Principal Clinical Data Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Serve as the primary liaison for eClinical Solutions and sponsor data management interactions, ensuring adherence to the eClinical Solutions data management process while meeting quality standards and timelines within the approved scope.

• Act as a subject matter expert in data management, offering insights on best practices, technologies, and solutions.

• Outline study requirements, including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, and Query Management.

• Establish specifications and work in conjunction with the technical team to configure elluminate® for data cleaning strategies and oversight activities.

• Conduct Quality Control on deliverables produced by team members, which includes study documents, program specifications, report specifications, and elluminate® modules.

• Perform quality oversight and data trending through elluminate® reporting and analytics to identify risks and develop mitigation and data cleaning strategies.

• Collaborate with technical and engineering teams to implement tech-enabled solutions aimed at enhancing processes and efficiency.

• Partner with functional managers and the training team to facilitate training sessions.

• Undertake additional duties as assigned.

⛳️ Requirements

• A Bachelor’s degree or higher (master’s in science preferred) in a relevant health science or a professional qualification in a scientific/technical discipline is preferred.

• Over 10 years of experience in the Pharmaceutical/Biotechnology industry in Clinical Data Management or an equivalent consulting role is preferred.

• CCDM Certification is preferred.

• Strong project management experience and leadership skills in project teams, including work planning, delegation, and resolving complex issues; experience with agile and six sigma methodologies is preferred.

• Excellent consulting and client relationship management skills.

• Strong analytical and strategic thinking abilities.

• Detail-oriented with the capacity to multitask, along with strong prioritization, planning, and organizational skills.

• Exceptional collaborative skills.

• Proven command of the English language, with proficiency in both verbal and written communication.

• Proficient in Microsoft Office Applications, particularly MS Project and MS Excel.

• Familiarity with ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.

• Proficient in EDC and Clinical Data Management Systems.

• Experience with Cloud SaaS platforms is preferred.

• Experience with data reporting tools such as Qlik, JReview, and Spotfire is preferred.

• Familiarity with RBQM methodology is preferred.

• Exposure to CDISC guidelines and standards.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Remote work options.