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    Associate Director, Clinical Project Lead - Boston, United States - Alexion Pharmaceuticals

    Alexion Pharmaceuticals
    Alexion Pharmaceuticals Boston, United States

    1 week ago

    Default job background
    Full time
    Description

    Associate Director, Clinical Project Lead

    This is what you will do:

    The Associate Director, Clinical Project Lead is responsible to lead the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility and budget and timeline estimates and operational accountability and management of study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Associate Director, CPL may be accountable for setting and managing operations across multiple studies and may be a member of the Core Team depending on the scope of the project.

    You will be responsible for:

  • Planning, implementing, and executing pivotal clinical trials, including study deliverables, milestones, and data quality. Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors.
  • Overseeing third party vendors to operationalize these study specifications.
  • Directing the operational execution of clinical study activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection.
  • Planning, tracking, and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Developing and maintaining budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
  • Managing CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and achievement of study milestones within agreed upon timelines and budget.
  • Communicating clinical studies performance data to other members of the management and scientific team.
  • Preparing and maintaining required study and regulatory documentation, e.g.: reports for Competent Authority submissions, master patient informed consent, Monitoring Plan, Pharmacy Manual, Investigator Agreements, and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.
  • Conducting lessons learned exercises to provide continuous process improvement and sharing of best practices.
  • Participating in and/or lead departmental initiatives.

    • You will need to have:

  • > 10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials.
  • Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
  • Ability to lead cross-functional teams and to provide management oversight of CROs.
  • Experience in developing study budgets, forecasting and financial oversight of a project.
  • The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

    • We would prefer for you to have:

  • Advanced degree (Master, PhD, MD) is desirable.
  • PMP certification desirable.

    • Date Posted

    04-Apr-2024

    Closing Date

    30-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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