Clinical Data Management LeaderJoining 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 ResponsibilitiesLead 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 strategyProvide 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 deliverablesProven 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.Salary Pay Range:$109,250.00 - $149,500.00 USD SalaryOur 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.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 careers@integralife.com.
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