Senior Clinical Data Associate

Position SummaryThe Senior Clinical Data Associate provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position may perform database development and testing, as well as additional data management activities.Essential functions of the job include but are not limited to:Support the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely mannerMay perform data entry for paper-CRF studies, as neededMay perform quality control of data entryMay provide input into timelines. Ensure that clinical data management deadlines are met with quality. May assess resource needs for assigned projects, as needed.Assist in developing CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholdersMay assist in building clinical databasesConduct database build UAT and maintain quality controlled database build documentation. May oversee overall quality of the clinical database.Assist in specifying requirements for all edit check types e.g., electronic, manual data review, edit checks, etc.Responsible for creating, revising, appropriate versioning and maintaining data management documentation.Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.Review and query clinical trial data according to the Data Management PlanPerform line listing data review based on the guidance provided by the sponsor and/or Lead DMRun patient and study level status and metric reportingPerform medical coding of medical terms relative to each other in order to ensure medical logic and consistencyAssist with coordinating SAE/AE reconciliationAssist with liaising with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverablesMay assist with SAS programming and quality control of SAS programs used in the Data Management departmentIdentify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholdersMay assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the projectMay assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activitiesTrains and ensures that all data management project team members have been sufficiently trainedCommunicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issuesMay present software demonstrations/trainings, department/company training sessions, present at project meetingsMay require some travelPerform other duties as assigned.QualificationsMinimum Required:5+ years’ experienceBachelor's and/or a combination of related experience Other RequiredProficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.Able to handle a variety of clinical research tasks.Excellent organizational and communication skillsProfessional use of the English language; both written and oral.Basic knowledge of drug, device and/or biologic development and effective data management practices.PreferredExperience in a clinical, scientific or healthcare discipline.Dictionary medical coding (MedDRA and WHODrug)Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)Oncology and/or Orphan Drug therapeutic experienceSkillsDemonstrates strong knowledge of ICH-GCP, relevant Precision Oncology SOPs, and regulatory guidance, as well as the ability to implement and drive outcomesCompetenciesMotivates project team members to meet timelines and project goalsFocuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effectiveResolves project related problems and prioritizes workload to meet deadlines with minimal supportExhibits a high degree of self-motivation, and can work and plan independently as well as in a team environmentDemonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skillsAny data provided as a part of this application will be stored in accordance with our Privacy Policy. 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