency in EDC systems and clinical data processes.
Strong leadership, communication, and stakeholder management skills.
Proven ability to manage multiple priorities and take full ownership of deliverables.
Proven ability to proactively identify, analyze, and resolve complex data‑related issues using structured problem‑solving approaches and sound judgment.

Nice To Haves

Relevant certifications such as CCDM are a plus.

Responsibilities

Lead and oversee end-to-end clinical data management activities across assigned studies and projects.
Serve as data management subject matter expert, providing strategic input into study planning, execution, and risk mitigation.
Drive continuous improvement initiatives, contributing to GSOPs and work instructions development and data management strategy.
Provide strategic input in database design and direct data review/ data cleaning, query management and database lock activities, ensuring alignment with study objectives and timelines.
Ensure compliance with GCP, internal GSOPs and regulatory requirements.
Oversee vendor performance, acting as escalation point for quality, timeline and scope issues.
Use procedural expertise and analytical skills to represent data management in cross-functional forums with clinical study teams, Biostatistics, Medical Affairs, and external partners to ensure effectiveness of data management deliverables such as database design, overall data quality, and data outputs for analysis.
Act as a formal resource for onboarding, training and mentorship of data management staff to build team capabilities and succession readiness.
Foster a collaborative, accountable, high-performance team culture.
Accountable for Clinical Data Management system validation and eTMF filing, ensuring readiness, compliance, and inspection preparedness.