Senior Manager, Clinical Project Lead
2 weeks ago
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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, partnering 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.
You will be responsible for:
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 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.
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 nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
PMP certification desirable.
At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.
Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.
#LI-Hybrid
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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