ASSOCIATE SYSTEM & DATA INTEGRATION LEAD (HYBRID)

Job 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.
.
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.
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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.
., 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.
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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.
.
use of KRIs and QTLs in adaptive risk assessment, evaluation and decision making #EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado Click here to request this role's pay range.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
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