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 workplace.
- Experience with clinical trials.
- Experience with CRFs, and in the development process of EDC databases, IRT systems and diary
📌 Senior Clinical Data Manager (Hyderabad)
🏢 Ocugen India
📍 Hyderabad
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