ClinChoice · 6 hours ago
Senior Essential Document Specialist
United States
Full-time
Remote
Senior Level
5+ years exp
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Responsibilities
Support Essential Document Leads and Manager.
Support strategies, procedures, and tools for the optimization of the processes.
Applies creative solutions to complex site ready situations and demonstrates situational leadership within cross functional teams.
Recognizes and considers various solutions to problems or situations.
Works with internal/external partners to assure document processing times are maintained.
Monitors/tracks compliance of study essential documents.
Ensures the integrity of the essential clinical trial documents (both hardcopy and electronic) within the Official Regulatory files.
Ensures proper communication with external partners, stakeholders, and customers.
Liaises with clinical teams and external partners to achieve site ready timelines.
Interfaces with staff members to provide support and guidance.
Provide monthly/bi-monthly report on the Trial Master File Status for a study to ensure that the electronic Trial Master File is always Inspection Ready.
Responsible for creation and monthly maintenance of study Trial Master File Plans.
Assist with the Archival process to ensure all resolvable items have been addressed prior to final archival of a study.
Trial Master File review and reconciliation of study and site files to ensure completeness.
Essential Document review of the Trial Master File Plan.
Assist with the onboarding of new employees.
Identifies and reviews metrics to assure process remains efficient and effective.
Works with inspection support teams to ensure inspection process readiness.
Assists in retrieval of documentation during sponsor inspections.
Supports the development of responses to audits and inspections and ensures appropriate implementation.
Ensures that all actions and commitments are implemented in a timely manner.
Qualification
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Required
High School Diploma required; Bachelor’s degree preferred
A minimum of 3 years as an Essential Document Specialist and at least 5 years of relevant experience in clinical research.
General knowledge of ICH-GCP and other relevant regulations pertaining to essential documents.
Must have intermediate understanding of the functional area responsibilities associated with the clinical development process, trial management, and clinical trial management systems, as well as quality management and control tools.
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.
Demonstrated ability to manage multiple projects with varying deadlines is also required, support cross-functional teams of business professionals, analyze, interpret, and propose solutions to complex problems.
Working knowledge of electronic Trial Master File is required.
Intermediate level in Adobe Acrobat including knowing how to edit, extract and redact pages
Microsoft Office Suite 2010 or higher: Beginner to Intermediate experience level in WORD; Intermediate experience level in EXCEL; Intermediate experience level in Outlook.
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
