Clinical Trial Document Specialist (440729)
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POST DATE 9/12/2016
END DATE 10/9/2016
Berkeley Township, NJ
JOB DESCRIPTIONJob Description:
Overview:The Clinical Trial Document Specialist is responsible for the end-to-end management of global electronic Trial Master Files (eTMFs), its content, records and associated processes in compliance with Client s policies, standards & procedures, Good Clinical & Documentation Practices (GCP & GDP), and federal regulations & international standards, as applicable.The Specialist actively participates as a critical study team member, reviews & approves eTMF content, or identifies and resolves issues using specific workflows & specified guidance, and collaborates with functional subject matter experts (SMEs) to identify, correct and reduce/prevent individual and systemic errors. Essential Job Functions:Accountability to study Project Managers, or equivalent, for assigned global eTMF responsibilities sponsored by a Core Client Division or International Business Center.Establishment and maintenance of a quality-focused partnership, with proactive provisioning of crucial TMF quality support to the study team from start-up to close-out.Provide real-time, constructive feedback, education and best practice demonstrations to promote user adoption and build a knowledge and awareness of GCP, GDP and associated processes.Oversee and manage essential document collection, including the timely and risk-based review and maintenance of eTMF content.Apply an integrative approach to eTMF quality management through efficient and judicious use of Clinical Trial Management System (CTMS), Oracle Remote Data Capture (RDC) and J-Review.Ensure documents are scanned, imported, classified and QC reviewed within eTMF on a daily / on-going basis.Conduct and/or assist in periodic inspection readiness exercises, internal audits and regulatory authority inspections.Represent Client in the TMF Reference Model Project Team, and become an active influence for medical device requirements on relevant initiatives and working groups.Assist in training internal and external team members on Client s TMF configuration(s) and eTMF process and procedures. Basic Qualifications:BS / BA / BSN or equivalent 4-year degree, preferably in a related scientific field. Associate degrees and technical certifications will be considered with strong, relevant prior experience.Thorough working knowledge of clinical trial methodology relating to the monitoring of clinical trials, GCP, FDA, and / or country specific regulatory environment1-3+ years of demonstrable, global TMF ownership spanning multiple indicationsExperience working with eTMF software platform(s)Experience working with Clinical Trial Management System(s)Experience working with EDC system(s)High to expert proficiency in MS Office Suite of productsExcellent interpersonal, administrative, verbal & written communication skills.Ability to work independently, at times with minimal supervision.Strong working knowledge of clinical trial design, execution and analysis methodologies.Ability to influence positive results in the absence of formally delegated authority or line management.Strong time management and prioritization skills to provide high quality deliverables while supporting multiple concurrent projects.Strong organizational skills, detail oriented. Additional Desirable Qualifications Skills And Knowledge:Medical DevicesVeeva Vault eTMF, Investigator Portal, Study Start-Up, Registrations, Submissions, QMS and/or Quality DocsBioClinica s OnPoint CTMSOracle RDCJ-Review Location: Murray Hill, NJ
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