Global Study Leader

Early Clinical Operations team

Hays Specialist Recruitment is now looking to recruit a Global Study Leader to join the Early Clinical Operations team for a 1-year contract assignment at AstraZeneca in Gothenburg.

Due to our promising pipeline and the growth of our Early Clinical Operations team, we have an open position for Global Study Leader.(GSL).
Working on a strong pipeline means so much more than producing innovative, ground-breaking medicines. It allows AstraZeneca people to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

Role:
As a GSL you're responsible for delivery of all aspects of global clinical studies. You will lead and maintain oversight for cross-functional teams comprised of internal and external partners. Ensuing delivery of clinical studies are done effectively and in accordance with clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & standard methodologies and AZ values & behaviours.

Accountabilities:
You will lead, provide guidance and delegate appropriately to a cross-functional study team or lead all aspects of outsourced delivery activities. You will ensure studies are progressed as planned, driving achievement of milestones according to timelines, budget and quality standards. You may work on several studies at any one time. To do this successfully you will be able to lead and facilitate communication across multiple functions, work with multiple external service providers, ensuring delivery and performance to contracted goals and timelines/budget.
You will be accountable for leading the identification of overall study-level risk management activities and ensure mitigation strategies are implemented effectively. You'll be accountable for study budget management (and re-forecasting where required) through the study lifecycle and be able to drive and contribute to all aspects of study operations, including protocol writing, feasibility, vendor selection/start-up, site communication, database locks etc. You'll also work on non-drug project work such as process improvements as discussed and agreed upon with their line manager. May act as subject matter expert for a particular process or system within Early Study Management.

Essential requirements:

* You will be experienced in global clinical project management, comfortable with leading and running cross-functional study teams and leading external providers.
* University degree (or equivalent educational/work experience), preferably in medical or biological sciences or field associated with clinical research
* Extensive knowledge of clinical study management, ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
* Extensive and proven experience in driving operational delivery to timelines, cost and quality and leading cross-functional study teams
* Strong strategic and critical thinking abilities and ability to manage complex situations
* Proven experience leading delivery through internal and external organisations

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.