Associate Director, Global Clinical Solutions, Solutions Implementation Lea

at  AstraZeneca

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Global Clinical Solution (GCS) drives the delivery of Business Technology Excellence for R&D by providing industry leading technology and services in collaboration with internal and external Partners.
The Solutions Implementation Lead (SIL) serves as the primary point of contact and business partner for Global Study Management Teams (gSMTs) and other functions for all clinical systems and services that GCS offer. SILs are accountable for the setup, implementation, and maintenance of the GCS suite of clinical operations systems, such as Interactive Response Technology (IRT) and Electronic Clinical Outcome Assessment (eCOA). SILs have a high degree of expertise in project management framework, End to End (E2E) study management processes and systems, and vendor partnering. In collaboration with Global Study Management Teams, the Solutions Implementation Lead identifies new opportunities within scope of GCS in support of continuous improvement and rigorous execution of clinical trials.

REQUIREMENTS:

• University degree (or equivalent), preferably in medical/ biological sciences or discipline associated with clinical research or computer science. 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.
• Ability to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development in terms of processes and systems, on multiple studies.
• Good understanding of E2E patient and operational data flow in clinical systems, dependencies between systems, reconciliation principles.
• Technical skills and knowledge expertise in study management process and systems areas (e.g. IRT, eCOA, CTMS, eTMF, Electronic Data Capture).
• Understand principles of Operational Due Diligence, vendor selection and validation.
• Ability to work globally including international travel.

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
• Proven ability to prioritize and manage multiple tasks with conflicting deadlines
• Proactively identifies risks and issues and possible solutions
• Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities
• Change management skills and championship of continuous improvement
• Conceptual, Analytical and Strategic thinking; concern for standards and willingness to learn from others
• Passion for customers and patient well-being, representing the needs of multiple customers in decision making process
• Comprehensive understanding of dynamics affecting the pharmaceutical industry and needs for transformation

• IRT & Digital Patient Solutions (DPS – eCOA plus sensors/devices) E2E process initiation and oversight over system requirements gathering and integrations, user acceptance testing, deployment, maintenance, and closeout. Project manage delivery to meet time, quality, and costs.
• Cooperate with GCS Central Services – mainly IRT and eCOA Managers who are responsible for IRT and DPS set up, maintenance and close out. Knowledge sharing within the therapeutic area and/or assigned compound developing and maintaining standards fitting customer and patients’ needs.
• Cooperate with Clinical Project Team (CPT), Global Study Management Team, Digital Health Team, Patient Centred Science, Procurement, Alliance Management, Quality and IT Teams on establishing and implementing appropriate technology strategy for a given programme/study, meeting needs of required data collection and minimizing data integrity risks.
• Serves as a first line of contact for gSMTs to GCS service catalogue (IRT, DPS (eCOA plus sensors/devices), Clinical Trial Management System (CTMS), Electronic Trial master File (eTMF), Event Adjudication etc.) to enable fast and focused decision-making or issue resolution/escalation.
• Lead and/or contribute to activities supporting Audits & Inspection Readiness and participate in audits/regulatory inspections when required.
• Report and drive completion of Quality Issues and Corrective and Preventive Actions (CAPAs) in space of IRT and DPS.
• Review protocol and provide therapeutic area system specific expertise.
• Provide operational and strategic guidance to gSMTs in implementing new technologies related to risk impact determination and validation strategy.
• Provide ongoing feedback to GCS functions related to utilization of systems and processes to continuously improve our service delivery based on customer feedback. Participates in process/system improvement initiatives.
• Develop and manage relationships with external technology and service providers.
• Assigned to multiple studies with focus on study set up, with proactive consultancy for studies in maintenance in terms of system changes and issues resolution/escalation.