Proclinical is currently seeking an eTMF Specialist for a pharmaceutical company located in Boston, MA. Successful candidate will provide support and assistance to Clinical Operations team members and functional areas outside of Medical Development in the management of study eTMF's and expected documents.
- Assist with implementing the established processes for TMF activities by liaising with the study teams and relevant CRO team members.
- Collaborate with cross functional teams to facilitate knowledge and use of TMF tools and existing processes.
- Assist with tracking, review and mitigation of TMF inventory gaps for ongoing and new Clinical studies.
- Support daily management of activities including but not limited to eTMF system tasks, tracking TMF shipments and offsite archival.
- Assist with Inspection Readiness preparation activities related to TMF in compliance with applicable laws and regulations.
- Conduct quality reviews of eTMF across Clinical studies as needed. Work closely with the study teams and CRO's to resolve and mitigate any TMF related findings.
- Perform final quality reviews as needed to ensure a complete study eTMF. Assist with study archival planning and related activities.
- Assist with CTMS system tasks including but not limited to data entry, running reports and dashboards.
- Track storage of archived records and TMF shipments from CRO's and sites as applicable.
- Provide support to TMF Operations during audits and/or regulatory Inspections.
- Adhere to TMF SOP's and other relevant TMF process supporting guidance's.
Skills and Requirements:
- BA/BS or equivalent level of qualification in Life Sciences, Pharmacy, Nursing or related field.
- 3+ years of clinical research experience with 2+ years of relevant document management, quality content reviews and completeness review experience.
- Must have the knowledge of TMF Reference Model, Good documentation practices and GCP.
- Must have ability to navigate across multiple studies in the eTMF system with proficiency in Word, Excel and PowerPoint.
- Must be proactive, self-motivated and able to work independently with minimal supervision.
- Familiarity with working in eTMF applications, preferably Veeva Vault.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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