Technical Clinical Data Manager Data Analyst (Remote)
Fairfield, OH - USA
Job Summary
Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates
We are partnering with a growing biotech organization seeking a Clinical Data Manager/Data Analyst to support ongoing and upcoming clinical programs across multiple therapeutic areas.
This role will sit within a highly collaborative clinical development team and is ideal for a hands-on analytical Clinical Data Manager who enjoys digging into the data identifying trends or issues proactively and developing creative solutions to improve data quality and study execution. The client is seeking someone resourceful and technically curious not just process-oriented with the ability to independently explore datasets generate meaningful reports and surface potential issues early.
The ideal candidate will bring a blend of traditional clinical data management expertise along with strong data review querying and analytical skills. Experience with R SQL SAS or other data interrogation and reporting tools is highly desirable.
Key Responsibilities
- Support clinical data management activities across studies from start-up through database lock
- Perform hands-on data review and exploratory analysis to identify data trends inconsistencies missing data patterns and potential study risks
- Develop custom reports listings and data visualizations to support proactive data cleaning and study oversight
- Utilize R SQL SAS or similar tools to query analyze and troubleshoot clinical datasets
- Partner with CROs and vendors to ensure high-quality timely data delivery
- Collaborate cross-functionally with Clinical Operations Biostatistics Statistical Programming Medical and Safety teams on data review strategies and issue resolution
- Contribute to development and review of key deliverables including:
- Data Management Plans (DMPs)
- eCRF design and completion guidelines
- Edit checks and query logic
- User Acceptance Testing (UAT)
- Data review plans and cleaning processes
- Support ongoing query management and ensure data integrity consistency and inspection readiness
- Assist with implementation of data standards reporting enhancements and process improvements
- Work independently to investigate data anomalies and recommend practical solutions in a fast-paced biotech environment
Qualifications
- BS in a scientific technical or clinical discipline
- Approximately 58 years of clinical data management experience within biotech pharma or CRO environments
- Strong hands-on experience reviewing and interrogating clinical trial data
- Experience using R SQL SAS or other querying/reporting tools to analyze clinical data and generate custom reports
- Experience with EDC systems such as Medidata Rave Oracle or Veeva
- Working knowledge of CDISC standards (SDTM/ADaM) and downstream data usage
- Experience supporting Phase II and/or III clinical trials; CNS experience is a plus
- Exposure to CRO/vendor oversight
- Understanding of clinical data structures and dictionaries including MedDRA and WHODrug
- Strong critical thinking and problem-solving skills with the ability to work independently
- Resourceful proactive detail-oriented and comfortable operating in a dynamic biotech environment
- Strong communication and cross-functional collaboration skills
Required Experience:
Manager
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