Archive Specialist, Data Management
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What you'll do
- Serve as the primary owner of post-database lock final archive deliverables for multiple studies simultaneously.
- Identify, collect, verify, audit, and organize clinical trial documentation required for sponsor and site archives.
- Conduct initial archive audits and assess documentation completeness following formal archive requests.
- Create and maintain study-specific archive documentation and provide standard archive templates to project teams.
- Build and manage complex archive directory structures for both site and sponsor archive packages.
- Coordinate document acquisition activities and work closely with study teams to obtain outstanding closeout documentation.
- Support data generation activities, including study design acquisition, environment setup, reporting activities, and documentation review.
- Perform post-data generation processing activities and ensure archive contents meet quality and compliance requirements.
- Execute quality reviews of archive packages and associated documentation prior to final delivery.
- Prepare, package, upload, and coordinate delivery of completed archives through approved vendors and distribution channels.
- Communicate archive priorities, status updates, and delivery timelines with project teams, vendors, and internal stakeholders.
- Track archive shipments, coordinate delivery confirmations, and initiate archive decommissioning activities.
What they're looking for
- Minimum 2 to 5 years of Clinical Data Management, document management, records management, archives management, clinical operations, or related experience.
- Strong understanding of clinical trial documentation, study lifecycle activities, and regulated environments preferred.
- Demonstrated ability to independently manage projects and drive archive activities from initiation through completion.
- Exceptional organizational skills with the ability to manage multiple priorities and competing deadlines simultaneously.
- Proficiency with Microsoft Office applications, Adobe Acrobat, and collaboration tools.
- Strong attention to detail and commitment to quality, accuracy, and compliance.
- Excellent verbal and written communication skills, including the ability to communicate effectively in English.
- Proven ability to build relationships and collaborate effectively across departments and stakeholder groups.
- Strong problem-solving skills with the ability to identify issues and drive timely resolution.
- Ability to adapt quickly, shift priorities effectively, and perform successfully in deadline-driven environments.
- Customer-focused mindset with demonstrated responsiveness and accountability.
Nice to have
- Bachelor's degree preferred, or equivalent combination of education and relevant professional experience.
- Experience working with document management systems, electronic trial master files, archive repositories, or related platforms is preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Join Clario, a part of Thermo Fisher Scientific and help ensure the secure, accurate, and timely delivery of critical clinical trial documentation that supports global research programs. As an Archive Specialist within our Digital Physiology Data Management team, you will play a vital role in managing final study archives following database lock, ensuring study documentation is complete, organized, and compliant with customer and regulatory requirements. Working across multiple studies and collaborating with project teams throughout the organization, you will help drive operational excellence while supporting efficient study closeout activities and delivering an exceptional customer experience.
What We Offer
Competitive pay and incentives.
Provident fund and medical insurance.
Engaging employee programs and local events.
Modern office spaces and remote work flexibility.
What You'll Be Doing
Serve as the primary owner of post-database lock final archive deliverables for multiple studies simultaneously.
Identify, collect, verify, audit, and organize clinical trial documentation required for sponsor and site archives.
Conduct initial archive audits and assess documentation completeness following formal archive requests.
Create and maintain study-specific archive documentation and provide standard archive templates to project teams.
Build and manage complex archive directory structures for both site and sponsor archive packages.
Coordinate document acquisition activities and work closely with study teams to obtain outstanding closeout documentation.
Support data generation activities, including study design acquisition, environment setup, reporting activities, and documentation review.
Perform post-data generation processing activities and ensure archive contents meet quality and compliance requirements.
Execute quality reviews of archive packages and associated documentation prior to final delivery.
Prepare, package, upload, and coordinate delivery of completed archives through approved vendors and distribution channels.
Communicate archive priorities, status updates, and delivery timelines with project teams, vendors, and internal stakeholders.
Track archive shipments, coordinate delivery confirmations, and initiate archive decommissioning activities.
Perform quality checks on related archive deliverables and support cross-functional quality assurance activities.
Maintain archive metrics, dashboards, milestone trackers, and reporting tools on a daily, weekly, and monthly basis.
Support quarter-end archive planning activities to ensure delivery priorities align with business objectives and revenue targets.
Train and support team members and cross-functional partners on archive processes, documentation requirements, and best practices.
Participate in process improvement initiatives that enhance archive efficiency, documentation acquisition, and operational effectiveness.
What We Look For
Bachelor's degree preferred, or equivalent combination of education and relevant professional experience.
Minimum 2 to 5 years of Clinical Data Management, document management, records management, archives management, clinical operations, or related experience.
Strong understanding of clinical trial documentation, study lifecycle activities, and regulated environments preferred.
Demonstrated ability to independently manage projects and drive archive activities from initiation through completion.
Exceptional organizational skills with the ability to manage multiple priorities and competing deadlines simultaneously.
Experience working with document management systems, electronic trial master files, archive repositories, or related platforms is preferred.
Proficiency with Microsoft Office applications, Adobe Acrobat, and collaboration tools.
Strong attention to detail and commitment to quality, accuracy, and compliance.
Excellent verbal and written communication skills, including the ability to communicate effectively in English.
Proven ability to build relationships and collaborate effectively across departments and stakeholder groups.
Strong problem-solving skills with the ability to identify issues and drive timely resolution.
Ability to adapt quickly, shift priorities effectively, and perform successfully in deadline-driven environments.
Customer-focused mindset with demonstrated responsiveness and accountability.
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.
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