Monster
Find JobsSalary ToolsCareer AdviceResume HelpUpload ResumeEmployers / Post JobProfileMessage Center

Future Opportunities - eTMF Talent Pool

Initial Therapeutics, Inc.

San Jose, CA

Apply
JOB DETAILS
SKILLS
Auditing, Biology, Clinical Information Systems, Clinical Practices/Protocols, Clinical Research, Clinical Study Publications, Clinical Trial, Clinical Trial Management, Communication Skills, Cross-Functional, Customer Support/Service, Data Quality, Document Management, FDA (Food and Drug Administration), GCP (Good Clinical Practices), ICH Regulations, Industry/Trade Analysis, Maintain Compliance, Multilingual, Organizational Skills, Problem Solving Skills, Process Improvement, Quality Assurance, Regulations, Regulatory Compliance, Systems Administration/Management, Team Player, Technical Support, Time Management, Training/Teaching
LOCATION
San Jose, CA
POSTED
30+ days ago

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:

  1. eTMF System Management & Administration: Oversee the administration, validation, and compliance of eTMF systems, ensuring alignment with regulatory standards and project needs.
  2. Document Management: Ensure proper uploading, indexing, and organizing of clinical trial documents within the eTMF system. Track document versions and monitor their status throughout the trial.
  3. Compliance & Quality Assurance: Conduct regular audits and quality checks on the eTMF system to ensure data integrity and regulatory compliance.
  4. Training & Support: Provide training on eTMF processes to study teams and stakeholders, and offer ongoing technical support to users.
  5. Collaboration & Process Improvement: Work with cross-functional teams (Clinical Operations, Regulatory Affairs, etc.) to align eTMF requirements, improve processes, and identify efficiency gains.
  6. Regulatory & Industry Awareness: Stay current with industry trends, regulatory changes, and innovations related to eTMF systems and clinical research documentation.

Education:

  1. Required: Bachelor’s degree in life sciences or a related field.
  2. Preferred: Advanced degree (Master’s, PhD) in life sciences, clinical research, or a related field.

Experience:

  1. Required: Minimum of 3+ years of experience in the clinical research industry.
  2. Required: Minimum of 2+ years of hands-on experience working with eTMF systems.

Skills & Competencies:

  1. Excellent organizational, communication, and problem-solving skills.
  2. Ability to work independently and as part of a team in fast-paced environments.
  3. Experience in multilingual teams is a plus.
  4. Strong technical proficiency in eTMF systems such as Veeva Vault, Phlexglobal, and Wingspan.
  5. Solid understanding of regulatory compliance standards, including ICH GCP, FDA, and EMA.

Future Opportunity Skills & Attributes:

  1. Strong analytical and detail-oriented mindset to ensure document quality and compliance.
  2. Collaborative, adaptable, and proactive in solving challenges and meeting deadlines.
  3. Ability to work independently while keeping stakeholders informed.
#J-18808-Ljbffr

About the Company

I

Initial Therapeutics, Inc.