Solution Implementation Lead (Processes and Enabling Solutions Manager)
The Solution Implementation Leader (former Enablement Lead) 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 Process and Enabling Solutions (PES) offer. SILs are accountable for the setup, implementation and operations of the PES suite of clinical operations systems, such as IRT and eCOA. SILs have a high degree of expertise in project management framework, e2e study management processes and systems, and vendor partnering. By partnering with Global Study Mangement Teams, the Solution Implementation Leader identifies new opportunities within scope of PES in support of continuous improvement and rigorous execution of clinical trials.
- IRT & eCOA e2e systems initiation and oversight over requirements gathering, required integrations, user acceptance testing, deployment, maintenance, and closeout. Project manage delivery to meet time, quality and costs.
- Cooperate with CPT, Global Study Team, Digital Team, Procurement on establishing and implementing a proper technology strategy for a study, meeting study needs and minimazing data integrity risks
- Serves a first line of contact on a study for gSMTs to PES service catalogue (IRT, eCOA, CTMS, eTMF, Event Adjudication etc), so as to enable fast and focused decision-making or issue resolution/ escalation
- Lead and/or contribute to activities supporting Audits & Inspection Readiness, audits, regulatory inspections
- Review protocol and provide required input from system perspective, translate protocol and business needs into system requirement specification
- Provide guidance in implementing new technologies related to risk impact determination and validation strategy
- Provide ongoing feedback to PES 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
- TA/ compound/ indication aligned to establish and execute common standards, functionalities and ways of working unique for specific TA/ compound/ indication
- 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 proper knowledge of clinical processes and systems
- Well developed project management skills, including managing vendors, budgets, timelines and risks
- 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
- Demonstrates good knowledge of GCP, AZ Procedural documents, as they pertain to study delivery systems and processes
- Good understanding of E2E patient and operational data flow in clinical systems, dependencies between systems, reconcilliation principles
- Technical skills and knowledge expertise in study management process and systems areas (e.g. IRT, ePRO, MI/ECG/Spirometry, CTMS, eTMF, EDC)
- Understand principles of Opertaional Due Diligence and vendor validation aspects
- Ability to work globally including international travel
Skills and Capabilities:
- Excellent negotiation, interpersonal, problem solving and conflict resolution skills
- Ability to works 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, representing the needs of multiple customers in decision making process
- Comprehensive understanding of dynamics affecting the pharmaceutical industry and needs for transformation
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.