ETMF Manager - Oncology (Washington, DC)

We are looking for an eTMF Manager to lead the management of electronic Trial Master Files (eTMF) for clinical trials in a dynamic biopharma environment. The successful candidate will oversee the quality, completeness, and regulatory compliance of the eTMF system and play a pivotal role in ensuring the success of clinical trials. This role requires a seasoned professional with a strong background in eTMF management, regulatory compliance, and clinical trial processes. Ideal candidates will have exceptional organizational, project management, and communication skills, along with the ability to thrive in a team-oriented and fast-paced environment.
 

• Lead the implementation, maintenance, and archival of eTMF for all clinical trials.
• Ensure the quality, completeness, and regulatory compliance of the eTMF system.
• Develop and implement eTMF standard operating procedures (SOPs) and guidelines.
• Train and support study teams in the use of the eTMF system.
• Conduct regular audits of the eTMF system to ensure data integrity and compliance with regulatory standards.
• Collaborate with cross-functional teams to resolve any issues related to eTMF.
• Stay current with industry trends, regulations, and best practices for eTMF management.
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• Bachelor’s degree in a scientific or related field; Master’s degree or higher preferred.
• Minimum of 5 years of experience managing eTMF in the biopharma industry.
• Comprehensive knowledge of clinical trial processes and regulatory requirements related to eTMF.
• Proficiency in eTMF systems and other clinical trial management software.
• Strong organizational and project management skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team-oriented environment.
• Proven ability to manage multiple tasks and meet deadlines.
• Strong problem-solving skills with exceptional attention to detail.

Department: Direct Clients
This is a full time position