CDC (20-00021) –

CLient:Supermus Pharmaceuticals
Location :MD
POsition :1 CDC II and 2 CDC III's

Job Summary The CDC II will work closely with the Clinical Data Manager (CDM) and Clinical Program Managers (CPM) to oversee data management activities performed by the designated data management vendor and core lab(s) with the purpose to deliver a clean and complete database for statistical analysis. Essential Duties & Responsibilities • Input in the development of the Data Management Plan (DMP), maintaining the DMP throughout the lifecycle of the study project ensuring that the DMP is followed according to study design and methodologies • Reviews and provides input to clinical protocol, Statistical Analysis Plan (SAP), and other documents collaborating with the biostatistician • Input in the development of the clinical database (DB), electronic Case Report Forms (eCRFs) and its implementation with study teams and electronic data capture (EDC) vendor(s) • Receive/Update data transfer agreements (DTA) between external data vendors and/or core labs • Advises study team on data management (DM) related aspects, seeks clarification on specific study needs, provides status/progress updates and highlights issues found during CRF review • Participates in data review meetings and clinical event adjudication meetings to discuss specific data values relevant for the analysis/determining subject populations • Maintains Data Validation Specifications (for computerized and manual checks), including testing edit checks and ensuring they are reviewed by the relevant team members • Acts as liaison for internal colleagues, as well as involved Clinical Research Organization (CRO) and other vendors to agree upon data management related timelines/issues • Perform, complete and provide accurate review of the clinical trial data, including resolution and clarification of any missing, inconsistent or clinically questionable data by the data manager, study team or sites • Participates in reconciliation of Serious Adverse Events (SAE) between Clinical and the Database • Generates/Incorporate study related metrics for study team • Participates in CRO evaluation to ensure organization is in alignment across all clinical programs • Liaise with the sponsor as required and communicate with management regarding all data management activities within their assigned studies • Participates in business development activities as required • Performs other duties and responsibilities as assigned Supervisory Responsibilities • N/A Knowledge & Other Qualifications • Bachelor's Degree preferred or equivalent experience. • Minimum of 2 plus years data management experience • Experience with EDC tools • Demonstrate knowledge of problem solving (queries, edit checks, etc.) and analytical skills • Experience working with CROs/EDC vendors for data management activities • Must have demonstrated knowledge of medical terminology • Must have knowledge of personal computers, database structures and database management software • Proficient with MS Word, Excel and Outlook • Strong organizational/communication skills (both verbal and written) required • Experience in interacting with all levels of management as well as with vendors/consultants • Ability to prepare documents, presentations, and excel analysis with minimal instruction • Positively and professionally represent Supernus and our Company values in all interactions both internally and externally • Must be highly organized • Flexibility and adaptability to organize and manage multiple projects and assignments and work with sense of urgency • Make sound judgments with independent decision-making, with the ability to proceed on own initiative where necessary and when needed • Adhere to regulatory guidelines, Good Clinical Practice (GCP) Standard Operating Procedures and client expectations • Ability to handle confidential matters and information with discretion and diplomacy and to have a security mindset Other Characteristics • Ability to work independently and as part of a team. • Capable of being innovative and dynamic in approach to work. • Authorized to legally work in the United States without visa sponsorship. • Ability to organize and prioritize, work independently and meet deadlines 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

Source: Job Diva – Job Listing

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