EU CTR Part 2 Coordination Associate Director (12 months secondment/fixed term contract)

EU CTR Part 2 Coordination Associate Director

Location: Warsaw, hybrid work

The EU CTR Part 2 Coordination Associate Director (P2C AD) is responsible for coordination of the EU CTR Part 2 submissions together with global regulatory, global study team and local study teams from the participating countries in compliance with the EU CTR requirements, AstraZeneca (AZ) procedures, documents, local and international guidelines and relevant regulations. On top of EU CTR Part 2 Coordination, the P2C AD may be involved in the parallel coordination of IVDR submissions in the allocated studies.

Responsibilities

Coordination and collation of packages

• Attend the global submission planning kick off meeting(s)
• Agree on timeline planning for submission with global team and Site Management and Monitoring (SMM)
• Ensure Local Study Teams (LSTs) are fully aware of submission timelines to allow robust Site Qualification Visits / site selection visits to occur with EU/EEA sites
• Ensure global documents are provided to local teams in time for Part 2 package preparation.
• Collate Part 2 submission Table of Content (ToC) completed by Local Study Associate Directors (LSADs)
• Reach out to the countries to ensure ToC reflects the country submission documents and meets the EU CTR requirements
• Check completeness, not content, of Part 2 submission packages (downloaded documents) with ToC
• Hold EU/EEA LSTs accountable to the delivery of the part 2 package to the agreed timelines
• Coordination of IVDR submissions, if applicable

Provide support to local teams

• EU CTR specific questions
• Questions on document content
• Provide support for Part 2 Requests for Information (RFIs) responses
• Ensure agreement between local teams and global teams on translations as required (CTIS fields, Clinical Study Protocol synopsis, cover letter etc.)

Collation of Part 2 substantial modifications, non-substantial modifications and notifications

• Handling of Part 2 substantial and non-substantial modification requests and notifications from countries – submissions need to be coordinated together with any Part 1 substantial modification

May be involved in process improvement projects and/or leading improvement projects as discussed and agreed upon with their manager

Requirements:

Essential:

• Fully understand the EU CTR regulation, AZ regulatory and clinical trial start up process
• Understands AZ study operation model on global and local level
• Bachelor degree in related discipline, preferably in life science, or equivalent qualification and experience
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
• Basic understanding of drug development process
• Good collaboration and interpersonal skills
• Excellent verbal and written communication skills
• Excellent attention to details
• Excellent understanding of Clinical Study Management and study start-up

Desirable:

• Integrity and high ethical standards
• Good analytical and problem-solving skills
• Basic change management skills
• Good intercultural awareness
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
• Understanding of IVDR regulation and processes

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.