Global Data Management Leader

Do you have Data Management experience from the Pharma, BioTech or CRO industry? Do you also have great knowledge of GCP, regulatory requirements and Good Clinical Data Management Practices and would like to apply this to support the delivery of life-changing medicines?

At AstraZeneca in Gothenburg we are currently looking for a driven and engaged Global Data Management Leader. You will be a part of the Clinical Data and Insights team - bringing together Data Management, Programming, Standards, Automation, TRISARC, Centralized Monitoring and Business Solutions and Operations. Responsible for driving critical strategic and operational activities for early and late stage medicines development across BioPharmaceuticals R&D and Oncology.

The Clinical Data and Insights team are operating within the Development Operations organisation with ~2,300 people that have deep, specialist expertise in study and site management, data management and programming. Delivering accessible clinical trials and maximize the potential of data to drive clinical trial innovation.

What you will do:
As GDML you will provide CDM (Clinical Data Management) subject matter expertise to the study team(s) and is responsible for overseeing and managing all CDM activities for the study. You serve as a core team member of the Global Study Team(s) and is accountable for all CDM-related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP).

The GDML is accountable for the overall quality and integrity of the clinical database, and they work collaboratively to ensure that AstraZeneca's Clinical Data is collected, managed, and reported clearly, accurately, and securely based on the study's protocol and to the highest scientific industry standards. You are accountable for development and oversight of CDM processes, standards and functional leadership - as well as being accountable for the management of vendor performance and also for providing input into CDM related activities associated with regulatory inspections/audits for assigned studies.

Typical Accountabilities:

* Manages and resolves issues related to CDM deliverables by developing solutions to complex problems to ensure consistency across organization.
* Assesses AstraZeneca CDM needs and areas of improvement and recommends changes to the operating model
* Reviews, assesses and manages CDM delivery against KPIs and overall DM performance
* Manages all CDM timelines and CDM Deliverables for assigned studies
* Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities
* Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house)

Essential in the role:

* University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree
* Strong Data Management experience in the Biotech/Pharma/CRO industry
* Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
* Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
* Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
* Demonstrate understanding and experience in query management process and reconciliation activities

The successful candidate also has strong communication and interpersonal skills, with the ability to work independently under direction and supervision in a global team environment. High attention to detail and accuracy is significant for the role - as well as excellent written and verbal communication skills. Of high important is also great leadership capabilities and knowledge.

Desirable in the role:

* Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
* Demonstrated knowledge of clinical and pharmaceutical drug development process
* State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
* Demonstrated understanding of clinical data system design / development / validation and system interoperability.
* Demonstrated ability to work effectively with external partners.

Why AstraZeneca in Gothenburg?
Our Gothenburg site is one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to develop a working environment that furthers collaboration, openness and innovation. Therefore, we have built space for meetings and socializing, where spontaneous meetings can give birth to new innovations.

If you this sound like the job and place for you - apply today! Welcome with your application no later than 11th December, 2020.