Regulatory Documentation Specialist
1 year contract with possible renewal
TMF Specialist - Global Regulatory Operations Department
Remote position - up to 40 hrs week
Responsible for performing global management activities relating to electronic and paper Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.
Functions may include, but not limited too; eTMF system set-up and maintenance, creation/management of TMF Plan and filing expectations; eTMF query resolution, eTMF user support, and assisting with the oversight of the eTMF vendor; performing quality control reviews of TMFs to ensure they adhere to SOPs and meet regulatory requirements and ICH guidelines.
This role will be required to work collaboratively across functional areas and contribute to positive team relationships, both locally and globally.
• Conduct Quality Control reviews of TMF Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents and conduct eTMF query resolution.
• Assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; Maintain electronic logs which contain the location of study documents.
• Development/Contribution toward user manuals / Best Practice guides
• Must have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines.
• Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.
• eTMF/TMF Process and system training
• eTMF Implementation experience
• Ability to think outside the box
• Hands on Inspection experience (FDA, MHRA, etc)
• Internal audit preparation
• Support integration of partnered or clinical information including transfer of TMFs in compliance with applicable regulations and best practice
• Proactively stay current with best practices and recommends application across business groups to improve TMF operations
• Assist with TMF process education
• Assist CRO eTMF configuration
• Assist and deliver key KPI reports to study team, manage expectations, and track on-going kpi across all study team by partnering with clinical operations leads
• Working knowledge of Microsoft Word, Microsoft Excel, Adobe Acrobat, and electronic document management systems, preferably Documentum. Agility with ClinOps databases preferred.
• Basic knowledge of CFR, GCP & ICH Guidelines.
2 plus years Pharma experience (includes CRO / Vendor experience)
• Knowledge and understanding of DIA TMF Reference model
• Excellent written, verbal, and interpersonal communication skills.
Bachelor’s Degree preferred.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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