Global Study Associate Director - CVRM

Astrazeneca AB; Göteborgs kommun, Mölndals kommun; On-site; SEK 1,000,000 - 1,300,000; Full time

Job summary

AstraZeneca AB in Gothenburg, Sweden, invites applications for a Global Study Associate Director to lead a cross-functional study team, ensure timely, high-quality delivery of clinical studies in CVRM, and act as main liaison between study teams and the Clinical Program Team.

You will develop study level documents, oversee external partners, ensure systems are current, and drive performance against plans and KPIs, including budget re-forecasts throughout the study lifecycle.

Qualifications

• Degree in medical or biological sciences or related field.
• Experience delivering clinical studies.
• Extensive study management experience.
• Solid knowledge of ICH-GCP and regulatory requirements.
• Strong leadership and communication.
• Ability to manage competing priorities.
• Experience with global studies.

Responsibilities

• Lead and guide a cross-functional study team.
• Develop essential study level documents.
• Oversee external service providers.
• Ensure study systems are current.
• Monitor performance against plans, milestones, and KPIs.
• Manage study budget re-forecasting.

Skills

Study management

Cross-functional leadership

Project management

ICH-GCP knowledge

Communication skills

Stakeholder management

Prior pharma experience

Education

University degree

Advanced degree desirable

Job description

Join us as a Global Study Associate Director (GSAD) in our BioPharmaceuticals Clinical Operations team at AstraZeneca's dynamic R&D site in Gothenburg (Sweden). This role is pivotal in the delivery of clinical studies, providing direction and guidance to a cross-functional study team within the Cardiovascular, Renal and Metabolism (CVRM) therapy area. As the main liaison between the study team and the Clinical Program Team (CPT), you will be accountable for the delivery of a study according to agreed timelines, budget, and quality standards.

Accountabilities

As a GSAD, you will lead and provide guidance to a cross-functional study team, ensuring the clinical study progresses as planned. You will be responsible for developing essential study level documents, overseeing external service providers, and ensuring all systems used at a study-level are current and accurate. You will also oversee study level performance against agreed upon plans, milestones, and key performance indicators. Additionally, you will be responsible for study budget re-forecasting and management throughout the study lifecycle.

Essential Skills/Experience

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
• Relevant clinical experience in the pharmaceutical industry, including project management experience
• Extensive study management experience
• Extensive knowledge of ICH-GCP, clinical research regulatory requirements
• Demonstrated solid project management skills
• Strong abilities in team leadership with experience from cross-functional leadership of a clinical study or part of a clinical study
• Excellent communication and interpersonal skills
• Strong strategic and critical thinking abilities
• 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

At AstraZeneca, we are driven by our passion for science and our commitment to making a difference. We fuse data and technology with the latest scientific innovations to achieve breakthroughs that have never been done before. Our inclusive environment allows us to work seamlessly as one, leveraging our diverse global knowledge to create the greatest impact on disease. We are constantly advancing our scientific knowledge to shape the future of healthcare and improve patient access to life-changing medicines.