Clinical Data Manager
- Employer
- KlinEra Global Services Inc
- Location
- San Jose, California
- Start date
- Nov 20, 2024
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- Discipline
- Clinical, Clinical Data, Clinical Research, Clinical Trials
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
Qualifications
- Bachelor's degree in life science/related field, advanced degree preferred
- Minimum of 3+ years in clinical research industry
- Knowledge of clinical data management principles, practices, and regulatory requirements (FDA, ICH/GCP)
- Experience with Electronic Data Capture (EDC) systems and clinical trial databases
- Proficiency in data management software and tools
- Strong analytical and problem-solving abilities
Responsibilities
- Develop data management plans (DMPs) outlining data collection, validation, and cleaning processes
- Define data validation checks and edit checks to ensure data quality
- Oversee the design, development, and validation of clinical trial databases (e.g., EDC systems)
- Ensure databases are set up according to protocol specifications and regulatory requirements
- Monitor and manage data entry activities to ensure accurate and timely data collection
- Perform data cleaning activities, resolve data discrepancies, and ensure database lock readiness
- Conduct quality control checks on clinical trial data to identify and resolve data quality issues
- Collaborate with biostatisticians and programmers to support data analysis and reporting activities
- Generate data listings, summaries, and reports for clinical study teams and regulatory submissions
- Coordinate data management activities across multiple clinical trials and ensure timelines are met
- Communicate effectively with internal and external stakeholders regarding data management activities
- Maintain accurate and complete documentation related to data management activities
- Ensure adherence to Standard Operating Procedures (SOPs), ICH/GCP guidelines, and regulatory requirements
Company
Established in 2005, KlinEra provides innovative, customized clinical trial and research services to conduct ethical and efficient clinical trials that will accelerate the delivery of novel therapeutic treatments with faster patient access. As a global company, we have offices on every major continent, with our headquarters based in the heart of Silicon Valley. A significant asset is our 350 employees, reflecting our commitment to inclusivity and equity within the workplace.
KlinEra has extensive experience in a diverse number of therapeutic areas for the last two decades. A thorough understanding of specific therapeutic areas, including gastroenterology, oncology and neurology, ensures compliance and facilitates optimal delivery. Our unsurpassed network of key opinion leaders and established relationships with investigators enable expedited enrollment and quality results. To date, we've completed over 50 large-scale phase 1, 2 and 3 trials successfully by implementing complete clinical trial management, medical monitoring, data management and site management services, all utilizing high-quality protocols and Good Clinical Practices (GCP).
As a company, we strive to establish lasting values and principles, provide excellent working conditions, and give back to the community. Outside of primary business functions, KlinEra offers KlinEducate which contributes to educating the younger generation about the clinical research industry. KinEra also provides affordable medical care to over 1200 patients every month at a subsidized cost in India. KlinEra has always been committed to sustainable business practices, preserving its values, and helping the environment.
CONNECT
- Website
- https://www.klinera.com/
- Phone
- (408)791-0120
- Location
-
313 Piercy Rd
San Jose
California
95138
United States
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