Job Description

SENIOR MANAGER, RISK MANAGEMENT - EVIDERA

• We are looking to fill this role in Brazil, Philippines or US, as an office-based or remote employee

Position Overview: The candidate is responsible for data integrity and quality of multiple Real World Data Solutions (RWDS) Abstraction Solutions data collection and production tools. Owns the development of standard quality processes such as survey standardization, data mapping/transformations and data loads. Ensures high quality, completeness, and accuracy of the data and compliance with internal, national and international regulations related to Real World Data (RWD) utilization. With corporate Compliance Team, hosts inspections by regulatory authorities such as the MHRA and FDA; that all staff and processes are prepared prior to, co-hosting the inspection itself, subsequent liaison regarding the results and management of any corrective actions required. Develops, implements, and tracks data quality metrics and defines standard best practices for users. Assists with the integration of new surveys or products and participates in the design, development, and implementation of new processes. Analyzes RWDS operation processes and makes recommendations to improve efficiency, provides operational support for enhancements to systems and processes. Critical thinking, accuracy, strong attention to detail with the ability to multi-task when working towards deadlines. The QC candidate is versed in data quality concepts, recognizes data quality problems, suggests solutions, and appreciates the role and importance of data quality in the healthcare/ medical setting and has the ability to extend that knowledge into the wider practice of RWD.
Essential Functions and Responsibilities (other duties may be assigned):

• Organizes and oversees the work and schedules of QC/QA departmental staff.
• Implements policies and procedures that will improve day-to-day and long-term operations.
• Define KPI and metrics to best assess process efficiencies.
• Conducts performance evaluations that are timely and constructive.
• Work closely with the leadership and production teams to develop and implement a strategic operational plan to expand automation of processes while maintaining high quality standards.
• Embeds QC/QA processes in day-to-day production and quality operations and provide guidance, training and leadership to direct reports and other employees.
• Establishes quantitative and qualitative metrics, guidelines, and standards by which RWDS efficiency and effectiveness can be evaluated; identifies opportunities for improvement.
• Implement business strategies, plans, processes and procedures to ensure best practices and maximize operating efficiencies.
• Measures data quality; designs, collects, analyzes, and reports on data quality assurance / production performance metrics such as quality levels, % system errors, near miss metrics, ambiguity, % of returning problems, systematic error among others.
• Responsible for accurate and complete data quality documentation; defines and maintains data standards, definitions, and models (e.g. data dictionary, organizational data model) and DQA documents (e.g., checklists, guidelines, manuals, templates, forms, etc.).
• Measures, tracks and improves data quality from collection to client deliverables.
• Works with the operational team to resolve data quality problems in a timely manner; identifies, assesses, documents, and communicates potential quality issues in the way data is collected, stored, processed, or used.
• Provides guidance to business users to resolve data quality problems using techniques such as root cause analysis and verifying user requirements.
• Recommends design, implements and monitors quality procedures for use in the data production process including data cleansing operations such as removing duplicate records.
• Performs quality review of data entry, loads, transformations, extractions, merges, or other production jobs.
• Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results.
• Perform analysis on data and processes such as change risk analysis, root-cause analysis and develops prevention plans to ensure quality standards are met
• Provides data quality advisory services to the organization; participates in cross-functional teams and development or improvement task forces to ensure data validation and processing is performed as established high quality standards.
• Assists other groups in design of edit checks, test plans, DQ policy decisions, etc. to ensure data quality objectives are met.
• Provides data quality training and presentations to members of the organization.
  

Education, Professional Skills & Experience:

• Bachelor preferable in Business Administration, Data Science, or Statistics and 8+ years of relevant work experience or a Graduate degree and 6+ years of experience.
• Strong understanding of market research and eMR (Electronic Medical Record) data management
• Significant experience with database management and quality control procedures
• Track record of planning and executing regular data audits
• A minimum of 5-8 experience in quality control and testing
• Hands-on experience of managing quality system requirements
• Experience managing and coaching team members
• Expert knowledge of MS Office and Project Management tools
• Work experience with data management in the healthcare/medical desired

Personal Skills & Competencies:

• Strong leadership skills and business acumen
• Ability to effectively mentor and provide direction to staff
• Proven understanding of relationships between data quality control, business process management, data acquisition, and data use.
• Knowledge of appropriate regional regulations and applicable global pharmaceutical industry guidelines
• Knowledge of technical QC/QA processes
• Good verbal and written communication skills
• Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and departmental policies and procedures
• Detail oriented with ability to deal with multiple and changing priorities

About Evidera: Evidera is a business within in Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.
Perks: We offer a competitive salary and benefits package, with clear opportunities for growth and career progression. You will have the opportunity to work on multiple projects with some of the industry’s leading researchers. Our offices boast a fun and collaborative working environment, frequent social events and a robust support system. We are committed to providing training and professional development, with ample opportunity to advance, for all our staff.
Evidera’s Core Competencies:

• Customer Focus
• Initiative
• Teamwork
• Problem Solving/Judgment
• Accountability

If you resonate with our core competencies and want to contribute to research and consulting services driven by world-class science and thought leadership, then please submit your application – we’d love to hear from you.
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

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