Clinical Data Management Manager

INTEGRA LIFESCIENCES CORP; Kingston (NJ); Hybrid; USD 109,250 - 149,500; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

Integra LifeSciences in Princeton, NJ, is seeking an experienced leader to oversee end-to-end clinical data management across studies. You will guide study planning, data review, and regulatory compliance, while mentoring staff and coordinating with cross-functional teams.

Bring 10+ years in CDM, strong EDC/eTMF experience (Veeva preferred), and a track record of delivering data quality on time in regulated environments.

Qualifications

• Education: Bachelor’s degree in life sciences, data Science or related field.
• Minimum of 10 years in clinical data management across pharma/biotech/CRO environments.
• Experience leading multiple studies, mentoring staff and managing vendors.

Responsibilities

• Lead end-to-end clinical data management activities across studies and projects.
• Provide strategic input into study planning, execution and risk mitigation.
• Drive improvements and contribute to data management strategy and GSOPs.
• Oversee database design, data review/cleaning, query management and database lock.
• Ensure compliance with GCP, GSOPs and regulatory requirements.
• Oversee vendor performance and act as escalation point for issues.
• Represent data management in cross-functional forums to ensure data quality and outputs.
• Mentor data management staff and build team capabilities.
• Foster a collaborative, high-performance team culture.
• Accountable for CDM system validation and eTMF filing readiness.

Skills

Leadership

Stakeholder management

Mentoring staff

Problem solving

Data quality focus

Education

Bachelor's degree in life sciences or related field

Tools

EDC systems

eTMF platforms

Veeva CDMS

Veeva eTMF

Job description

Changing lives. Building Careers. 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.

KEY 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.

REQUIRED SKILLS & MINIMUM QUALIFICATIONS

• Education: Bachelor’s degree in life sciences, data Science or related field.
• Certifications: Relevant certifications such as CCDM are a plus.
• Experience: Minimum of 10 years of progressive experience in clinical data management within pharmaceutical, biotechnology, medical device/diagnostic, or CRO environments.
• Relevant skills: 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.
• Tools And Equipment Used: Experience using Clinical Data Management systems, including Electronic Data Capture (EDC) and electronic Trial Master File (eTMF) platforms; Veeva CDMS and Veeva eTMF experience preferred.

Additional Information

This is currently a hybrid role, and the ideal candidate will be based out of Princeton, NJ. The hybrid schedule requires in-office presence on Tuesdays, Wednesdays, and Thursdays, with the option to work remotely on Mondays and Fridays.

Salary Pay Range

Salary Pay Range: $109,250.00 - $149,500.00 USD

Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.