Senior Clinical Data Manager: Lead DM & UAT

Bayside Solutions; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

The Bayside Solutions, Inc. is seeking a Senior Clinical Data Manager to lead data management activities for multiple clinical studies.

You will oversee DM planning, eCRF design, database build, UAT, data review, and final database lock, coordinating with CROs and cross-functional teams to ensure inspection readiness. The role requires 5+ years in CDM within pharma/biotech, strong knowledge of ICH-GCP, CDISC standards, and excellent communication.

Qualifications

• Bachelor's degree in health sciences or related field.
• 3+ years for CDM and 5+ years for Sr. CDM in pharmaceutical/biotech; depth considered in lieu of minimum.
• Solid knowledge of clinical data management principles, trials process, and regulatory requirements.
• Strong knowledge of ICH, FDA, and GCP regulations and guidelines.
• Proficient with EDC systems, MS Word/Excel/PowerPoint.
• Experience with MedDRA and WHO Drug.
• Excellent verbal/written and interpersonal skills.
• Ability to manage multiple projects and be detail-oriented.
• Experience with CRO/vendor oversight.

Responsibilities

• Represents data management in study team meetings and provides input.
• Manages data management timelines and coordinates deliverables with study timelines.
• Generates and reviews study documents (DMPs, CRFs, build specs, data transfer specs, coding conventions).
• Oversees database setup/migrations/updates and conducts/coordinates UAT.
• Leads development of Data Review Plan and coordinates cross-functional data listings reviews.
• Coordinates internal medical coding review and data listings.
• Performs data listing reviews and resolution of queries in EDC.
• Performs SAE reconciliation per SOPs.
• Manages DM metrics, listings, and reports; oversees DM CROs/vendors.
• Reviews feedback on study documents from clinical team.

Skills

Clinical Data Management

Clinical Trials

Data Management Plans

eCRF Design

EDC Systems

Query Management

Medical Coding

Regulatory Compliance

Team Training

Cross-Functional Collaboration

Education

Bachelor's degree in Health Sciences

Tools

SAS

MedDRA

WHO Drug

CDISC

SDTM

CDASH

Job description

The Bayside Solutions, Inc. is seeking a Senior Clinical Data Manager to lead data management activities for multiple clinical studies.

You will oversee DM planning, eCRF design, database build, UAT, data review, and final database lock, coordinating with CROs and cross-functional teams to ensure inspection readiness. The role requires 5+ years in CDM within pharma/biotech, strong knowledge of ICH-GCP, CDISC standards, and excellent communication.