Senior Clinical Data Manager - Strategy & Analytics

eClinical Solutions, LLC; Mansfield (MA); On-site; USD 125,000 - 145,000; Full time

Job summary

eClinical Solutions, LLC is seeking a highly skilled Principal Clinical Data Manager to lead data management across the full lifecycle of complex clinical trials. You will guide cross-functional teams including operations, biostatistics, and programming to ensure data integrity and timely delivery of study deliverables.

The role requires a strong background in Clinical Data Management, CCDM certification preferred, and extensive experience with CDISC and regulatory guidelines.

Qualifications

• Bachelor’s degree or higher in a health science or related field; 10+ years in Pharmaceutical/Biotechnology with Clinical Data Management or equivalent.
• CCDM certification preferred.
• Strong project management and leadership skills, with experience in agile and Six Sigma methodologies.
• Excellent consulting and client relationship management abilities.
• Proficiency in ICH/GCP guidelines, 21 CFR Part 11 and data management systems.

Responsibilities

• Serve as the primary DM representative for the sponsor interaction and ensure data management processes meet quality and timelines.
• Act as DM subject matter expert on best practices, technology, and solutions.
• Define study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management.
• Collaborate with technical teams to configure elluminate for data cleaning and oversight.
• Perform QC on deliverables and monitor data trends to identify risks and mitigation strategies.
• Partner with cross-functional teams to drive process improvements and training.

Skills

Project management

Client relations

Analytical thinking

English proficiency

MS Project

MS Excel

Qlik

JReview

Spotfire

GxP/ICH Guidelines

Education

Bachelor's degree or higher

Master's degree preferred

Tools

MS Project

MS Excel

Qlik

JReview

Spotfire

Job description

eClinical Solutions, LLC is seeking a highly skilled Principal Clinical Data Manager to lead data management across the full lifecycle of complex clinical trials. You will guide cross-functional teams including operations, biostatistics, and programming to ensure data integrity and timely delivery of study deliverables.

The role requires a strong background in Clinical Data Management, CCDM certification preferred, and extensive experience with CDISC and regulatory guidelines.