Archive Technical Specialist

Company: Clario. The Best of ERT & Bioclinica
Location: Remote
Posted on: January 24, 2023

Job Description:

The Archive Technical Specialist is responsible for every phase of the EPX archive deliverable, as well as assisting with the production of the StudyWorks archive deliverable. This includes modifying the VBA and Python Data Generation programs as necessary for the EPX Data Generation. Additionally, the Archive Specialist assists the Lead Archive Manager with the Data Generation process for the StudyWorks archives, and provides ad-hoc SQL.ESSENTIAL DUTIES AND RESPONSIBILITIES:

EPX Archives:

Perform DB lock upon Data Manager request.


Perform Data Generation by running/updating the various Python and VBA programs.


Writing the SQL "webtags".


Perform Post Data Generation processes prior to upload to vendor.


After quality check, zip and upload the completed archive to the shipping vendor and communicate with the vendor to inform of priority and any other archive specific details that the vendor will need.


Follow up with the shipping vendor to acquire tracking, forwarding the tracking to the study team.---





StudyWorks Archives:

Identify, locate, collect, verify, and organize trial documentation.


Perform initial document audits upon formal archive request.


Provide templates of standard Archive documents to the Study Team and create multiple study specific documents for inclusion in the archive.


Set up the complex directory structure required by both the Site and Sponsor portions of the archive and place the acquired documents in the appropriate folders in both Site and Sponsor portions of the archive.


Identify, locate, collect, verify, and organize trial documentation.


Assist the Lead Archive Manager with Data Generation such as acquisition of the Study Design, setup of the required environment on one of the data generation servers, running the missing DCR check report, and generating the appropriate emails based on the results.


Provide Data Generation Certification.


Provide ad-hoc SQL reports to the Lead Archive Manager on an as needed basis.


Weekly emails to Project Management team to request outstanding documentation.


Perform Post Data Generation processing after Data Generation is handed off by the Lead Archive Manager.


After quality check, zip and upload the completed archive to the shipping vendor and communicate with the vendor to inform of priority and any other archive specific details that the vendor will need.


Follow up with the shipping vendor to acquire tracking, forwarding the tracking to the study team, and initiating the "Notice of Archive Delivery" email.


Manage and update Archive Metrics and SmartSheet milestones on a daily, weekly, and monthly basis


During quarter end advise the Lead Archive Manager as the status of each archive changes so that the priorities and focus can constantly be on the archives that have the best chance to ship for the current quarter.


Build and maintain excellent working relationships with other teams to ensure cooperation with document acquisition.


Provide a transfer of knowledge to various teams (when necessary) in order to facilitate a better turnaround time for the documentation acquisition. This could include, but is not limited to, training sessions, meetings, and very detailed email instructions including screen shots and examples.


Adhere to revenue generating priorities and timelines. Multi-task and shift focus quickly, especially during the final 2 weeks of each quarter to ensure maximum revenue.





OTHER DUTIES AND RESPONSIBILITIES:

During quarter end advise the Lead Archive Manager as the status of each archive changes so that the priorities and focus can constantly be on the archives that have the best chance to ship for the current quarter.


Build and maintain excellent working relationships with other teams to ensure cooperation with document acquisition.


Provide a transfer of knowledge to various teams (when necessary) in order to facilitate a better turnaround time for the documentation acquisition. This could include, but is not limited to, training sessions, meetings, and very detailed email instructions including screen shots and examples.


Adhere to revenue generating priorities and timelines. Multi-task and shift focus quickly, especially during the final 2 weeks of each quarter to ensure maximum revenue.



QUALIFICATIONS AND SKILLS NEEDED:

(Key wording should include if degree is needed, any travel requirements, special qualifications needed, skills, etc.)

Education:

BS/BA degree in Computer Science or related field preferred.



Experience:

Proficient in Microsoft Office applications and Adobe Acrobat.


Ability to manage multiple priorities and to switch focus seamlessly.


Excellent communication skills and the ability to work well with others.


A commitment to meet deadlines with a keen focus on details.


Ability to communicate effectively in English.



The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

Keywords: Clario. The Best of ERT & Bioclinica, Eugene , Archive Technical Specialist, IT / Software / Systems , Remote, Oregon