eTMF Specialist-Contract

Company Description

Sia Partners is a next-generation consulting firm focused on delivering superior value and tangible results to its clients as they navigate the digital revolution. Our global footprint and expertise in more than 40 sectors and services allow us to enhance our clients’ businesses worldwide. We guide their projects and initiatives in strategy, business transformation, IT & digital strategy, and Data Science.

Job Description

Latham BioPharm Group, a part of Sia Partners, provides the insight, knowledge, and network to unite teams and technologies in the Life Sciences. We provide the depth of expertise necessary to advance programs, by providing a range of life science services including business development, program management, CMC, non-clinical, quality, regulatory, and strategic consulting with proven experience in biodefense/pandemic response and strategic product development.

We are currently in need of an eTMF Specialist contractor. Reporting to the Clinical Operations Leader, this contractor will be responsible for the day-to-day management of eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF. This role has a strong focus on ensuring that document management operations are performed with adherence to ICH-GCP guidelines, other regulatory requirements, and standard operating procedures (SOPs). The role will also ensure the eTMFs for clinical studies are always inspection ready. 

Project Length: 3 years

Location:  Remote

Responsibilities

• Lead the development of the study specific eTMF plans for assigned clinical studies.
• Perform quality control of documents submitted to the eTMF using the established acceptable criteria.
• Generate Study Metrics on a regular basis and collaborate with study teams where improvements can be made.
• Ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
• Address eTMF questions pertaining to how documents are filed, and user questions related to the eTMF system.
• Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
• Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
• Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed.
• Assist with inspection/audit related activities (e.g., preparation, correction action plans)
• Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements.

Qualifications

• Minimum B.A./B.S. degree in science/healthcare field required.
• 2+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO required.
• Previous experience working in eTMF system software; experience in Veeva Vault eTMF system software preferred.
• Solid understanding of the clinical trial process.
• Experience in handling clinical trial related documents required and knowledge of Trial Master File Reference Model Structure standard.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management.
• Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) guidelines. 
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment.
• Strong organizational skills with outstanding attention to detail and follow through.
• Demonstrated effective communication skills to internal and external team members.
• Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities while exhibiting the highest level of customer service.
• Demonstrated proactive approaches to problem-solving with strong decision-making capabilities.
• Must be fully proficient in MS Office Suite, and conversant with Smartsheets and SharePoint.

Additional Information

Our Commitment to Diversity

Diversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an environment in which everyone can reach their full potential.

Our global network, DEIB@Sia Partners, brings together our people worldwide to facilitate local and global progress, focused on the f