Global Study Associate Director

Do you have experience in clinical study management and would 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 AstraZeneca might be the right place for you to contribute and thrive.
We are looking for a Global Study Associate Director (GSAD) who will join the 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.
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).

Hays is looking for a Global Study Associate Director for a 12-month consultant assignment at our client AstraZeneca, Gothenburg

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

The GSAD leads the study team &/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 & best practices & in line with AZ values.

Responsibilities include:
* Lead, provide guidance & 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 & quality standards. May hold accountability &/or oversight of several studies.
* Lead & facilitate communication across all functions, incl. external partners & service providers. Lead & conduct investigator meetings & other study related meetings.
* Provide input into & hold accountability for the development of essential study level documents in accordance with relevant AZ SOPs.
* Ensure all external service providers are performing to contracted goals & timelines/budget & that adequate oversight is documented & issues are escalated appropriately. May participate in vendor selection activities.
* Develop & maintain relevant study plans incl. required input into study level quality & risk management planning, ensuring that the risk response strategies & issue escalation pathways are clear to the study team
* Accountable for ensuring that information in all systems utilized are current & accurate.
* Oversee study level performance against agreed upon plans, milestones & KPIs by using company tracking systems & project timelines. Communicate any risks to timelines a&/or quality with proposed mitigations
* Identify & report quality issues occurred within the study in accordance with relevant AZ SOP. Collaborate with all functions as necessary to overcome barriers & achieve milestones. Proactively communicate findings & CAPAs to relevant stakeholders
* Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, incl. ensuring the TMF plan & Expected Document List are in place & that QC activities are performed on an ongoing basis to ensure TMF completeness
* Ensure timely compliance with company-wide governance controls
* The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT & accountable for study budget management through the study lifecycle & for providing budget progress reports to the CPT incl. financial risks & mitigation plans
* Ensure studies are inspection-ready at all times, according to ICH-GCP & AZ SOP & relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection

To succeed in the role, you:

* are team oriented
* have ability to prioritize appropriately & manage multiple deliverables
* have demonstrated leadership skills
* enjoy managing change
* actively seek and champion more efficient & effective processes
* work independently
* have good communication, collaboration & interpersonal skills

Attendance at the office will be required.

Essential Requirements:
* University degree (or equivalent), preferably in medical/biological sciences or discipline associated with clinical research
* 5 yrs relevant clinical experience in the pharma industry, incl. 2 yrs project management experience, or equiv. education, training & experience
* Extensive knowledge of ICH-GCP, clinical research regulatory requirements & demonstrated abilities in clinical study mgmt processes & clinical/drug development
* Demonstrated solid project mgmt skills & knowledge of relevant tools
* Strong, demonstrated team leadership
* Strong abilities in establishing & maintaining effective working relationships with internal & external stakeholders, & strong conflict management skills
* Excellent communication & interpersonal skills
* Strong strategic & critical thinking
* Strong organizational & problem-solving skills
* Ability to manage competing priorities

Desirable:
* Advanced degree, M.Sc. or higher
* Project mgmt certification
* Proven project mgmt experience on global level
* Experience in full clinical study lifecycle



If you're interested in this role, apply today!