Global Study Associate Director

AstraZeneca • Boston, MA

84d

About The Position

As a Global Study Associate Director (GSAD), you'll play a pivotal role in steering cross-functional study teams towards success. Your leadership will ensure that studies are delivered on time, within budget, and to the highest quality standards. Be at the forefront, guiding your team through the complexities of clinical trials across various therapeutic areas and phases. With your expertise, you'll navigate regulations, policies, and standard methodologies to achieve Alexion's mission and values.

Requirements

• Bachelor’s degree or equivalent in fields related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
• 7 years of clinical research experience, 2 of which in a leading role accountable for planning and execution of global clinical trials.
• Clinical research regulatory requirements and proven success in clinical study management processes.
• Strong skills in team leadership.
• Strong abilities in establishing effective working relationships with internal and external co-workers and partners.
• Excellent communication and interpersonal skills.
• Strong strategic and critical thinking abilities.
• Strong organizational and problem-solving skills.
• Ability to manage competing priorities.

Nice To Haves

• Masters or Ph.D.
• PMP certification.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure clinical study progress as planned, driving achievement of benchmarks according to timelines, budget, and quality standards.
• Develop and maintain relevant study documents/plans including input into clinical study protocol, clinical study report, and study level quality and risk management planning.
• Facilitate communication across all functions and provide mentorship and support to the core and extended study team members.
• Serve as the main point of contact for the Global Project Team (GPT) and the Clinical Sub-Team (CST).
• Maintain study tracking systems and project timelines, presenting risks to timelines and/or quality along with proposed mitigations.
• Lead all aspects of TMF completion in accordance with relevant SOPs, ensuring ongoing QC activities for TMF completeness.
• Ensure timely compliance with company-wide governance controls.
• Ensure studies are inspection-ready at all times, serving as the primary Clinical Operations point-of-contact during audits or inspections.
• For outsourced studies, act as the primary Alexion point of contact for the CRO Project Manager to ensure study delivery according to agreed timelines, budget, and quality standards.
• Ensure all external service providers engaged at the study level are performing to contracted goals and timelines/budget.
• Accountable for planning, tracking, and forecasting the Global Clinical Operations budget and timelines for studies against agreed goals.
• Delegate and manage team member responsibilities.
• Conduct lessons learned exercises for continuous process improvement.
• Work on non-drug project work such as Clinical Operations representative in process improvements or leading improvement projects.
• Collaborate with global and country teams to determine appropriate country footprint for the study.
• Lead Key External Expert (KEE) outreach activities to assess study design suitability or find opportunities for protocol improvement.
• Partner closely with Strategic Feasibility to develop country and site footprint proposals and patient enrolment projections.
• Maintain global oversight of study deliverables, achievements, and site monitoring throughout the study lifecycle.
• Work with global and country-level collaborators to mitigate risks or issues related to site management and monitoring.

Benefits

• An environment where innovation thrives.
• A culture where every day is an opportunity to make a difference.
• Growth opportunities in a rapidly expanding portfolio.
• A community that values diversity, inclusiveness, and integrity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees