Global Study Associate Director at AstraZeneca

Do you have experience in clinical study management? We are seeking a Global Study Associate Director to join AstraZeneca.

Would you like a role where your expertise, as well as your leadership skills, will be highly appreciated? Are you team oriented and do you, as we do, put patients first in your work to make a difference? Then the role as a Global Study Associate Director at AstraZeneca in Gothenburg might be the right one you!

Purpose, Offer and Benefits

This is a consulting assignment set to start in October and is expected to continue until September 30, 2024. The selection process is ongoing, and please kindly note that there are only 10 days to apply for this role from the day the job posting is published.

You will join our Study Management Cardiovascular Renal Metabolic Diseases (CVRM) team – which forms part of BioPharmaceuticals Clinical Operations . The position will be based in our vibrant R&D sites in Gothenburg, Sweden.

At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Your Responsibilities

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
• Lead and 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.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated 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, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
• Accountable for ensuring that information in all systems utilized at a study-level are current and accurate.
• Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines and communicate any risks to timelines and/or quality with proposed mitigations
• Identify and report quality issues that have occurred within the study in accordance with relevant AZ SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders
• Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including 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)
• The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and 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 (as part of the ongoing study change control process)
• Ensure studies are inspection-ready at all times, according to ICH-GCP and AZ SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection.

The Bigger Picture

Study Management CVRM, are accountable for delivering high quality, cost efficient clinical studies (phase 1 to phase 3) that support drug development within Cardiovascular Renal Metabolism (CVRM).

The Global Study Associate Director (GSAD) is a crucial role in BioPharmaceuticals Clinical Operations responsible for overseeing clinical study delivery. They lead a cross-functional team, serve as a liaison to the Clinical Program Team, and ensure study success within agreed timelines, budget, and quality standards. The GSAD follows regulatory guidelines, AstraZeneca SOPs, policies, and values in leading the study team.

Our Expectations

Essential Requirements:

• University degree (or equivalent), preferably in medical or 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 stakeholders, 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