Lead Clinical Data Manager

AccenturePhiladelphia, PA
9dHybrid

About The Position

The Lead Clinical Data Manager (LCDM) is a Career Level 9 (CL9) responsible for overseeing the design, implementation, and maintenance of clinical data systems and processes (including change management) to ensure high-quality data collection and integrity across clinical trials. This role plays a critical part in driving innovation, ensuring compliance, and collaborating cross-functionally to support successful trial execution.

Requirements

  • Bachelor’s degree or equivalent experience (Minimum 12 years of experience or 6 years with an Associate’s Degree).
  • Minimum 4 years of experience in one of a combination of the following areas: clinical data management, project management and or clinical trial technology experience.
  • This role requires hybrid onsite work at the client site in Southeastern PA or Northern NJ
  • Proficiency in English (written and verbal).

Nice To Haves

  • Degree in in Data Management, MIS, Biological/Clinical Sciences, or related field.
  • Proven leadership in clinical data management.
  • Expertise in EDC systems and clinical trial technologies.
  • Familiarity with CDISC CDASH/SDTM standards.
  • Strong knowledge of Good Clinical Practice (GCP).
  • Excellent interpersonal, communication, and project management skills.
  • Ability to work independently and collaboratively.

Responsibilities

  • Direct the development and maintenance of clinical trial databases for pharmaceutical and biologic compounds.
  • Design and execute comprehensive edit checks to ensure data accuracy, consistency, and compliance with regulatory standards.
  • Collaborate to resolve complex data discrepancies and ensure clean datasets.
  • Develop Data Validation Plan; partner with study teams to analyze data, troubleshoot issues, and communicate findings with investigator sites.
  • Lead the implementation of paperless studies using Electronic Data Capture (EDC) systems and contribute to process optimization while reinforcing change management principles.
  • Work closely with clinical researchers, project managers, statisticians, and other stakeholders to meet project goals.
  • Implement Quality by Design (QbD) frameworks.
  • Support enhanced Ways of Working (WoW) initiatives to promote first-time-right (FTR) execution.
  • Define and track metrics to measure process improvements and outcomes.
  • Align training strategies with the Zero Gravity program and develop Just-in-Time (JIT) training content.
  • Execute study build and related process tasks in alignment with timelines and deliverables.
  • Maintain documentation in accordance with Client SOPs and regulatory guidance.
  • Respond to User Acceptance Testing (UAT) findings and implement corrective/preventive actions.
  • Serve as the primary CDM point of contact for assigned studies and collaborate with Client Leads on strategy and process improvements.

Benefits

  • Accenture offers a market competitive suite of benefits including medical, dental, vision, life, and long-term disability coverage, a 401(k) plan, bonus opportunities, paid holidays, and paid time off.
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