Technical Document Operations Specialist

Clinchoice - Pennsylvania Furnace, PA

Full-time - Entry Level

Pennsylvania Furnace, PA

1,001-5,000 employees

Administrative and Support Services

About the position

The Technical Document Operations Specialist at ClinChoice is a permanent, remote role focused on supporting clinical trials by managing essential documentation and ensuring compliance with regulatory standards. This position involves working closely with a large pharmaceutical company and requires strong organizational skills, attention to detail, and the ability to work independently while fostering a high-trust environment with clients.

Responsibilities

• Assist Essential Document Manager in the maintenance of the Trial Master File.
• Process applicable emails within the Site Initiation, Clinical Clearinghouse, and Technical Document Operation inquiries.
• Facilitate the archiving of Trial Master File documents received from other companies.
• Follow up with CRO and the Record Center to ensure documents are archived appropriately and timely.
• Process Safety Reports and recall study documentation from archives as needed.
• Conduct ongoing REDS>TMF Reconciliation and provide audit and inspection support as needed.
• Prepare general templates for Site Binders and negotiate study-specific binder templates with the clinical team.
• Create physical binders per site or submission and prepare revision packages.
• Conduct User Acceptance Testing as requested and attend meetings with Essential Document Management and clinical teams.
• Maintain binder and document processing metrics and tracking, including unblinded document processing.
• Assist with Merger & Acquisition related tasks and address legal requests as needed.

Requirements

• High School Diploma required; Bachelor's degree preferred.
• 1 year of experience working in Clinical Research.
• Knowledge of essential Clinical Trial Documentation and familiarity with electronic Trial Master File systems preferred.
• Strong verbal, written, and organizational skills with a team-oriented approach.
• Strong time management skills and detail-oriented.
• Self-motivated with the ability to handle and prioritize multiple tasks to meet deadlines.
• Excellent English communication skills (oral and written).
• Proficient in Adobe Acrobat and Microsoft Office Suite, including Word, Excel, and Outlook.

Benefits

• Competitive salary
• Remote work flexibility
• Professional development opportunities
• Supportive company culture