Sr Clinical Data Manager
Job Description
Genesis10 is seeking a Sr Clinical Data Manager for a leading company in San Diego, CA. This remote 6-month contract with high potential of hire role pays $60-70/HR W2 based on experience.
Summary:
Responsible for data management activities including, but not limited to, developing data management plans, department SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trials databases.
Essential Duties AND Responsibilities
Summary:
Responsible for data management activities including, but not limited to, developing data management plans, department SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and consistency of clinical trials databases.
Essential Duties AND Responsibilities
- Designs clinical trial specific subject Case Report Forms for use in e-clinical EDC systems.
- Develops study specific annotated CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.
- Designs and validates clinical databases including designing logic checks, UAT etc.
- Programs SAS edit checks and SAS macros for clinical trials, encompassing ETL processes, data validations, statistical analysis, and report generation.
- Responsible for filing and maintaining CRFs, subject diaries, and other subject-specific documentation (e.g., Marketing questionnaires) collected during clinical studies.
- Responsible for filing and maintaining digital data collected during clinical studies.
- Conduct data automation tasks, including software development, testing, and validation. Familiarity with Power BI, R, Python, HTML, JavaScript, and REST APIs for data downloading is a plus.
- Knowledge of the software development life cycle (SDLC) and experience in coding and design.
- Summarizes basic elements for clinical databases periodically.
- Communicates with end users to define or implement clinical data management requirement for the clinical study such as data release, delivery schedules, and testing protocols.
- Provides training and technical support to clinical site personnel on EDC for specific studies.
- Maintains more than 3 study databases and data management activities concurrently. * Ability to multi-task while still being detail oriented.
- Develops project-specific data management plans that address areas such as data reporting, transfer, database lock and work flow.
- Monitors work quality to ensure compliance with standard operating procedures.
Required Skills (top 3 non-negotiables):
- Strong expertise in SAS program and SAS macros
- Data Automation system
- Design and maintain clinical databases in EDC
Preferred Skills (nice to have)
- Create CRF and Data management documentation
- Data visualization tools (Power BI)
- R or Python
Education Requirements: Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience
Software Skills Required: SAS, SQL, R, Python
Required Certifications**: SAS base certification
Potential to Extend? YES
Potential to Convert to FTE? YES
If you have the described qualifications and are interested in this exciting opportunity, please apply!
About Genesis10: Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.
For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:
Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
Behavioral Health Platform
Medical, Dental, Vision
Health Savings Account
Voluntary Hospital Indemnity (Critical Illness & Accident)
Voluntary Term Life Insurance
401K
Sick Pay (for applicable states/municipalities)
Commuter Benefits (Dallas, NYC, SF)
Remote opportunities available
For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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Genesis10 is an Equal Opportunity Employer/Minorities/Female/Disabled/Veteran
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