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Clinical Data Manager

Supernus
Rockville, MD
  • Expired: November 17, 2022. Applications are no longer accepted.

Job Summary: To provide data management leadership, direction, strategy, and execution of clinical trials within Clinical Development. Essential Duties & Responsibilities * Maintains Data Management timelines and metrics. * Selects and manages Data Management vendor. * Coordinates User Acceptance Testing (UAT) and approves EDC databases. * Develops and oversees the Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs. * Oversees the development of Case Report Forms (electronic or paper) in collaboration with Biostatisticians and Clinical Research Associates, and approves final versions. * Oversees the development of edit checks and approving final versions. * Creates and maintains data management plans (DMP). * Oversees and leads data cleaning activities. * Participates in the review of clinical documents (e.g., protocols, case report forms, SAP). * Reconciles electronic data transfers from vendors. * Coordinates the archiving of study databases and related documents. * Writes SOP's and contributing to the improvement of Data Management processes. Non-Essential Duties & Responsibilities: * Attends and participates in internal and external training sessions. Supervisory Responsibilities: * May Supervise Clinical Data Associates as needed. Knowledge & Other Qualifications: * Bachelor's degree preferred but equivalent experience will be considered. * 5+ years of relevant data management experience. * Working knowledge of database applications. * Proficient with EDC technology (ex: RAVE, INFORM). * Working knowledge of industry standards such as CDISC, SDTM, and CDASH. * Data Manager Certification a plus. * Experience in CNS is preferred. * Budget forecasting/management a plus. * Understanding of regulations governing clinical research (i.e., FDA, Health Canada), and ICH GCP guidelines. * Strong organizational skills with attention to detail. * Excellent interpersonal and communication skills in English language (writing, speaking, and comprehending). * Computer literate with proficiency of Microsoft Office package including Word, Outlook, and Excel. Other Characteristics: * Ability to work independently and as part of a team. * Ability to maintain high ethical standards of integrity and quality. * Capable of performing other duties as assigned by management. * Capable of being innovative and dynamic in approach to work. * Authorized to legally work in the United States without visa sponsorship. Physical Requirements / Work Environment * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading * The worker is not substantially exposed to adverse environmental conditions Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Supernus

Address

Rockville, MD
20850 USA

Industry

Healthcare

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