Global Study Associate Director to AstraZeneca

Exciting opportunity: Global Study Associate Director to AstraZeneca in Gothenburg. Apply Today!

Do you have experience in clinical study management and would like a role where your expertise, as well as your strong leadership skills, will be highly appreciated? Are you team oriented and do you put patients first in your work to make a difference?

We are recruiting for a Global Study Associate Director (GSAD) who will join the Study Management Cardiovascular Renal Metabolic Diseases (CVRM) team (part of BioPharmaceuticals Clinical Operations).

The position will be based in our vibrant R&D sites in Gothenburg. If you´re looking for an exiting role where you can contribute and thrive, then apply today!

Purpose, Offer and Benefits

This position is a one year consulting assignment (end date: 2024-09-30). You will be employed by TNG during the assignment.

At AstraZeneca, we ´re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There´s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Your Responsibilities

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).

What you´ll do:
The Global Study Associate Director (GSAD) is a business-critical role within Study Management, BioPharmaceuticals Clinical Operations, whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team and for providing the team with direction and guidance to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The GSAD leads the study team and/or study oversight team in accordance with the study team operating model, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

The responsibilities will also include:

• 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

Our Gothenburg site is one of AstraZeneca´s three strategic R&D centres. Here, you´ll feel a global atmosphere in a multinational environment. Collaboration comes in all forms - across teams, functions, countries and even companies. With more than 2,400 employees from over than 50 countries, our vibrant Gothenburg site is a truly inspiring place to work.

Our Expectations

To succeed in the role, we believe that you are team oriented and have ability to prioritize appropriately and manage multiple deliverables. We would like you to have demonstrated leadership skills and hope that you enjoy managing change and actively seek and champion more efficient and effective processes. You work independently and have good communication, collaboration and interpersonal skills. Attendance at the office will be required.

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

Desirable Requirements:

• Advanced degree, Masters level education (or higher)
• Project management certification
• Proven project management experience on a global level
• Experience in all phases of a clinical study lifecycle