The Senior Analyst Clinical Data will act as a subject matter expert in clinical databases and data management on Clinical Project Teams. This position involves translating business needs into technical requirements, resolving complex data issues, and contributing to the development and maintenance of clinical database systems. You will work closely with various shared service functions and clinical project team members to ensure data integrity, manage regulatory submissions, and promote best practices in data management.
Key Responsibilities
1. Clinical Database Management and Data Issue Resolution
- Represent Data Management as the database and data management SME on Clinical Project Teams.
- Attend Clinical Project Team meetings to gather business requirements and translate them into technical requirements.
- Partner with other functions such as Safety, Core Lab, etc., to identify, analyze, and resolve complex data issues.
- Train end-users (internal and external) on database systems and maintain automated training systems.
- Assist in FDA and Quality audits related to Clinical Database and Data Management.
- Lead development and QC of data management documents, including data management plans and database validation protocols.
- Ensure adherence to data management standards and SOPs throughout the project lifecycle.
2. Development and Quality Control of Clinical Database Systems
- Collaborate with DM Management, Database Developers/Analysts, and Programmers to deliver database and system requirements.
- Translate business needs into technical requirements for electronic Case Report Forms (eCRFs), edit checks, study notifications, and other database customizations.
- Perform and document functional and user acceptance testing on databases and related components.
- Ensure appropriate data validation and quality control checks are in place for each study.
- Communicate effectively with the Clinical Project Team and other stakeholders regarding deliverables, timelines, and potential issues.
- Prioritize deliverables in collaboration with DM Management and other team members.
3. Data Management Expert and Standards Compliance
- Work with Biostatistics and Programmers to develop and ensure the proper use of standards in databases and systems.
- Manage and review database accounts to ensure integrity and security.
- Recommend improvements to Clinical Data Management practices, including SOPs, Work Instructions, and solutions for technology issues.
4. Data Cleaning and Database Lock
- Lead data cleaning efforts and manage data freeze/lock processes for regulatory submissions.
- Plan and monitor interim and final database locks and data reviews to ensure timelines are met.
- Coordinate all aspects of data review, including validation, queries, database QC, SAE reconciliation, medical coding, and database closure activities.
- Design tools and reports to document data reviews and assist in data cleaning activities.
- Lead data freeze activities with the Clinical Project team, Biostatistics, and SAS programming teams.
- Use tools like SQL and database UIs to identify and resolve data issues with the Clinical Project Team.
Qualifications
- Education: Bachelor’s or Master’s degree in Life Sciences, Medicine, or a related field.
- Experience: At least 5-7 years of experience in clinical data management, including experience in clinical trials, database development, and system implementation.
- Technical Skills: Proficiency in working with clinical data management systems (e.g., EDC, clinical data review, validation, and reporting tools).
- Knowledge: Strong understanding of medical terminology, data management standards, FDA regulations, and clinical trial processes.
- Project Management: Strong organizational and project management skills, with the ability to prioritize deliverables and meet deadlines.
- Communication Skills: Excellent written and verbal communication skills.
- Leadership: Ability to lead data review meetings, data freeze activities, and coordinate cross-functional efforts in a clinical trial environment.
