Senior Essential Document Specialist - RemoteMerck • Baton Rouge, Louisiana, United States
Senior Essential Document Specialist - Remote
Merck
- Baton Rouge, Louisiana, United States
- Baton Rouge, Louisiana, United States
À propos
Essential Document Specialist 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.
Interact with external partners for programmatic and functional sourcing.
Recognizes and considers various solutions to problems or situations.
Execution: 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.
Internal/External Interactions: 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.
Performance Tracking: Identifies and reviews metrics to assure process remains efficient and effective audit and Inspection Support: 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.
Education Requirements
Bachelor’s degree required.
Computer Skills
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
Experience
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.
Required Skills Adaptability, Clinical Documentation, Clinical Site Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, ICH GCP Guidelines, Inspection Readiness, Performance Tracking, Process Optimization
Location Restrictions US and Puerto Rico Residents Only. Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Salary $117,000.00 - $184,200.00
Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Compétences linguistiques
- English
Avis aux utilisateurs
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