WuXi AppTec

  • Project Director

    Job Locations US-TX-Austin
    Job ID
    2018-3889
  • Overview

    Oversee, manage and/or coordinate project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed.  Provide leadership as a senior member of the project management team.  Assist with the evaluation and implementation of systems and process to support efficient performance.  We strongly prefer this as an in-office position.

    Responsibilities

    • Provides operational support for Clinical Operations team.
    • Serve as Program or Project Director or Senior Project Manager for large or complex projects in order to assure applicable regulations, standard operating procedures and sponsor requirements are met.
    • Serve as escalation point of contact with sponsor for project or program related activities.
    • Serve as supervisor, resource, mentor, trainer and motivator to members of project or program team.
    • Oversee work of Project Managers including assessing quality, financial health, and customer relations.
    • Meet with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects.
    • Participate in business development activities as required, including proposal pricing and bid defense meetings.
    • Assist with development of systems and procedures for effective project management and clinical operations.
    • Perform training within company. 
    • Contributes to the overall operations and achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • May be required to assist in other departments

    Qualifications

    Experience / Education: 

    • 8 years of directly related clinical research experience in CRO, pharma, biotech/device company with 6 years of directly related project management experience including a minimum of 4 years supervising clinical and/or data project professionals.
    • Bachelor’s degree or HS diploma with commensurate experience. Graduate degree preferred.

     

    Knowledge / Skills / Abilities: 

    • Effectively communicates in clear, concise, professional manner with employees and senior management as well as with external peers and senior level customer contacts.
    • Proficient in oral and written communication skills
    • Proficient in Microsoft (Excel, Word, Outlook)
    • Knowledge of clinical trial management software products (e.g. CTMS, EDS, IVRS, eTMF, etc).
    • Excellent organizational and negotiation skills.
    • Good working knowledge of physician care in hospitals, clinics, or other healthcare settings.
    • Advanced knowledge of FDA guidelines, ICH, GCP, NDA, IND, and other applicable regulations.
    • Project management skills including client management, fiscal/contract management, and quality management.
    • Travel is required 10% , Domestic/International

     

    Physical Requirements:         

    • Must be able to work in an office environment, which has minimal noise conditions
    • Ability to stand or sit for most of the work day
    • Must be able to perform some activities with repetitive motion, such as keyboarding

     

    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

     

    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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