Principal Clinical Data Manager

You will make an impact:

Highly skilled and seasoned Principal Clinical Data Manager with extensive experience in the management and oversight of clinical data throughout the entire data lifecycle. Proven track record of successful leadership in designing, implementing, and managing data management strategies for complex clinical trials in adherence to industry standards and regulatory requirements. Strong leader effective in managing and fostering cross-functional collaboration among clinical operations, biostatistics, and programming teams to achieve seamless integration of data management activities to drive operational efficiencies and meet project timelines. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

Your day to day:

• Primary representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope
• Function as DM subject matter expert providing guidance on data management best practices, technology, and solutions
• Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management
• Define specifications and collaborate with technical team on configuration of elluminate for data cleaning strategy and oversight activities
• Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate modules
• Perform quality oversight and data trending via elluminate reporting and analytics to identify risks and develop mitigation and data cleaning strategies
• Collaborate with technical and engineering teams on tech enabled solutions in areas for process and efficiency improvement
• Collaborate with functional managers and training team to deliver training.
• Other duties as assigned

Qualifications:

• Bachelor’s degree or higher (master’s in science preferred) in relevant health science or professional qualification in a relevant scientific/technical discipline 10+ years’ experience in Pharmaceutical/Biotechnology industry with Clinical Data Management or equivalent consulting role preferred
• CCDM Certification preferred
• Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. Prefer experience with agile and six sigma methodologies
• Strong consulting and client relationship management skills
• Strong analytical and strategic thinking skills
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Excellent collaborative skills
• Demonstrated command of the English language with proficiency in both verbal and written communication
• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Proficient with EDC and Clinical Data Management Systems
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred)
• Experience with RBQM methodology preferred
• Exposure to CDISC guidelines and standards