Clinical Data Manager
Clinical Data Manager
Posted on :
04-07-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Act as Lead Data Manager overseeing all deliverables of activities outsourced to DM CRO for multiple studies.
- Interact and manage relationships with other functional areas to ensure high quality data management activities.
- Oversight of data collection tools (EDC DTAs EDC integrations) and essential documents (DMP UAT Documents data edit specifications annotated case books and data entry guidelines).
- Participate in User Acceptance Testing Activities for the applicable Data Collection Tools.
- Perform Quality Control for the data completeness and accuracy.
- Participate in and support data cleaning query generation and resolution and review of medical coding as needed.
- Responsible for adhering to the Data Management timelines and budget.
- Provide technical expertise to help in the use of technologies for Data Management and the clinical study team.
- Contribute to the development of lessons learned and best practices as well as help develop SOPs and internal working procedures and process improvement initiatives.
- Contribute to the establishment of systems and tools to help ensure clinical data security and integrity.
- Contribute to the process to identify evaluate and select external business partners and technology vendors.
Requirements:
- 8 years experience in clinical data management in biotechnology or pharmaceutical industry with outsourced CRO oversight experience.
- Must have advanced knowledge of Data Management processes and systems
- Oncology experience required.
- Solid understanding of CDISC standards required.
- Data Visualization Tool experience preferred.
- Experience using standardized medical terminology including but limited too MedDRA and WHO Drug.
- Excellent interpersonal communication and organizational skills with the ability to work independently and in a study team environment.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
Key Skills
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