Valeant Pharmaceuticals

  • Manager, Clinical Programs (Data Management)

    Location US-NC-Raleigh
    Job ID
    10133
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    This position is responsible for overall data management activities and deliverables of multiple clinical studies.  This position provides data management guidance to project team representatives on data management requirements.  This position is responsible for planning, preparing, conducting, and reporting assigned projects.

     

    This position will report to the Director, Clinical Data Management or higher. This role will supervise direct reports: Sr. Clinical Data Analysts, Clinical Data Analyst and/or Clinical Data Coordinator (as appropriate).

     

    Responsibilities

    • Ensure data management project time lines are met.
    • Manage all study specific data management activities and deliverables directly or through CROs and they may include, but not limited to CRF/eCRF design, DMP preparation, study database setup and validation, conducting data reviews, managing data discrepancies, preparing reports, coding reviews, performing SAE reconciliation, performing database lock, managing project documentation, preparing for regulatory submissions and audits, and study document archiving, .
    • Manage external vendors such as central laboratories, contract research organizations, EDC vendor, etc. 
    • Ensure SOP and guidelines related to data management are followed and maintained.
    • Maintain data management project documentation and overall responsibility for its content.
    • Represent the Clinical Data Management group in the project team meetings.
    • Conduct vendor qualification audits in compliance with SOP and regulations.
    • Provide project specific training to Clinical Data Management personnel.
    • Supervisory responsibility for professional and/or hourly staff.

    Qualifications

    • Must have a Bachelor’s degree with 5 to 7 years of experience in the Pharmaceutical, Biotech, Medical Device industry with 4 to 6 years in the data management arena. 
    • Minimum of 2 years of experience at the supervisory level. 
    • Ability to facilitate and manage operational activities that have been contracted out to third party vendors (CRO's, Labs, etc.). 
    • Strong understanding of regulatory requirements and guidelines.  Ability to work on a multi-disciplinary team and to contribute across multiple projects with competing priorities.
    • Demonstrated project management skills including proactive project planning.
    • Demonstrated leadership, decision-making ability, organizational skills and excellent verbal and written communications ability.
    • Strong analytical and problem solving skills
    • Broad interpersonal skills to interact with all levels of internal and external customers are necessary.

    Be Aware of Recruiting Fraud

    Valeant is an EEO/AA employer M/F/D/V.

     

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

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