Clinical Data Manager/Senior Clinical Data Manager

Tubulis • Boston, MA

6d • Remote

About The Position

As our Clinical Data Manager/Senior Clinical Data Manager (CDM) you are an essential contributor to the successful execution of clinical trials, ensuring the integrity, accuracy, completeness, and quality of the clinical data from trial design through final database lock. This role partners cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Safety/ Pharmacovigilance, Regulatory Affairs, and CROs and external vendors to design, develop and implement a robust data management process that supports high-quality outcomes, timely database locks, and seamless data handoffs for reporting, analysis, and regulatory submission. The ideal candidate will be based in the Boston, MA region w ith remote opportunities available for candidates located in MA, NY, PA, RI, NJ, NC, or FL. Please only apply if you currently reside in one of these locations.

Requirements

• Bachelor’s degree in life sciences, health informatics, or related field is required; an advanced degree is preferred.
• At least 3+ years of clinical data management experience (5+ years for Senior Clinical Data Manager) in both early- and late-phase global trials in a biotech or pharmaceutical environments is required.
• Solid understanding of GCP/ICH guidelines, regulatory requirements, and industry best practices in clinical data management.
• Proficiency with EDC systems (i.e., Medidata Rave), including integration with Spotfire and familiarity with CDISC standards (SDTM), and clinical coding dictionaries (e.g., MedDRA, WHODrug).
• Excellent organizational, analytical, and communication skills, with a demonstrated ability to troubleshoot and resolve data-related issues.
• Ability to thrive both independently and collaboratively in a fast-paced, cross-functional environment.
• High attention to detail with a strong commitment to data accuracy, integrity, and quality.

Nice To Haves

• Oncology trial experience is a plus.
• Experience working in clinical operations is a plus.

Responsibilities

• Lead clinical data management activities from study initiation through database lock.
• Develop, review and maintain core data management documents, including Data Management Plans, CRFs, Edit Check Specification, Data Transfer Plans, Data Review Guidelines.
• Drill down into data irregularities and resolve issues with data miscoding, missingness, or analysis errors.
• Collaborate with internal teams and external vendors to define EDC specifications, ensure accurate CRF build, execute data cleaning activities (e.g. query resolution, SAE reconciliation, coding review), and manage the reconciliation and integration of external data sources (e.g., central labs, imaging, ePRO) into the study database.
• Facilitate cross-functional data review meetings and ensure timely resolution of data discrepancies.
• Oversee database lock planning and execution while managing CROs and external vendors to ensure all data deliverables meet project standards, timelines, and requirements for statistical analysis and regulatory submission.
• Track milestones and deliverables, and manage escalation and resolution of issues.
• Contribute to continuous improvement activities, including SOP development and implementation of best practices in clinical data management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level