C. R. Bard, Inc.

  • Sr. Manager, Clinical Sciences

    Posted Date 2 weeks ago(7/10/2018 3:44 PM)
    Job ID
    2018-11797
    Career Level
    management
    Division
    BDI Corporate
    Relocation
    No
    Location
    US-GA-Covington
  • Summary of Position with General Responsibilities

    The Senior Manager, Clinical Sciences applies a broad knowledge of clinical research activity, therapeutic area knowledge and regulatory requirements to facilitate the development, implementation and dissemination of clinical studies. The primary objective and purpose of this position is to ensure that clinical trials are designed to meet the regulatory and business needs of the responsible Business Unit and that study documents (i.e., protocols, study reports) are developed with scientific rigor. He / she leads others in all aspects of clinical science including research, developing and writing study protocols, investigator brochures, study summaries, clinical study reports, or other clinical documents. Additionally, he / she and team will assist Medical Affairs in Business Units in developing clinical strategies and executing publication strategies.  The Senior Manager, Clinical Sciences will review study protocols as requested or required and may be asked to respond or provide guidance  regarding scientific and related procedural issues from investigators. He / she will oversee one or more medical writers who will provide timely and accurate completion of medical writing deliverables.    

     

    The position works closely with Medical Affairs at Business Units, Principal Investigators and statisticians to develop clinical documents. He / she may present or assist with preparing responses to regulators or present data to data monitoring committees, investigators, etc. 

    Additionally,   he/she will collaborate and facilitate discussions with internal partners such as Health Economic & Outcomes Research, Global Health, Digital Health and others.

    Essential Job Functions

    • Works with GCD Functional Groups and Business Unit Medical Affairs and HEOR to define clinical strategy in support of business objectives;
    • Conducts and oversees background research on indications and studies to establish references and scientific base;
    • Utilizes knowledge of clinical trial design to develop specific study concepts and protocols;
    • Participates and leads discussions concerning scientific and procedural aspects of study design;
    • Develops and/or oversees the development of clinical documents (study protocol, investigator brochures, consent forms, study reports, etc.) in accordance with regulatory requirement;
    • Provides input to the design of CRFs;
    • Identifies and resolves issues related to study design and execution;
    • Prepares/writes and reviews/edits regulatory documents and responses to regulatory authorities (e.g., Notified Bodies, FDA, etc.) as it relates to BD-sponsored studies and/or clinical evidence;
    • Plans, drafts and revises scientific manuscripts for publication;
    • Writes and presents abstracts describing study data for clinical conferences;
    • Supports Key Opinion Leader (KOL) development activities as needed.
    • Helps develop policy and assumes the Administrator’s role for compliance with clinical trials registration to meet US and other regional laws and regulations
    • Identifies best practices for study design and execution, updates SOPs and templates accordingly, and provide training sessions for appropriate personnel;
    • Leads and develops a team of clinical scientists to support business needs;

    Basic Qualifications

    • Minimum of BS or equivalent, MS, MPH, PharmD or PhD in field relevant to clinical research preferred
    • Experience in clinical medicine setting, e.g., laboratory, hospital research unit
    • Minimum 3 years with PharmD or Ph.D, 5 years with MS or MPH and 8 years with BS.
    • Minimum 3 years supervisory experience.
    • Must be able to use scientific and clinical knowledge to conceptualize study designs
    • Must demonstrate excellent writing and organizational management abilities
    • Familiar with clinical operations and FDA and HIPAA rules, regulations and guidelines 
    • Knowledge of good document management practices

    Additional Desirable Qualifications Skills and Knowledge

    • Ability to anticipate and resolve problems
    • Ability to lead cross functional efforts and teams
    • Proficiency in data interpretation
    • Clinical project management skills
    • Excellent skills in oral and written communications
    • Ability to work independently with minimal guidance as well as collaboratively within a team setting

     

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