Global Study Director
Job
4314 AstraZeneca Pharmaceuticals LP Company
South San Francisco, CA (In Person)
Full-Time
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Job Description
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation
- ultimately providing employees with the opportunity to work across teams, functions and even the globe.
- Lead and coordinate a cross-functional study team to ensure clinical study progress according to timelines, budget, and quality standards.
- Contribute to vendor/ESP selection activities and lead operational oversight at the study level.
- Assist with operational planning for upcoming clinical studies, interfacing with cross-functional partners.
- Collaborate to establish strategies for increasing efficiency of global study teams.
- Facilitate communication across functions and provide guidance to study team members.
- Serve as the primary AZ contact for outsourced studies, ensuring delivery according to agreed standards.
- Hold accountability for essential study level documents development.
- Ensure external service providers perform to contracted goals and timelines.
- Develop and maintain relevant study plans, including risk management planning.
- Oversee study level performance against plans, milestones, and KPIs.
- Identify and report quality issues within the study and collaborate to overcome barriers.
- Ensure Trial Master File completion and compliance with governance controls.
- Manage study budget through lifecycle and provide progress reports.
- Ensure studies are inspection-ready at all times.
- Support professional development of team members.
- Provide guidance and mentoring to less experienced colleagues.
- Lead non-drug project work and improvement projects. Essential Skills/Experience
- University degree or equivalent in medical or biological sciences or discipline associated with clinical research.
- Proven project management experience and training.
- At least 7 years of clinical trial experience.
- At least 3 years of experience in global study leadership and team leadership.
- Demonstrated clinical trial expertise in hematology and/or oncology.
- Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements.
- Thorough understanding of the cross-functional clinical trial process.
- Strong strategic and critical thinking abilities.
- Proven skills in complex problem solving and decision-making.
- Strong abilities in establishing effective working relationships with senior stakeholders.
- Demonstrated abilities in mentoring.
- Excellent communication and interpersonal skills.
- Ability to manage multiple competing priorities.
- Experience in external provider oversight and management. Desirable Skills/Experience
- Advanced degree, masters level education or higher.
- Project management certification.
- 5 years of experience in global study leadership and team leadership.
- Significant hematology/oncology expertise.
- Expertise in different phases of clinical delivery.
- Experience with project management software solutions.
- Cell therapy/CAR-T experience.
- Global phase 3 study experience.
Our US Footprint:
Powering Scientific Innovation- YouTube The annual base pay (or hourly rate of compensation) for this position ranges from $162,566.
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