Manager/Associate Director, Clinical Data Management (Scranton,PA)
: $105,360.00 - $158,170.00 /year *
: Scientific Research
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The Manager/Associate Director, Clinical Data Managementposition offers an opportunity to join a small group of highly-experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market. This is a full-time position at the University City Science Center, Philadelphia, PA. Responsibilities: Develop clinical data management plans including key study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution) for multiple clinical trials, including both company-sponsored and investigator-initiated studiesOversight of data management CRO/service providers on assigned studiesMonitor the progress of all data management activities on assigned studies to ensure project timelines are met.Provides training on the CRF completion guidelines and EDC system at Initiation Visits and to internal or external team members, as needed. Serve as main point of contact with clinical sites for data-management related mattersProactively identifie potential study issues/risks and recommends/implements solutionsResponsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goalsProvide Data Management support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverablesTrack and provide status updates on data management at regular team meetingsQC review of clinical manuscripts, regulatory documents, and clinical protocols/ICF to ensure consistency with current clinical databaseEstablish systems and procedures required for a typical FDA audit on clinical programs Requirements:Bachelor ??s degree, preferably in a science-related fieldAt least eight years of clinical data management experience with a preference for oncology trials and familiarity with both industry-sponsored and investigator-initiated trials Demonstrated experience with developing data capture and management systems for new clinical trials (designing CRFs/eCRFs, edit checks, CRF completion guidelines, etc.) in a Pharmaceutical/Biotech/CRO environment.Knowledge of industry standards (CDISC, SDTM, CDASH)Strong technical skills in various EDC systems, plus MS Word, Excel, PowerPoint, etc.Forward-thinking with the ability to anticipate challenges and proactively implement solutionsStrong attention to detail with exceptional written and verbal communication Team player who is highly organized and efficient and can operate without the support of a team typical in large pharma by Jobble Associated topics: antibody, aseptic technique, dietician, drug development, healthcare, immunohematology, immunology, kinesiology, therapy, trauma Associated topics: dietary, histotechnologist, immunohematology, kinesiology, medicine, microbiological, microbiology, physiologist, physiology, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.