Director, Clinical Data Management Job at The Lotus Group LLC, San Mateo, CA

eWpGUXVHZGdJRlh6ZFlmUDJuM3ZmKzMzRGc9PQ==
  • The Lotus Group LLC
  • San Mateo, CA

Job Description

Global Pharmaceutical Company | Hybrid — Weekly On-Site Required

The Opportunity

A global pharmaceutical company is looking for a Director of Clinical Data Management to lead data operations across a growing clinical portfolio. This is a hands-on leadership role with a hybrid schedule that includes required weekly on-site presence. Candidates must be able to commute to site on a weekly basis — remote-only arrangements will not be considered.

What You'll Own

  • End-to-end CDM accountability across Phase I–III studies, from database design through database lock
  • Build, manage, and develop a high-performing CDM team
  • Drive CRF design, data validation specifications, edit check development, and data management planning
  • Oversee CRO and CDM vendor performance — scope, timelines, quality, and escalation
  • Lead CDISC/CDASH standards implementation and ensure consistency across the portfolio
  • Serve as the CDM functional lead on cross-functional study teams alongside Biostatistics, Clinical Operations, and Regulatory
  • Ensure inspection readiness across all active studies; represent CDM in regulatory audits as needed
  • Partner with IT and systems teams on EDC platform management and optimization

What We're Looking For

  • 10+ years of clinical data management experience in pharma, biotech, or CRO settings
  • 4+ years leading or managing CDM teams
  • Proven track record across multiple concurrent global trials, Phase I through III
  • Strong EDC platform experience (Medidata Rave or equivalent)
  • CDISC standards expertise — CDASH required, SDTM familiarity expected
  • Experience with multi-CRO oversight and risk-based monitoring models
  • Regulatory inspection experience (FDA, EMA, or equivalent) preferred
  • Direct communicator with the credibility to engage senior cross-functional stakeholders

Education

Bachelor's degree in a life sciences or related field required. Advanced degree a plus. CCDM certification viewed favorably.

Location & Schedule

Hybrid schedule with weekly on-site presence required. Candidates must reside within commuting distance or be open to relocation.

Job Tags

Remote work, Relocation

Similar Jobs

The University of Texas Elementary School

Part-Time Psychology Research Associate Job at The University of Texas Elementary School

 ...Job Posting Title: Part-Time Psychology Research Associate ---- Hiring Department: Department of Psychology ---- Position Open To: All Applicants ---- Weekly Scheduled Hours: 19---- FLSA Status: Non-Exempt ---- Earliest Start Date:... 

Softcom Systems Inc

CRM Coordinator Job at Softcom Systems Inc

 ...execution and reporting, in partnership with the vendor Braze. Log, track, and help resolve issues across CRM platforms, including Salesforce, Braze, SDKs, Redfast, and related tools. Organize and maintain team assets, including naming conventions, calendars, and... 

Confidential

Public MiddleSchool ESL Teacher-Hangzhou Job at Confidential

We are urgently looking for teachers to fill the following position: Middle School Teacher : A middle school urgently requires English teachers. Salary and Apartment: Up to 25k RMB per month, depending on experience and qualifications. Modern and clean apartment...

EVERSANA

Oncology Sales Representative - Detroit/Grand Rapids Job at EVERSANA

 ...grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to the market and support the patients who depend on... 

Trinity Solar

Information Technology Trainee Job at Trinity Solar

 ...analytical thinking, problem-solving, and the ability to exercise developing independent judgment in evaluating information, supporting...  ...Statistics, or a related field, or equivalent practical experience Internship or academic project experience in technology-related fields...