Job Description

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, partering with our Country Operations Management teams, overseeing CROs as needed and proactively managing 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.

Job Duties & Responsibilities

• Under direct supervision of the Director CPL, the Senior Manager CPL is accountable for the planning, implementation and execution of clinical trials, including study deliverables, milestones and data quality. Leads the Clinical Trial Team. Provides management oversight of CROs as needed and relevant study vendors. Reports to the Director CPL on trial metrics, issues, and rescue activities.
• Partners with our Country Operations Management teams to deliver studies in an insourced model and manages CRO relationships as needed 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
• Ensures compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection.
• Manages clinical study budgets within agreed variance.
• Communicates clinical studies performance data to other members of the management and scientific team.
• Prepares and maintains 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.
• Conducts lessons learned exercise to help document continuous improvement process and sharing of best practices.
• Participates in and/or lead departmental initiatives.

Essential Qualifications

5 years of clinical research experience, 3 of which in a leading role accountable for the planning and execution of global clinical trials. * Bachelor\xe2\x80\x99s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.

Preferred Qualifications

• PMP certification desirable.

#LI-Hybrid

Date Posted 18-Jul-2023

Closing Date 10-Jul-2023

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 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.

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