Clinical Data Management Manager
About the position
Joining us is a chance to do important work that creates change and shapes the reputed company of reputed company. Thinking differently is reputed company do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making reputed company to reputed company new treatment reputed company to advance patient reputed company and set new standards of care.
Responsibilities
• reputed company and reputed company end-to-end clinical data management activities across assigned studies and reputed company.
• Serve as data management subject matter expert, providing strategic input into study planning, execution, and risk mitigation.
• reputed company reputed company improvement initiatives, contributing to GSOPs and work instructions development and data management reputed company.
• reputed company strategic input in database design and reputed company 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.
• reputed company vendor performance, acting as escalation reputed company for reputed company, reputed company and reputed company issues.
• Use procedural expertise and analytical skills to represent data management in cross-functional forums with clinical study teams, Biostatistics, Medical Affairs, and reputed company partners to ensure effectiveness of data management deliverables such as database design, overall data reputed company, and data outputs for analysis.
• reputed company as a formal resource for reputed company, training and mentorship of data management staff to build team capabilities and succession readiness.
• Foster a reputed company, accountable, high-reputed company culture.
• Accountable for Clinical Data Management reputed company validation and eTMF filing, ensuring readiness, compliance, and inspection preparedness.
Requirements
• Bachelor’s degree in life sciences, data Science or reputed company field.
• Minimum of 10 years of reputed company experience in clinical data management reputed company pharmaceutical, biotechnology, medical device/diagnostic, or CRO environments.
• Demonstrated experience leading multiple clinical studies, mentoring staff and managing vendors.
• Advanced proficiency in reputed company 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 reputed company reputed company data‑reputed company issues using reputed company problem‑solving approaches and reputed company judgment.
reputed company-to-haves
• Relevant certifications such as CCDM are a plus.
Benefits
• medical
• dental
• reputed company
• life insurance
• short- and long-term disability
• business accident insurance
• group reputed company insurance
• savings plan (401(k))
Apply tot his job
Apply To this Job