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CLINICAL DATA MANAGER

Supernus
Rockville, MD
  • Posted: over a month ago
  • Full-Time
Job Description
 

Job Summary: 

To provide data management leadership, direction, strategy, and execution of clinical trials.

Essential Duties & Responsibilities:

  • Leads all data management activities for one or more clinical trials.
  • Maintains and enforces Data Management timelines and metrics.
  • Selects and manages Data Management vendor.
  • Ensures quality database design, 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 the clinical team and approves final versions.
  • Oversees the development of edit checks and approves final versions.
  • Creates and maintains data management plans (DMP).
  • Oversees and leads data cleaning and coding activities.
  • Participates in the review of clinical documents (e.g., protocols, case report forms, SAPs, TLFs.
  • Reconciles electronic data transfers (e.g., clinical laboratories, SAEs) from vendors.
  • Coordinates the archiving of study databases and related documents in Trial Master File (TMF).
  • Writes SOP’s and contributing to the improvement of Data Management processes.
  • Other duties as assigned

Non-Essential Duties and Responsibilities:

  • Attends and may lead 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.
  • Nursing/medical/biology/ background will be a plus.
  • 5+ years of relevant data management experience in clinical trials.
  • Working knowledge of database applications.
  • Proficient with EDC technology (e.g., RAVE, INFORM).
  • Familiarity with MedDRA/WHO-Drug.
  • Working knowledge of industry standards such as CDISC (SDTM and CDASH).
  • Experience in CNS is preferred.
  • Budget forecasting/management a plus.
  • Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory guidelines.
  • Strong project and risk management with great 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 and maintain high ethical standards of integrity and quality.
  • Ability of having an innovative and dynamic approach to work.
  • A self-starter able to work independently but comfortable working in a team environment.
  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
  • Capable of performing other duties as assigned by Management.
  • Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements: 

  • 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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