IRT/ eCOA Team Manager (18 months contract)
Processes and Enabling Solutions (PES) drives the delivery of Business Process Excellence and Technology for the Development Operations organization, owning and providing industry leading process, technology and services on behalf of Development Operations and its internal and external Partnerships.
The PES eCOA/IRT Manager (Central Service Team Leader) is a member of Processes & Enabling Solutions department, and is responsible for managing high performing and data driven team, ensuring lifecycle management and business continuity for Development Operations processes, services and tools, performing critical analysis to identify improvements. This role is responsible for leading the eCOA/IRT team that deliver PES service across drug projects and/or other activities that enable delivery of DevOps programs to time, cost and quality across all delivery models and TA’s. The PES Manager leads and oversight Central Service team and is responsible for providing strategy, expert input, guidance, mentoring, training and line management of assigned team members.
- Lead a team that will be responsible for the delivery of eCOA/IRT systems for AstraZeneca Clinical Trials
- Capture and monitor eCOA/IRT delivery metrics, adjusting processes as needed to maximize value, speed of delivery, efficiency and quality.
- Capable of maintaining relationships and driving the success of the eCOA/IRT partnerships in collaboration with Procurement, Alliance Management and other internal and external stakeholders.
- Partnership with R&D Digital team to ensure new digital innovations in eCOA/IRT can be successfully delivered at scale across AZ trial landscape
- Strong understanding of vendor oversight and management framework and can use data to manage issues, CAPAs, and trend analysis appropriately escalating findings through line management and governance.
- Effectively manage and prioritise resource to ensure delivery of the AZ portfolio
- Manage internal/external communication and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources
- Proficient with the interdependencies of key systems used to generate data in clinical trials
- Ability to work with technical, IT and other staff to identify innovation, implement automation and translate new features into centralised operational systems for AstraZeneca
- Understands that patient centricity and that system design and implementation is critical to building the relationship of AZ with patients and site personnel
- Can interpret and implement GCP, GxP requirements to ensure the integrity of data systems and record retention as it relates to eCOA/IRT, in a global environment
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- Meaningful experience in clinical research with demonstratable knowledge of pharmaceutical drug development process and/or software development process
- Well developed project management skills, including management and oversight of vendors, relationships, budgets, timelines and risk
- Knowledge expertise in study management process and electronic data capture systems builds (e.g. IRT, eCOA, EDC)
- Experience in Validation/User Acceptance Testing of computerized systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, and Test scripts
- Knowledge of lean/ agile process and the relevance to system development
Skills and Capabilities
- Excellent negotiation, interpersonal, problem solving and conflict resolution skills
- Ability to work collaboratively, motivate and empower others to accomplish individual, team and organizational objectives
- Excellent verbal and written communication and presentation skills, with the ability to deal with ambiguity and create clarity
- Line and people management, capable of recruiting, retaining and motivating high quality staff
- Extensive project management, organizational, interpersonal, time management, and prioritization skills
- Creative innovator, self starter
Internal and External Contacts - Some examples of contacts/partners are:
- Process and Enabling Solution Leadership Team
- Process and Enabling Solution personell (Systems/Process Owners, other Central Services Leaders, Solution Implementation Leads)
- Procurement and Allianze Management
- Study Management Operations
- R&D Digital Health
- Vendor governanace representatives
- Other as appropriate
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 authorisation and employment eligibility verification requirements.