Exact Sciences

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Associate Clinical Study Manager

at Exact Sciences

Posted: 6/29/2018
Job Reference #: 2522
Keywords:

Job Description

  • Job LocationsUS-WI-Madison
    Req No.
    2018-2522
    Category
    Clinical Operations
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    This position will be part of the Clinical Affairs Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans. The Associate Clinical Study Manager manages, executes and reports on clinical study operations; and provides support to members of the multidisciplinary project team, internally and externally. The Associate Clinical Study Manager may work in conjunction with and/or with direction from a Clinical Study Manager.

    Essential Duties and Responsibilities

    • Act as a customer advocate throughout the project lifecycle
    • Understand and support global project goals including site recruitment, patient recruitment, marketing and PR, as appropriate
    • Implement approved clinical study Develops study-specific consent forms, and other trial related materials (e.g., Study Monitoring Plan, Patient Guide, Project Plan, etc.) as required
    • Coordinate with applicable cross-functional teams (e.g., R & D, Operations, Exact Sciences Laboratories) to identify goals and scope of clinical study projects; Manage and execute the overall project scope and timelines
    • Initiate and train sites to the study protocol; Ensure proper site adherence to clinical research regulations
    • Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, central IRBs, and contractual agreements
    • Support the management and oversight of CROs and other clinical study related vendors as applicable
    • Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device
    • Ensure maintenance of document standardization through the use of model documents, templates and appropriate peer review
    • Ensure the appropriate development of all documents by CROs including but not limited to: study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
    • Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies for study activities
    • Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required
    • Ensure operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed
    • Develop and maintain detailed timelines and resource projections for all programs
    • Prepare and distribute appropriate communications required to properly manage and document activities on the studies
    • Facilitate the completion of database development, statistical analysis and clinical study report writing
    • Manage relationships with consultants to provide adequate support and services for data collection and analysis
    • Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated
    • Attend off-site meetings and conferences as needed

    Qualifications

    Mandatory Skills

    • Clinical monitoring experience including data review/query resolution, protocol deviation tracking/trending, clinical site payment set-up/review and clinical sample management.
    • Experience writing, reviewing and editing protocols
    • Sample management system set-up experience. Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process including IDE, PMA, and 510(k)
    • Demonstrates problem-solving and interpersonal skills
    • Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects
    • Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff
    • Strong desire to work in a fast-paced environment
    • Ability to work independently and manage multiple timelines, while maintaining the team focus
    • Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email
    • Ability to exercise judgment and determine appropriate action for a wide range of issues of varying complexity
    • Ability to manage multiple deadlines

    Preferred Skills

    • Experience participating in the qualification and management of external vendors (e.g. CRO, Call Center, Central labs, etc.)
    • Experience contributing to project operational teams through the start-up, study conduct, and data management
    • International study experience and GDPR implementation

    Education and Experience

    • Bachelor’s degree in the life sciences or other applicable area
    • Minimum three years’ experience in clinical research with at least one year of clinical research experience with sponsor/CRO. Additional experience as a study coordinator or clinical research associate preferred

    Physical Requirements

    • Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day
    • Ability to sit and/or stand for an extended period
    • Ability and willingness to travel (by land and air), on occasion
    • Ability to lift and move up to 40 pounds on an occasional basis

    #LI-RM1

    Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program is available to any applicant or employee for inspection upon request.