Thank you for considering a future opportunity with our company. We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in future positions. By joining our talent pool, you will be the first to know when suitable opportunities arise.
Job Description: We are seeking qualified candidates to join our talent pool for future opportunities within the eTMF Services Department. Ideal candidates will have expertise in managing clinical trial documentation systems and ensuring compliance with regulatory standards. This position requires a strong background in clinical research and eTMF systems, with an emphasis on organization, compliance, and process improvement.
Responsibilities:
- Oversee the administration, validation, and compliance of eTMF systems, ensuring alignment with regulatory standards and project needs.
- Ensure proper uploading, indexing, and organizing of clinical trial documents within the eTMF system. Track document versions and monitor their status throughout the trial.
- Conduct regular audits and quality checks on the eTMF system to ensure data integrity and regulatory compliance.
- Provide training on eTMF processes to study teams and stakeholders, and offer ongoing technical support to users.
- Work with cross-functional teams (Clinical Operations, Regulatory Affairs, etc.) to align eTMF requirements, improve processes, and identify efficiency gains.
- Stay current with industry trends, regulatory changes, and innovations related to eTMF systems and clinical research documentation.
Education:
- Required: Bachelor's degree in life sciences or a related field.
- Preferred: Advanced degree (Master's, PhD) in life sciences, clinical research, or a related field.
Experience:
- Required: Minimum of 3+ years of experience in the clinical research industry.
- Required: Minimum of 2+ years of hands-on experience working with eTMF systems.
Skills & Competencies:
- Excellent organizational, communication, and problem-solving skills.
- Ability to work independently and as part of a team in fast-paced environments.
- Experience in multilingual teams is a plus.
- Strong technical proficiency in eTMF systems such as Veeva Vault, Phlexglobal, and Wingspan.
- Solid understanding of regulatory compliance standards, including ICH GCP, FDA, and EMA.
What We Offer:
- Competitive salary
- Opportunity to work on cutting-edge projects and make a significant impact
- Supportive and dynamic work environment
- Professional development and growth opportunities
Additional Information:
Founded in 2005, KlinEra is a global leader in providing innovative and customized clinical trial services designed to accelerate the delivery of novel therapeutic treatments. With a presence on every major continent and headquarters in Silicon Valley, KlinEra is committed to conducting ethical and efficient clinical trials, enabling faster patient access to groundbreaking therapies. With over 20 years of experience, KlinEra excels in various therapeutic areas, including gastroenterology, oncology, and neurology. Our deep understanding of these fields ensures compliance and supports the successful delivery of clinical trials. In addition to our core business functions, KlinEra is dedicated to giving back to the community through initiatives like KlinEducate, which educates the younger generation about the clinical research industry, and by providing affordable medical care to over 1,200 patients monthly in India. If you can resonate with what KlinEra provides as a company, please join our pipeline.