Global Study Leader

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.

 

ABOUT ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

 

We believe in growing together!