Senior Clinical Data Manager

BioSpace; Malvern (Chester County); On-site; USD 110,000 - 145,000; Full time

Job summary

Ocugen seeks a Senior Clinical Data Manager to lead data management across programs and oversee quality data collection and processes for clinical trials and marketed products.

You will design CRFs, oversee database design, monitoring, validation, and ensure compliance with GCP, ICH, FDA, and CDISC standards while mentoring junior staff and coordinating with Biometrics, Clinical, and Regulatory teams.

Qualifications

• BS degree in clinical, biological or mathematical sciences, or nursing qualification, or work- related equivalent.
• 5-7 years of clinical data management experience in biopharma or CRO environment.
• Experience with CRFs, development of EDC databases, IRT systems and diary applications for data collection. Veeva experience is preferred.
• Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies.
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality, on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.

Responsibilities

• Oversee studies or a program, ensuring cross-study consistency and mentoring team members.
• Make higher level decisions on data standards, risk-based data management strategies, and protocol-driven design choices.
• Lead inspection readiness and ensure documentation completeness across studies.
• Serve as SME during audits and guide SOP alignment with GCP, ICH, CDISC requirements.
• Provide strategic input to Clinical Operations, Biostatistics, Programming, and Quality on data flow and database improvements.
• Lead the development and execution of data management plans (DMPs) and eCRF designs.
• Develop and validate edit checks and validation reports to maintain high-quality data.
• Prepare for and participate in audits and ensure compliance with data management processes.

Skills

Attention to detail

Communication

Team collaboration

Time management

Education

Bachelor's degree in clinical/biological/scientific field or nursing qualification

Tools

Veeva

Job description

Position Summary

The Senior Clinical Data Manager plays a pivotal role within Ocugen's clinical data management team. This individual will lead data management efforts, oversee quality data collection and management processes, and contribute to critical aspects of clinical trial data handling, including database design, CRF development, data monitoring, and validation for clinical development programs and marketed products. In addition to technical responsibilities, the Senior Clinical Data Manager will provide leadership to junior data management staff and work collaboratively across functional teams, ensuring high-quality and timely deliverables.

Responsibilities

• Oversee studies or a program, ensures cross study consistency, mentors team members, and manage vendors as needed.
• Makes higher level decisions on data standards, risk based data management strategies, and protocol driven design choices.
• Leads inspection readiness, ensures documentation completeness across studies,
• Serves as a subject matter expert during audits, helps standardize SOP alignment, guides the team in applying GCP, ICH, CDISC, and internal compliance expectations.
• Provides strategic input to Clinical Operations, Biostatistics, Programming, and Quality on data flow, database design improvements, standards adoption, and process optimizations.
• Represents DM in program level meetings and drives improvements across studies (aligned with broader responsibilities seen in senior and principal level descriptions).
• Provide mentorship and technical guidance to junior data management staff.
• Ensure accurate and efficient collection of electronic clinical trial data.
• Develop and validate edit checks and validation reports to maintain the highest quality data.
• Ensure all required documentation is completed accurately and promptly across studies.
• Develop and implement innovative data strategies to streamline data management workflows.
• Identify and mitigate risks in data management processes proactively.
• Take the lead on special projects and additional tasks as required by management.
• Lead the development and execution of data management plans (DMPs), ensuring seamless data flow from collection to final analysis.
• Design and oversee program standards and study-specific electronic Case Report Forms (eCRFs).
• Partner with Biometrics, Clinical, and Regulatory teams to implement research protocols and ensure proper clinical data outputs for deliverables.
• Develop and manage data transfer specifications, data review plans, and risk management strategies.
• Collaborate on cross-functional project timelines and ensure database deliverables are achieved within schedule and quality standards.
• Author and revise standard operating procedures (SOPs) and study-specific DMPs.
• Prepare for and participate in audits, ensuring data management processes meet compliance standards.

Qualifications

• BS degree in clinical, biological or mathematical sciences, or related field, or nursing qualification, or work- related equivalent.
• 5-7 years of clinical data management experience in biopharma or CRO environment.
• Strong attention to detail and motivation to provide quality deliverables.
• Able to work in a fast-paced environment.
• Experience with clinical trials.
• Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection. Veeva experience is preferred.
• Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies.
• Demonstrated attention to detail and outstanding organization skills.
• Self-motivated with a commitment to high quality, on-time deliverables.
• Excellent communication and collaboration skills with a team-oriented approach.
• Demonstrated ability to identify and resolve issues and effectively manage timelines.

Working Conditions

This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.