Global Study Associate Director

Global Study Associate Director

Introduction to role

The Global Study Associate Director (GSAD) is a pivotal role within Study Management, BioPharmaceuticals Clinical Operations, responsible for the delivery of clinical studies. As a GSAD, you will lead a cross-functional study team, providing direction and guidance to ensure successful study delivery. You will act as the main liaison between the study team and the Clinical Program Team (CPT), from study handover through to close-out and archiving. Your accountability to the CPT includes delivering studies according to agreed timelines, budget, and quality standards by fostering effective partnerships and collaboration within the study team and with external partners.

Accountabilities

• Lead, guide, and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure clinical study progression as planned, achieving milestones according to timelines, budget, and quality standards. May hold accountability and/or oversight of several studies.

• Facilitate communication across all functions, including external partners and service providers. Lead and conduct investigator meetings and other study-related meetings.

• Provide input into and hold accountability for the development of essential study-level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant AZ SOPs.

• Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) perform to contracted goals and timelines/budget, document adequate oversight, and raise any issues appropriately. May participate in vendor selection activities.

• Develop and maintain relevant study plans, including required input into study-level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans), ensuring that risk response strategies and issue escalation pathways are clear to the entire study team.

• Ensure information in all systems used at a study level (e.g., ACCORD/ABACUS, PharmaCM) are current and accurate.

• Oversee study-level performance against agreed plans, milestones, and key performance indicators (KPIs, quality and operational) using company tracking systems and project timelines. Communicate any risks to timelines and/or quality to CPT and sDSM/DSM along with proposed mitigations.

• Identify and report quality issues within the study in accordance with relevant AZ SOPs. Collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant partners.

• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times.

• Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency).

• Responsible for study budget re-forecasting following initial budget estimate provided by the CPT. Accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT, including any financial risks and mitigation plans.

• Ensure studies are inspection-ready at all times according to ICH-GCP and AZ SOPs and relevant policies/guidelines. Act as the primary Study Management point-of-contact in the event of an audit or inspection.

Essential Skills/Experience

• Bachelor’s degree in medical, biological sciences, or discipline associated with clinical research

• 5+ years of relevant clinical experience in the pharmaceutical industry, including 2 years’ project management experience, or equivalent combination of education, training, and experience

• Extensive knowledge of ICH-GCP, clinical research regulatory requirements, and demonstrated abilities in clinical study management processes and clinical/drug development

• Demonstrated solid project management skills and knowledge of relevant tools

• Strong, demonstrated abilities/skills in team leadership

• Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and collaborators, along with strong conflict management skills

• Excellent communication and interpersonal skills

• Strong strategic and critical thinking abilities

• Strong organizational and problem-solving skills

• Ability to manage competing priorities

Desirable Skills/Experience

• Advanced degree, Master’s level education or higher

• Project management certification

• Proven project management experience on a global level

• Experience in all phases of a clinical study lifecycle

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 we need 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!

At AstraZeneca, we are committed to making a difference by following the science to explore and innovate. Our dedicated Research & Development team is driven by curiosity and courage, working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We harness digital, data science & AI to fast-forward our research, ensuring that our work born in a lab can make a real difference in patients' lives across the world.

Ready to make an impact? Apply today!

The annual base pay (or hourly rate of compensation) for this position ranges from $136,364 to $204,546. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.