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Accenture · 22 hours ago

Lead Clinical Data Manager

Philadelphia, PA

Full-time

Hybrid

Senior Level, Lead/Staff

$64K/yr - $206K/yr

12+ years exp

Accenture is a global professional services company, and they are seeking a Lead Clinical Data Manager to oversee the design and maintenance of clinical data systems for trials. This role is essential for ensuring data integrity, compliance, and collaboration across various stakeholders to support successful trial execution.

Business Information SystemsConstructionConsultingInformation ServicesInformation TechnologyInfrastructureManagement ConsultingOutsourcing

No H1B

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

Qualification

Clinical Data ManagementEDC SystemsClinical PracticeCDISC CDASH/SDTMProject ManagementEnglishInterpersonal SkillsCommunication SkillsCollaborate

Required

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: pharmaceutical data management, project management and or clinical trial technology experience