Clinical Data Manager

Job purpose:

The Clinical Data Manager is a key member of Ocugens 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).
• Develop and revise SOPs, 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.
• Lead junior Data management staff.
• Collaborates with other functional teams to ensure proper output of clinical data as needed for deliverables.
• Additional tasks and projects as requested.

Qualifications :

• BS degree in clinical, biological or mathematical sciences, or related field or nursing qualification, or work- related equivalent.
• 6+ 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.
• Experience in working with USA biopharmaceuticals/pharmaceuticals companies or client.

• Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA.

Working

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

This is a largely sedentary role.