Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager overseeing data management processes for Multifocal Motor Neuropathy and CIDP clinical trials. Ensuring high quality and regulatory compliant data throughout the trial lifecycle.
Responsibilities:
- Play a critical role within the team leading data management processes for clinical trials.
- Oversee all clinical data management and related deliverables from start-up through close out.
- Independently support assigned active programs to ensure complete, accurate, high quality and regulatory compliant data.
- Support data aggregation and analysis in the advancement of patient care.
- Responsible for relationships with Data Management partners (eg, CROs and vendors).
- Oversight of outsourced study-related DM activities including CRF design, data collection, edit checks and listings reviews, data reconciliation, medical coding, UAT testing, database lock and archival of DM documents.
- Accountable for ensuring data quality and timeliness of DM deliverables are met and align with company goals.
- Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements.
Requirements:
- BS in relevant discipline. Life Sciences experience is a plus.
- Strong understanding of DM related systems, technologies and standards including data analytics platforms.
- Comprehensive knowledge of drug development and clinical research processes, GCP guidelines and regulations related to clinical data management.
- Self-motivated and able to work autonomously as well as take direction and work within a high-functioning and collaborative team environment.
- Detail-oriented with strong verbal and written communication skills.
- Ability to build relationships internally and with external partners.
- Highest levels of professionalism, confidence, personal values and ethical standards.
Benefits:
- We are open to you working remotely.
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