Clinical Data Manager

Clinical Data Manager100% RemoteCONTRACTHit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.Provide leadership for clinical data management function; ensure data management deliverables are completed on time, within budget and in accordance with quality standards and study requirementsResponsible for leading end-to-end data management activities for late phase clinical trial(s); responsible for the oversight of CRO and/or DM vendors to ensure that project goals are achieved and overseeing adherence to scope of work and service agreementsRepresent data management in Study Management Team (SMT) meetings; proactively identify and communicate risks, suggest solutions and provide updatesEstablish and maintain strong relationships with cross-functional teams, vendors and key stakeholders for successful execution of clinical trialCollaborate with study statistician and statistical programmer to support production of clinical trial reports and other study deliverablesDevelop and maintain study-specific DM documents (e.g., electronic Case Report Form (eCRF) completion guidelines, annotated CRFs, CRF and data validation specifications, data transfer agreements, data management plan and data review plan)Lead and oversee Electronic Data Capture (EDC) build, modifications and deployment including creation and execution of User Acceptance Testing (UAT) plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., Interactive Response Technology (IRT)); develop and maintain EDC build/modification timelinesMaintain study DM related documents for inspection readinessDevelop data transfer agreements with external vendorsReview and provide feedback on clinical documents (e.g., clinical protocols, statistical analysis plans, protocol deviation plans, vendor specifications)Report data management metrics and trends; proactively identify barriers to timely and successful trial execution and propose solutionsLead clinical data review of data listings, external data reconciliation reports, SAE reconciliation and implement data review strategyServe as a subject matter expert on data management systems and processesContributes to the development and improvement of data management standard operating procedures (SOPs) and document templatesRequirements:Bachelors in life sciences or related discipline with 8 or more years of experience in clinical data managementZelta experience RequiredRequires extensive knowledge of clinical data management principles, clinical trials process and regulatory requirementsExcellent ability to manage competing priorities in a changing environmentStrong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelinesProficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardizationSelf-motivated and takes pride in your workResults-oriented team player; enjoy working collaboratively with colleagues and building positive relationshipsAttention to detail, ability to proactively identify issues and address with solutions-oriented approachBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser:

of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. xhyhwjd This form will be used for reporting purposes only and will be kept separate from all other records."