Senior Clinical Data Manager
Are you ready to make an impact in the fight against blindness? Join a cutting-edge biopharmaceutical company dedicated to developing transformative therapies for retinal diseases. We are seeking an experienced senior CDM to ensure the integrity, compliance, and readiness of clinical trial data that drives regulatory success and improves patient outcomes worldwide.
Key Responsibilities
- Lead study-level data management activities for clinical trials, ensuring timely and accurate deliverables.
- Design, develop, and validate clinical trial databases and eCRFs to support robust data collection.
- Oversee data cleaning, query resolution, and preparation of submission-ready datasets for global regulatory filings.
- Manage relationships with CROs and external vendors, monitoring timelines and quality standards.
- Collaborate with cross-functional teams-Clinical Operations, Biostatistics, Regulatory Affairs, and IT-to ensure seamless data integration and reporting.
- Maintain compliance with GCP, FDA, EMA, and industry standards; support audit and inspection readiness.
- Drive continuous improvement through implementation and optimization of clinical data systems and tools.
Qualifications
- Bachelor's degree in Life Sciences, Data Science, Computer Science, or related field.
- 7+ years of clinical data management experience within biotech, pharma, or CRO environments.
- Proven expertise in managing study-level data activities and vendor oversight.
- Proficiency with EDC platforms (e.g., Medidata RAVE, Oracle Clinical, Veeva) and CDISC/SDTM standards.
- Experience supporting regulatory submissions (NDA, BLA, MAA) is a strong plus.
- Excellent problem-solving, organizational, and communication skills.
Preferred Skills
- Hands-on experience managing CROs and service providers.
- Prior ophthalmology experience is highly desirable.
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