clinical data manager Indiana
Job description
Job Purpose
The Clinical Data Manager is a key member of Ocugen’s Biometrics 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 Director of Biometrics, the rest of the team at Ocugen, and CROs 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.
- Provides data management consultation for research programs.
- Collaborates on development of database specifications, data management plans, 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).
- Develops edit checks, QC, validation reports to ensure quality data.
- Interface with CROs ensuring data collection systems are accurate, secure and timely.
- Provides input to project timelines and ensures that project timelines for database deliverables are met.
- Ensures that project tasks are completed with acceptable quality.
- Attends team meetings.
- Additional tasks and projects as requested.
- BS/BA degree in clinical, biological, or mathematical sciences, or related field, or nursing qualification, or work- related equivalent.
- 5+ years direct clinical data management experience in pharmaceutical development or CRO environment
- Experience with clinical trials.
- Experience with CRFs, and in development process of eDC databases (e.g. Veeva Vault), IRT systems (including randomization), and eDiary 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. The individual will be at times required to work outside of business hours depending upon the urgent deliverables/assignments.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
