Senior Manager, Clinical Project Lead at Alexion Pharmaceuticals


Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

This is what you will do:

The Senior Manager, Clinical Project Lead is accountable for the study team and study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The Senior Manager will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Senior Manager, CPL will provide status updates and performance metrics and develop, review, and approve related study documents.

You will be responsible for:

  • Under direct supervision of the Director CPL or Franchise Head, is accountable for the planning, implementation, and execution of clinical trials, including study deliverables, milestones, and data quality. Leads the Clinical Trial Team. Management oversight of CROs and relevant study vendors. Reports to the Director CPL or Franchise Head on trial metrics, issues, and rescue activities.
  • Managing CRO relationships to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget, and quality
  • Ensuring compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection.
  • Managing clinical study budgets within agreed variance.
  • 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, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts 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 exercise to help document continuous improvement process and sharing of best practices.
  • Participating in and/or lead departmental initiatives.

You will need to have:

  • >5 years of clinical research experience, 3 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.
  • 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:

  • PMP certification desirable

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Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .
Alexion 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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination requirement. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click .

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