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.Associate Director, Clinical Project LeadLocation: Barcelona, ESThis is what you will do:The Associate Director, Clinical Project Lead is responsible for leading the Cross-Functional Clinical Sub-Teams to define study specifications, achieve study milestones through operational feasibility, budget and timeline estimates, and operational accountability and management of study deliverables.
This role serves as 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 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:Accountable for the planning, implementation, and execution of pivotal clinical trials, including study deliverables, milestones, and data quality.
Leads the Clinical Trial Team.
Management oversight of CROs and relevant study vendors.Oversee third-party vendors to operationalize these study specifications.Direct 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.Accountable for planning, tracking, and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals.
Develop and maintain 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.Manage CRO relationships to ensure the appropriate scope of work, oversight and training of clinical investigators, and achievement of study milestones within agreed-upon timelines and budget.Communicate clinical studies performance data to other members of the management and scientific team.Prepare and maintain 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.Conduct lessons learned exercises to provide continuous process improvement and sharing of best practices.Participate 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.AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease.
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