Specialist Study Management

Wilmington, DEContract Duration: 12-36 monthsRate: NegotiableSalary: NA $1.00Responsibilities:Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area.Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.Support the CRA in the maintenance and close out activities for the ISF.Contribute to the production and maintenance of study documents, ensuring template and version compliance.Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the company Authoring Guide for Regulatory Documents to support publishing in GELContribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).Set-up, populate and accurately maintain information in company tracking and communication tools (e.g. IMPACT, SharePoint etc.) and support others in the usage of these systemsExperience:Bachelor's degree is preferred3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents is requiredVeeva experience a plusAccountable and inquisitive; thinks "outside the box"Must be methodical, compliant to processes yet flexible when neededIndependent yet able to work cohesively with a teamCandidates must be local to Wilmington, DE; non-remote positionExperience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelinesWorking knowledge of clinical study documentsAbility to develop advanced computer skills to increase efficiency in day-to-day tasksGood verbal and written communicationWillingness and ability to train others on study administration proceduresDisplay excellent organization and time management skills