Technical Document Operations Specialist

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Technical Document Operations Specialist to join one of our partner companies a large pharmaceutical company in USA. This is a permanent remote role.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Main Job Tasks and Responsibilities:

• Assist Essential Document Manager in the maintenance of the Trial Master File.

• Process applicable emails within the Site Initiation Clinical Clearinghouse Technical Document Operation Specialist USA inquiries and Restricted Mailboxes in accordance with the TMF Master List.

• Facilitate the archiving of Trial Master File documents received from other companies including the review of inventory spreadsheets and DVDs/CDs/USBs/Hard Drives received from other companies.

• Follow Up with CRO and the Record Center as needed throughout the process to ensure documents are archived appropriately and in a timely fashion.

• Safety Report processing.

• Recall study documentation from archive as needed review contents as instructed and return study documentation to archive in a timely fashion.

• Ongoing REDS>TMF Reconciliation.

• Audit and Inspection support as needed.

• Site Binders:

• General template preparation prior to clinical team review.

  • Study specific binder template negotiation with clinical team.

  • Physical creation of binder(s) per site or submission.

  • Preparation and submission of Revision packages.

• User Acceptance Testing as requested.

• Attend meetings with Essential Document Management and/or clinical teams as needed.

• Maintain binder and document processing metrics and tracking.

• Unblinded document processing.

• Assist with Merger & Acquisition related tasks including meeting attendance.

• Address Legal requests as needed.

• Assist with Site Retention related tasks.

• Processing documents to Vault.

Education and Experience:

• High School Diploma required but Bachelor’s degree preferred.

• 1 year of experience working in Clinical Research.

• Must have knowledge of “Essential” Clinical Trial Documentation. Familiarity with electronic Trial Master File system preferred.

• Strong verbal written and organizational skills with a team-oriented approach as well as works well independently.

• Strong time management skills.

• Detail oriented.

• Self-motivated.

• Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.

• Excellent English communication skills (oral and written).

• Proficient in Adobe Acrobat and Microsoft Office Suite including (but not limited to) Word Excel and Outlook.

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step.  Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

Key words: Technical Document Operations Specialist Clinical Trials ICH-GCP eTMF Microsoft Office CRO Contract Research Organization Outsourced Outsourcing Sponsor-dedicated.

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