Regulatory Documentation Specialist
TMF Specialist - Global Regulatory Operations Department
On-site position - up to 40 hrs week
• Perform daily Trial Master File management activities such as Review, Processing, Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready.
• 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.
• 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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