Manager, Clinical Data Management

Advanced Clinical; San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k benefits

Job summary

Advanced Group is seeking an experienced Manager, Clinical Data Management to lead data management activities across clinical development programs from early-phase studies to large global late-phase trials. You will ensure the timely planning, execution, and delivery of regulatory-compliant trial data.

The ideal candidate has deep clinical data management expertise, vendor oversight experience, and a proven ability to manage complex studies while collaborating effectively with cross-functional

Qualifications

• Minimum of 8 years of clinical data management experience in supporting clinical research studies.
• Experience managing complex trials from startup through database lock.
• Proven ability to lead data management activities and vendor oversight across global programs.
• Strong knowledge of GCP, ICH guidelines, and clinical data quality standards.

Responsibilities

• Lead data management activities across the trial lifecycle, including startup, conduct, database lock, and closeout.
• Manage planning and execution of data management across multiple studies and vendors.
• Serve as the primary data management contact for internal and external stakeholders.
• Oversee EDC configuration, CRF design, and associated study documentation.
• Monitor data quality and resolve discrepancies to deliver clean databases.
• Prepare study updates and senior leadership presentations.
• Support audits and vendor assessments related to data management.

Skills

Leadership

Cross-functional collaboration

GCP knowledge

ICH Guidelines

Project management

Data management expertise

Vendor oversight

Problem solving

Education

Bachelor's degree in Life Sciences, Clinical Research, Nursing, Mathematics, Statistics, or related field

Tools

EDC platforms

eCOA familiarity

Microsoft Office Suite

Data management systems

Job description

We are seeking an experienced Manager, Clinical Data Management to lead and oversee data management activities across clinical development programs ranging from early-phase studies through large, global late-phase trials. This role is responsible for ensuring the successful planning, execution, and delivery of clinical trial data in compliance with applicable regulatory requirements, industry standards, and organizational quality expectations.

The ideal candidate will possess strong clinical data management expertise, vendor oversight experience, and a proven ability to manage complex clinical studies while collaborating effectively with cross-functional teams.

Key Responsibilities

Position Overview

We are seeking an experienced Manager, Clinical Data Management to lead and oversee data management activities across clinical development programs ranging from early-phase studies through large, global late-phase trials. This role is responsible for ensuring the successful planning, execution, and delivery of clinical trial data in compliance with applicable regulatory requirements, industry standards, and organizational quality expectations.

The ideal candidate will possess strong clinical data management expertise, vendor oversight experience, and a proven ability to manage complex clinical studies while collaborating effectively with cross-functional teams.

• Lead data management activities throughout the clinical trial lifecycle, including study startup, conduct, database lock, and closeout.
• Manage the planning, implementation, and execution of clinical data management processes across multiple clinical studies.
• Serve as the primary data management representative for internal stakeholders, external vendors, and cross-functional project teams.
• Support protocol review and provide data management input during study planning and execution.
• Oversee electronic data capture (EDC) system configuration, database development, validation activities, and discrepancy management.
• Lead the design and review of Case Report Forms (CRFs/eCRFs) and related study documentation.
• Develop, maintain, and oversee study-specific Data Management Plans (DMPs) and associated deliverables.
• Coordinate creation and maintenance of:
  • CRFs and CRF Completion Guidelines
  • Data Handling Plans
  • Data Review Plans
  • Edit Check Specifications
  • Data Transfer Specifications
  • Data Quality Plans
  • Annotated CRFs and related documentation
• Proactively monitor data quality throughout study conduct and ensure timely identification and resolution of discrepancies.
• Facilitate query management activities and work closely with study sites, vendors, and internal stakeholders to resolve data issues.
• Ensure delivery of clean, accurate, and analysis-ready clinical databases.
• Develop and maintain project timelines, status reports, resource plans, and study metrics.
• Prepare study updates and presentations for project teams and senior leadership.
• Manage relationships with contract research organizations (CROs) and data management vendors to ensure study deliverables remain on schedule and within scope.
• Contribute to study budget planning and oversee assigned vendor budgets.
• Support audits, inspections, and vendor assessments related to data management activities.
• Lead or contribute to process improvement initiatives, technology implementation projects, and departmental best practices.
• Assist in the development of data management standards, procedures, training materials, and operational processes.

Required Qualifications

• Bachelor's degree in Life Sciences, Biological Sciences, Clinical Research, Nursing, Mathematics, Statistics, or a related field.
• Minimum of 8 years of clinical data management experience supporting clinical research studies.
• Demonstrated experience managing complex clinical trials from startup through database lock.
• Strong experience collaborating with cross-functional clinical development teams.
• Comprehensive knowledge of clinical trial regulations, drug development processes, and clinical research operations.
• Experience managing external vendors and/or CRO partners.
• Strong understanding of:
  • Good Clinical Practice (GCP)
  • International Council for Harmonisation (ICH) Guidelines
  • Industry data management best practices
  • Clinical trial data quality and compliance standards
• Excellent project management and organizational skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Effective written, verbal, and presentation communication skills.
• Ability to independently manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Project, as well as other clinical systems and technologies.
• Fluent English communication skills.

Preferred Qualifications

• Master's degree in a scientific, clinical, technical, or healthcare-related discipline.
• Experience managing CROs and external service providers.
• Prior people leadership, supervisory, or mentoring experience.
• Experience supporting global clinical trials.
• Familiarity with electronic clinical outcome assessments (eCOA) and electronic data capture (EDC) platforms.
• Experience leading process improvement or technology implementation initiatives within Clinical Data Management.
• Knowledge of clinical database design, validation, and data review methodologies.
• Experience supporting regulatory inspections and audits.

Key Competencies

• Strong leadership and stakeholder management skills.
• Ability to influence and collaborate across multiple functional areas.
• Excellent attention to detail and commitment to data quality.
• Strong risk assessment and issue-resolution capabilities.
• Ability to mentor team members and contribute to a culture of continuous improvement.
• Self-motivated and capable of working independently with minimal supervision.
• Adaptability and flexibility in managing changing priorities and study demands.

#MSPTalent

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].