DirecciónJob Description
CORE Accountabilities and Responsibilities :
Overarching Responsibilities :
It is business critical that our company receives consistent, accurate, high-quality data from clinical trials conducted worldwide.
REAIM ( Risk Evaluation & Adaptive Integrated Monitoring ) organization brings our company into a state of the art model and new ways of working to manage risk and central analytics and ensure exquisite oversight of our clinical trials.
It is also business critical the integrity of data is maintained and preserved. Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the integration between our source systems (primarily Data Management Workbench (DMW)), our company IT Data hub and Supplier’s environment.
Among key responsibilities are :
TECHNICAL ENABLEMENT :
Provides critical support in establishing technical and cross functional business needs between our company's Business (e.
g. Global Data Management & Standards (GDMS), Biostatistics & Research Decision Sciences (BARDS), Medical Monitoring, Site Monitoring), our company's IT and Supplier that will drive build out, testing, implementation and maintenance of business critical Key Risk Indicators (KRI)s.
Responsible of the coordination between our company's IT and Supplier, across the studies assigned, for the integration of applicable systems data (e.
g. our company's IT data hub - InForm, DMW, Clinical Data Repository (CDR), Site Management Authoring and Reporting Tool (SMART) and others if needed- and the Supplier system) in order to support generation of study KRIs and Quality Tolerance Limits (QTL)s out of Supplier system.
Supports the implementation of system enhancements and bug fixes or Data Integration enhancements per agreed timelines
Establishes and provides oversight of Change Control Board (CCB) to coordinate and prioritize between our company's Business, Research Division IT Systems Owners and Supplier any system, bug fixes and KRI enhancement projects.
REAIM STRATEGY :
Contributes to the standardization of REAIM procedures, tools and templates to ensure consistency and seamless progression through the study lifecycle.
Provides recommendations of future systems, Data Integration and KRI enhancements, and supports applicable process development and maintenance
COLLABORATION :
Proactively collaborates with applicable process owners in GCD and GCTO like our company's IT, Medical Monitors, Clinical Scientists, Clinical Quality Operations Managers (CQOMs), GDMS, BARDS Statisticians and rest of members of the Clinical Trial Teams (including Country roles) to ensure that systems and any outlined processes are compliant and Inspection ready.
INSPECTIONS :
Responsible for maintaining ongoing inspection readiness for system integration of risk management and central analytics processes as well as preparing for, management and follow up of regulatory inspections
Educational Requirements :
Required :
Bachelor’s degree in science or equivalent healthcare experience in relevant health care area, preferably in Pharmacy, Nursing, Biological Sciences, Data Sciences and Statistics or health care related discipline
Experience Requirements :
Required :
Relevant 6 year's experience in system, data flow and integration
Superior oral and written communication skills in an international environment.
Excellent project management and organizational skills :
Strong leadership skills that allow the position to work and lead effectively in a virtual, culturally diverse environment, including conflict resolution expertise and discretion.
Preferred :
Cross-functional experience in clinical research (e.g., monitoring, data management, clinical quality assurance, study management)
Experience with risk management tools and processes within the clinical quality framework.
Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
Knowledge and application in Lean Six Sigma and Agile Methodologies.
Experience and skills in producing and visualizing metrics.
Ability to think strategically and objectively and with creativity and innovation.
Profound understanding of data and metrics, technical skills.
CORE Competency Expectations :
Business and financial acumen
Strategic thinking
Ability to think cross-functionally and working across boundaries internationally
Ability to identify problems, conflicts, and opportunities early and lead, analyze mitigation plans and drive conflict resolution is critical.
Profound understanding of data and metrics, technical skills
Superior oral and written communication skills in an international environment.
Expert knowledge of International Conference on Harmonization Good Clinical Practice (ICHGCP)
E6 risk-based quality management (RBQM) methodology and worldwide Regulatory
Health Authority requirements and Good Documentation Practices.
Ability to lead cross-functional teams of business professionals within our Research Division
Able to act urgently for worldwide health authority inspection matters.
Ability to analyze, interpret and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
Experience with risk management tools and processes within the clinical quality framework.
Behavioral Competency Expectations :
High emotional intelligence
Strong leadership and negotiation skills
Positive proven success in people management
Demonstrated ability to build relationships with senior business executives
Influencing skills
Excellent interpersonal and communication skills, conflict management
Relationship management and networking : strong integration into country and HQ TA network and ability to build productive relationships with all parties
Effective time management
Effective communication with external customers
Possess Data Literacy skill sets : i.e. have the ability to read, understand, create, and communicate data as information by prioritizing cultural change within our company's Business and fostering a data-driven mindset and orientation, i.
e. use of KRIs and QTLs in adaptive risk assessment, evaluation and decision making
EligibleforERP
