Lead Clinical Data Manager: Drive Trial Data Excellence

Comunidade Metodista; Redwood City (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Planet Group in Redwood City, CA is seeking a Clinical Data Manager to lead data management activities across the CDM lifecycle, including study documentation, system setup, UAT, and database lock for clinical trials.

The role requires 3+ years in CDM with solid knowledge of ICH, FDA, and GCP regulations, and proficiency with EDC systems and MS Office. Strong communication and cross‑functional collaboration skills are essential.

Qualifications

• Bachelor's degree required.
• 3+ years of CDM/Data Management experience in pharma/CRO.
• Solid knowledge of clinical data management principles.
• Strong knowledge of ICH, FDA, and GCP regulations.
• Proficient with EDC systems and MS Office.
• Experience with MedDRA/WHO Drug thesauri.
• Excellent verbal and written communication; cross-functional teamwork.
• Ability to manage multiple tasks and meet deadlines.

Responsibilities

• Manage data management duties to meet study timelines.
• Review data listings, metrics, listings, and reports.
• Perform data listing review and resolve queries in EDC.
• Coordinate external data reconciliation and SAE reconciliation.
• Provide DM support to Statisticians and Programmers in trial reports.
• Generate/ review study documents (DM Plans, CRFs, DB build specs).
• Maintain inspection-ready study DM documentation.
• Oversee CRO/service providers and manage DM progress on studies.
• Assist in training new employees/contractors.
• Contribute to development and implementation of SOPs and templates.

Skills

CDM experience

ICH/FDA/GCP knowledge

Cross-functional teamwork

Independent working

Detail oriented

Multi-tasking

Communication skills

Education

Bachelor’s degree

Tools

EDC systems

MS Word

MS Excel

MS PowerPoint

MedDRA/WHO Drug

Job description

Planet Group in Redwood City, CA is seeking a Clinical Data Manager to lead data management activities across the CDM lifecycle, including study documentation, system setup, UAT, and database lock for clinical trials.

The role requires 3+ years in CDM with solid knowledge of ICH, FDA, and GCP regulations, and proficiency with EDC systems and MS Office. Strong communication and cross‑functional collaboration skills are essential.