Project Manager - Document & Unified Clinical System

Are you a Project Manager with background in the pharmaceutical industry? Do you have knowledge of clinical study information and enjoy working collaboratively and empower people around you? If yes, AstraZeneca might have the job for you!

We are now looking for a Project Manager - Document & Unified Clinical System that will lead both process and technology improvements to enable end-to-end delivery of clinical studies and/or support projects relating to document and operational trial management for Mergers and Acquisitions. The position can be based either in Gothenburg (Sweden), Warsaw (Poland) or Cambridge (UK).

In this role you will be a member of the Global Clinical Solutions department in the Development Operations organisation. Global Clinical Solutions drives the delivery of Business Process Excellence and Technology for the Development Operations organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external partnerships.

The Development Operations organisation brings together all the skills groups to drive critical operational activities for early and late stage medicines development. We have deep and specialist expertise in study and site & data management, technical systems and processes, and in working with CROs and partner organisations to ensure the best delivery of our clinical trials in countries around the world.

What you'll do:
As Project Manager you will operate in a global setting, driving efficient operation of project teams including overall plans, priorities, budget and risk management. It's your responsibility to build an efficient and high-performing team environment and lead the team towards the right activities at the right time, aligned with coordinated project plan. You will also champion best practice methodology in project management and use business knowledge to drive cross functional and cross-project learning. The role is a is a member of Global Clinical Solutions department in Development Operations and will be a member of the extended leadership team in Document & Unified Clinical System sub-function.

Other responsibilities:

* Provide input into the project strategy & vision through expertise in project management, execution and governance
* Proactively use change management plans and methodology to seek opportunities to drive positive change and remove barriers within and outside the team.
* Contribute to or lead specific aspects of preparing for governance interactions and navigate teams through governance and key processes
* Manage risk including assessment and mitigation planning
* Understand the processes, technology and services the clinical study team relies on and use this knowledge to provide advice and mentorship, removes barriers, provides solutions and sees opportunities for improvement
* Provides guidance and expertise in the planning and delivery of system validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation.

Essential for the role:

* Bachelor's of Science in an appropriate field or equivalent experience.
* Extensive experience in Drug Development within a pharmaceutical or clinical background.
* High level of business process, technology and Clinical Study information knowledge.
* Demonstrated project management skills and proven skills to deliver to time, cost and quality.
* Ability to collaborate, motivate and empower others to accomplish individual, team and organizational objectives.

Desirable for the role:

* Comprehensive knowledge of ICH/GCP.
* Experience in Validation of computerized systems in a regulated environment - preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc. and knowledge of regulatory (GxP, SOX etc.) requirements.
* Great knowledge of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment.

We also see that the successful candidate has experience in working collaboratively with external partners and you have skills in the field of mentoring, problem solving and interpersonal skills. As well as demonstrate great written and verbal communication in English.

Why AstraZeneca?
When we see an opportunity for change, we seize it and make it happen, because any opportunity can be start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey in finding new ways to work, pioneering cutting edge methods and bringing unexpected teams together!

Does this sound like your next challenge? Apply today!

We look forward to you application no later than 20th September, 2020.

For more information about the position, please reach out to Hiring Manager Per Garplid at per.garplid@astrazeneca.com.