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Associate Director, Global Clinical Solutions

hace 2 semanas

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**Associate Director, Global Clinical Solutions (Solution Implementation Lead)**:
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, GCS Study & Data Solutions 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 operations of the GCS suite of clinical operations systems, such as IRT (Interactive Response Technology = IWRS, IVRS, IXRS, RTSM) and DPS (Digital Patient Solutions). 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 Management Teams, the Solutions Implementation Leader identifies new opportunities within scope of GCS in support of continuous improvement and rigorous execution of clinical trials.

**Responsibilities**:

- IRT & Digital Patient Solutions (DPS - eCOA plus sensors/devices) 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 GCS Central Service - mainly IRT Leads and DPS Specialists that works hands on IRT and DPS set up, maintenance and close out to share TA/compound expertise and well-established solutions fitting customer and patients’ needs
- Cooperate with CPT, Global Study Team, Digital Team, Patient Centred Science, Procurement, Alliance Management, Quality and IT on establishing and implementing appropriate technology strategy for a given programme/ study, meeting needs and minimizing data integrity risks
- Serves a first line of contact on a study for gSMTs to GCS service catalogue (IRT, DPS (eCOA plus sensors/devices), 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
- Report and drive completion of Quality Issues and CAPAs in space of IRT and DPS
- Review protocol and provide therapeutic area system specific expertise, translating protocol and business needs into patient centric system requirement specification
- Provide operational and strategic guidance 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
- TA/ compound/ indication aligned to establish and execute common standards, functionalities and ways of working unique for specific TA/ compound/ indication

**Profile**
- 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
- 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, DPS/eCOA, CTMS, eTMF, EDC)
- Understand principles of Operational Due Diligence and vendor 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