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Clinical Data Analyst
3 weeks ago
Clinical Data Management Specialist
Job Description:- The clinical data management specialist plays a pivotal role in the success of clinical trials by ensuring the accuracy, quality, and integrity of trial data.
- This includes defining project specifications for data management services, including protocol conversion, database build, CRF design, and data review and reconciliation tools.
- They must have a deep understanding of external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance.
- In addition, they will execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables.
- Performing holistic data review and trending analysis via reporting and analytics is also a key responsibility, as is the proactive identification of issues, risks, and development of mitigation strategies.
- The use of artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection is essential to enhance the efficiency and quality of trial data.
- Monitoring and interpreting key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports is crucial in providing actionable recommendations to study leads/project managers.
- Query management is also an essential function.
- Defining specifications and collaborating with technical teams on configuring centralized data management platforms, such as elluminate Data Central, for data cleaning strategy and oversight activities is critical.
- Preparing and maintaining data management documentation, including DMPs, CCGs, help text, and DVSs, and updating throughout the trial lifecycle is also a key responsibility.
- Strong understanding of clinical trial data management principles and practices.
- Excellent analytical and problem-solving skills.
- Ability to work independently and collaboratively as part of a team.
- Strong communication and interpersonal skills.
- Proficiency in data management software and systems, including elluminate Data Central.
- Opportunity to work on high-profile clinical trials.
- Collaborative and dynamic work environment.
- Professional growth and development opportunities.
- Compliance with industry quality standards, regulations, guidelines, and procedures is essential.
- Other duties may be assigned as needed.