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 QUALIFICATIONSEducation:
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:
$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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour 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)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
