ClinChoice · 6 hours ago
Senior Technical Document Operations Specialist
United States
Full-time
Remote
Mid, Senior Level
3+ years exp
Maximize your interview chancesBiotechnologyConsulting
Insider Connection @ClinChoice
Get 3x more responses when you reach out via email instead of LinkedIn.
Responsibilities
Assist Essential Document Management 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 Trial Master File Master List and within agreed upon Site Ready timelines.
Facilitate the archiving of Trial Master File documents received from other companies.
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>Trial Master File 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 to ASM.
Preparation and submission of ITFB Revision packages as needed, to ASM.
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 of REDS documents to Vault.
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
High School Diploma required
A minimum of 3 years as a Technical Document Operations Specialist and at least 4 years of relevant experience in clinical research
Must have knowledge of 'Essential' Clinical Trial Documentation
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
Preferred
Bachelor’s degree preferred
Familiarity with electronic Trial Master File system preferred
Company
ClinChoice
ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide.
1,001-5,000 employees
Funding
Current Stage
Late StageTotal Funding
$212MKey Investors
Legend CapitalGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C· Undisclosed
Leadership Team
John Balian, MD
Chief Executive Officer
Recent News
2023-07-18
Bloomberg.com
2023-07-07
2023-03-02
Company data provided by crunchbase
