Senior Clinical Data Manager

Ocugen India Pvt Ltd; Hyderabad; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Ocugen India Pvt Ltd in Hyderabad seeks a Senior Clinical Data Manager to lead data collection and management for clinical development and marketed products. You will drive CRF development, database design, data monitoring, and validation while collaborating with the Biometrics team to meet study deliverables.

The role requires 8–12 years in clinical data management, strong regulatory knowledge (GCP/ICH/CDISC), and excellence in communication and timelines. Office-based with limited remote work.

Qualifications

• 8–12 years direct clinical data management experience in pharmaceutical development or CRO.
• Experience with clinical trials, CRFs, and EDC/IRT systems.
• Strong knowledge of GCP, ICH, FDA and CDISC requirements.

Responsibilities

• Establish data flow from collection to final analysis via a data management plan.
• Ensures the accurate collection of electronic data.
• Develops data transfer and data quality review specifications.
• Develops eCRFs and data review specifications.
• Prepare and participate in audits.
• Collaborates with cross-functional teams to ensure output for deliverables.

Skills

GCP/ICH/CDISC knowledge

Data management

Attention to detail

Communication & collaboration

Education

Bachelor's or Master's in clinical/biological/mathematical sciences

Tools

EDC databases

IRT systems

Diary applications

Job description

Job title : Senior Clinical Data Manager Reports to: VP- Operations Job purpose The Senior Clinical Data Manager is a key member of Ocugen clinical data management team. This individual will be responsible for ensuring quality data collection and management processes, CRF development, database design, data monitoring, and validation of entered data for clinical development, and/or marketed products. This individual will work closely with the Biometrics team and the rest of the team at Ocugen to execute the data collection needs of the research studies.

Duties and responsibilities

• Establishes data flow from collection to final analysis through a data management plan.
• Ensures the accurate collection of electronic data.
• Collaborates on implementation and collection of data supporting for research protocols.
• Develops data transfer specifications and data review specifications and/or data quality review plan specifications.
• Develops program standard and study-specific electronic Case Report Forms (eCRFs).
• Implement DMP and strategies.
• Develop and implement risk management strategies.
• Prepare and participate in Audits.
• Develops edit checks, validation reports to ensure quality data.
• Provides input to project timelines and ensures that project timelines for database deliverables are met.
• Ensures that project tasks are completed with acceptable quality.
• Ensure all required documentation is completed in a timely manner.
• Collaborates with other functional teams to ensure proper output of clinical data as needed for deliverables.
• Additional tasks and projects as requested.

Qualifications

• Batchelor's or master's degree in clinical, biological or mathematical sciences, or related field, or work- related equivalent.
• 8-12 years direct clinical data management experience in pharmaceutical development or CRO environment.
• Experience with clinical trials.
• Experience with CRFs, and in the development process of EDC databases, IRT systems and diary applications for data collection.
• 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.

Physical requirements : This is a largely sedentary role.

Direct reports : N/A .