Lead Clinical Data Manager

CooperCompanies • $164K — $219K *
San Ramon, CA 94582In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life science, computer science, or related field and 8 years of Clinical Data Management experience; or a Master's degree with 5 years of experience.
  • Proficient in electronic data capture (EDC) and clinical data management systems (e.g., REDCap, Medidata).
  • Expertise in database design, validation, and integration of external data.
  • Strong SQL skills to query datasets effectively.
  • Demonstrated leadership skills for cross-functional team guidance and mentoring.
  • Experience with vendor data integration and familiarity with statistical tools like SAS or R is preferred.
  • Ability to adapt and leverage emerging technologies, particularly AI tools, for operational excellence.

Responsibilities

  • Generate and review key documentation like data management plans and case report forms (CRFs).
  • Lead the development of electronic case report forms (eCRFs) and facilitate reviews of content.
  • Design, develop, and validate clinical trial databases and eCRFs, implementing quality checks.
  • Train personnel on the EDC system and data management processes.
  • Ensure high-quality datasets are delivered by overseeing data cleaning and resolving queries.
  • Serve as the liaison for vendors, maintaining communication about data deliverables.
  • Develop and update standard operating procedures (SOPs) to meet regulatory standards.

Benefits

  • Minimal travel requirements (5%) to research centers for data management improvement.
  • On-site work environment for team collaboration.
  • Opportunities to adopt emerging technologies and contribute to innovation initiatives.
  • Engagement with various functional teams within the company.
  • Exposure to compliance with strict regulatory standards in clinical trials.
Full Job Description
Job Description

Job Summary:

Leads all aspects of clinical data management activities from study initiation through database lock and study closeout. Develops, optimizes and controls data management system, including external clinical research centers in compliance with medical device regulations. Oversees and ensure that all CooperVision sponsored clinical trial data are accurate, complete, and compliant.

Responsibilities

  • Generate, contribute, and/or review key study documentation such as data management plans, case report forms (CRFs), database specifications, test plans for user acceptance testing (UAT), and data transfer specification and agreements
  • Lead electronic case report form (eCRF) developments and facilitate cross-functional reviews of eCRF content
  • Support the design, development, and validation of clinical trial databases and eCRFs, including edit checks within the Electronic Data Capture (EDC) system
  • Perform training on the EDC system, dataflow, and quality control (QC) processes to personnel as appropriate
  • Perform and/or oversee data cleaning, issue queries, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions; assist Clinical Operations, Biostatistics, Statistical Programming, Investigational sites, and/or Clinical Research Organization with resolving queries
  • Perform third party non-Case Report Form data management activities
  • Ensure delivery of datasets, annotated CRFs, and related materials in the appropriate formats
  • Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., FDA, EU MDR, PMDA, NMPA).
  • Lead efforts in developing and maintaining standard database validation checks for common modules as well as for indication or research objective specific modules
  • Ensure that documentation and data records, including archiving, meet regulatory and inspection standards
  • Ensure compliance with industry standards and regulations (ISO, FDA, EU MDR) and assist in audit and inspection readiness
  • Champion and assist the effective utilization of AI tools to enable automation, continuous process improvements, technology modernization, and efficiency initiatives.
  • Serve as the main liaison for vendors or partners handling data deliverables, clarifying expectations and maintaining streamlined communication between internal and external teams
  • Develop and/or modify standard operating procedures (SOPs) for clinical data management to comply with industry standards and regulations
  • Establish and manage data quality standards, ensuring adherence to internal procedures and external guidelines
  • Perform importing and reconciling external datasets, maintaining consistency across all study databases
  • Track and communicate progress metrics, risks, and outcomes to senior management
  • Coordinate closely with functional leads in Clinical Research, Clinical Operations, Biostatistics, Safety, and/or Regulatory Affairs to ensure seamless data flow and reporting


Travel Requirements:
Minimal travel (5%) required, occasionally to research centers to establish or improve data management procedures.

Qualifications

Knowledge, Skills and Abilities:
  • Bachelor's degree in life science, computer science or closely related discipline plus minimum of 8 years of experience in Clinical Data Management, or
  • Master of Science in life science, computer science or closely related discipline plus minimum of 5 years of experience in Clinical Data Management
  • Highly dependable, good time management and multitasking skillsets
  • Proficiency with common electronic data capture (EDC) and clinical data management platforms, and clinical data systems (e.g., REDCap, Medrio, Medidata RAVE, Veeva).
  • Expertise in database design, validation, and oversight of external data integration.
  • Expert in the use of SQL to query datasets.
  • Passion for exploring and adopting emerging technologies, including AI-enabled tools, to support innovation, operational excellence, and business transformation
  • Strong problem-solving ability to navigate complex unforeseen situations
  • Strong leadership skillsets to guide and mentor within and cross-functional team members
  • Strong on written and verbal communications
  • Experience with integrating data from external vendors or systems.
  • Familiarity with statistical or visualization tools such as SAS or R is preferred.
  • Ability to read and understand highly technical material.


Work Environment:
  • On-site 5 days a week in-office required
  • Normal office environment and ophthalmic clinical exam room
  • Sedentary to light physical effort necessary to perform the job.
  • Extensive contact with employees and external researchers
  • Extensive computer and keyboarding


For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $164,819.00 and $219,758.00. per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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About CooperCompanies

CooperCompanies Careers

Joining CooperCompanies presents an unparalleled opportunity to become part of a global team dedicated to fostering innovation, leadership, and professional growth. As a leading entity in the medical sector, CooperCompanies offers a range of job opportunities that cater to a diverse set of skills and experiences.

Explore Career Opportunities

CooperCompanies is actively hiring and continuously seeks passionate, creative, and solution-driven team players. Explore open positions that align with your professional interests and expertise. Each position at CooperCompanies is a chance to thrive in a culture that values diversity and leadership.

Professional Growth and Development

At CooperCompanies, career growth is a priority. The company supports professional development through comprehensive training programs, including leadership development and diversity training. These initiatives ensure that every team member has the tools and knowledge to advance their career.

Innovation and Team Collaboration

Innovation is at the heart of CooperCompanies. The team collaborates on projects that push the boundaries of technology and service in the medical field. Working at CooperCompanies means joining forces with some of the brightest minds in the industry to deliver solutions that truly make a difference.

Internship Programs

For those starting their career journey, CooperCompanies offers internship programs that provide a robust introduction to the medical industry. Internships are a pivotal step for gaining real-world experience, enhancing your resume, and building a professional network.

Benefits and Company Culture

CooperCompanies is committed to supporting its employees with exceptional benefits and a nurturing work environment that promotes a balance of professional and personal growth. The company culture is built on a foundation of respect, inclusion, and collaboration, making it a prime workplace for individuals from all walks of life.

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Employees at CooperCompanies are encouraged to engage in networking opportunities within and beyond the company. This connectivity is vital for fostering relationships that can lead to innovative collaborations and career advancement.

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Industry
Healthcare
* Ladders Estimates

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