eTMF Manager
- Employer
- KlinEra Global Services Inc
- Location
- South Bay, South San Jose, California
- Start date
- Jul 16, 2024
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- Discipline
- Clinical, 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 Minimum of 1+ year of eTMF experience
- Excellent organizational, communication, and problem-solving skills
- Ability to work independently and collaboratively in a fast-paced environment
- Proficiency in using eTMF systems (e.g., Veeva Vault, Phlexglobal, Wingspan)
Responsibilities
- Maintain and administer the electronic Trial Master File (eTMF) system
- Ensure the system is validated and compliant with regulatory guidelines (e.g., ICH GCP, FDA, EMA)
- Configure and optimize the eTMF system to meet project-specific needs.
- Oversee the uploading, indexing, and organization of essential documents into the eTMF
- Ensure completeness, accuracy, and timeliness of document filing and metadata entry
- Monitor document status and track document versions throughout the trial
- Perform regular quality checks and audits of the eTMF to ensure data integrity and compliance
- Support internal and external inspections and audits related to the eTMF
- Provide training to study teams and stakeholders on eTMF processes and best practices
- Offer technical support and troubleshooting for eTMF system users
- Collaborate with cross-functional teams (e.g., Clinical Operations, Regulatory Affairs) to ensure alignment on eTMF requirements and timelines
- Identify opportunities for process improvement and efficiency gains within eTMF management
- Stay updated on industry trends, regulatory changes, and best practices
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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