• Clinical Trial Lead

    Job Locations US-Remote
    Requisition ID
  • Responsibilities

    Provides leadership and day-to-day guidance to CROs and OPDC functional areas for assigned protocols. Interacts with expert physicians, investigators, vendor/CRO personnel, and functional area staff to ensure that the clinical protocol(s) are run according to ICH, FDA, and OPDC guidelines. Ensures compliance with FDA and international regulations, GCPs, and SOPs.


    • Acts as the operational lead for assigned domestic and global protocol(s).
    • Contributes to the development and implementation of study strategy.
    • Contributes to the development of protocol outlines, protocols, amendments, and Case Report Forms, as assigned.
    • Serves as primary CRO contact. Oversees the CRO in their conduct of the day-to-day operations of assigned protocol(s), including:
      • Development of ICFs and other study-related documents.
      • Coordination of local insurance policies.
      • Study planning, including Operations Manual and other planning documents.
      • Recruitment strategy.
      • Country and site selection.
      • Study-related tracking (enrollment, monitoring, regulatory documents, etc).
      • Trend analysis and risk mitigation.
    • Ensures accuracy and completeness of study-related tracking (enrollment, monitoring, regulatory documents, etc.). Provides study status information to Manager/Senior Manager/Associate Director Clinical Research.
    • Reviews and analyzes the data from tables and listings. Trains the CRO in OPDC data review processes and proper recording and management of findings.
    • Contributes to Clinical Study Reports, as assigned.
    • Acts as a resource to the CRO staff to identify problems and propose solutions to maintain projects within designated timelines and budgets.
    • Responsible for the quality of the preparation, presentation, issue identification, and follow-up for all portions of investigator meetings.
    • Co-ordinates training programs for study staff and CROs prior and during study conduct.
    • Communicates and coordinates study-related activities across all relevant cross-functional areas.
    • Ensures that assigned studies are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements.
    • Reviews and approves Oversight Reports; familiar with trends.
    • Conducts Monitoring Oversight Visits. May serve in the Clinical Quality Lead role for Early Phase or other protocols with small numbers of sites.
    • Approves selection of appropriate clinical staff by the CRO.
    • Ensures smooth communication and interaction on project-related activities.
    • Provides ongoing analysis, interpretation, and presentation of data.
    • Participates in process and continuous improvement initiatives as assigned.


    Knowledge: Comprehensive knowledge of clinical operations; thorough knowledge of the drug development process, roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations, contract research organizations, outsourcing, and evaluation of work perfomed against vendor Statement of Work. Understanding of the clinical and scientific basis for assigned protocols.


    Skills: Strong communication, organization, planning, analytical, problem solving, and people management skills. Demonstrated experience with working with the Microsoft suite of programs (Word, Excel, Powerpoint, Outlook). Good understanding of clinical trial related software (eCRFs, IWRS, CTMS).


    Required: Bachelor’s degree in a health science field, or nursing degree. Minimum of 5 years in the pharmaceutical industry and 4 years clinical trial management or monitoring experience.


    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.

    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.



    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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