Ocugen · 22 hours ago
Principal Clinical Data Manager
Malvern, PA
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expOcugen is a company focused on clinical development, and they are seeking a Principal Clinical Data Manager to provide strategic leadership and oversight of clinical data management activities. This role involves managing a team, ensuring high-quality data collection and compliance with regulatory standards, and collaborating with stakeholders to maintain data integrity and implement best practices.
BiopharmaBiotechnologyHealth Care
Responsibilities
Lead data management activities, ensuring accuracy, consistency, and compliance with regulatory standards
Will be single point of contact for delivery of all data management activities for studies with offshore data managers
Evaluates and provides recommendations for acquiring and implementation of new tools and implements them with minimum disruption to business
Represents Director of data management at cross functional meetings, negotiates data management requirements in line with departmental objectives, Plans, communicates to relevant stakeholders and implements solutions with approval from the Director of data management
Communicates effectively with all levels of the organization and achieves alignment for all stakeholders while delivering data management activities
Advises the Director of data management on all data management challenges, questions with effective solutions
Oversee database build activities, data collection, coding, cleaning, and database lock
Develop and execute data management plans, including risk management strategies
Work closely with internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs, to facilitate seamless data flow and compliance
Serve as the primary data management contact for assigned therapeutic areas, ensuring proper planning and issue resolution
Ensure timely and quality deliverables within project timelines and budget constraints
Develop and implement validation checks, conduct data reviews, and resolve data discrepancies to maintain high data standards
Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and CDISC standards
Supervise database development, validation, and transfer processes in accordance with SOPs and regulatory requirements
Provide subject matter expertise in clinical data management systems, electronic data capture (EDC) platforms, and data standards such as CDISC
Develop and manage electronic Case Report Forms (eCRFs), data transfer specifications, and validation reports
Establish and refine data management standard operating procedures (SOPs) and best practices
Mentor and train junior data managers, fostering a collaborative environment and continuous learning culture
Ensure direct reports have adequate training and skills to meet regulatory and company standards
Guide teams on clinical data management best practices and evolving industry requirements
Maintain GCP inspection readiness by ensuring proper documentation and compliance with regulatory requirements
Serve as the primary point of contact for data management activities during audits and inspections
Review and approve key project documents, including Data Management Manuals, CRF Completion Guidelines, and validation specifications
Qualification
Required
Bachelor's degree in clinical, biological, or mathematical sciences, nursing, or a related field
Minimum of 6+ years of clinical data management experience in pharmaceutical development or CRO environment
Extensive experience with clinical trials, EDC databases, IRT systems, and diary applications for data collection
Strong knowledge of GCP, ICH, FDA, and CDISC regulatory requirements governing clinical studies
Proven ability to develop SOPs, risk management strategies, and data management plans
Demonstrated leadership, problem-solving, and project management skills
Excellent organizational, communication, and collaboration skills with a team-oriented approach
Self-motivated with a commitment to high-quality, on-time deliverables
Company
Ocugen
Ocugen is a biotechnology company that develops novel gene and cell therapies to improve health and patient outcomes.
51-200 employees
H1B Sponsorship
Ocugen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$314MKey Investors
RTW InvestmentsJanus Henderson InvestorsAvenue Capital Group
2026-01-21Post Ipo Equity· $22.5M
2025-08-08Post Ipo Equity· $20M
2024-11-07Post Ipo Debt· $30M
Leadership Team
Shankar Musunuri
Chairman, CEO & Co-Founder
Arun Upadhyay
Chief Scientific Officer
Recent News
BioWorld Financial Watch
2026-01-23
2026-01-22
Company data provided by crunchbase