Assoc Director, Medical Data Review (w,m,d)

POSITION TITLE:                       Associate Director, Medical Data Review

REPORTS TO:                                Director, Medical Data Review or Designee          

BASIC FUNCTIONS:

The medical department consists of the Vice President, Medical; Senior Director, Medical Operations; Senior Directors, Medical; Senior Medical Directors and Medical Directors; Medical Data Review Directors; Clinical Scientists; Medical Safety and Data Reviewers; Medical Operation Bidders; and Medical Monitor Operations Specialists. 

The IQVIA Biotech Associate Director, Medical Data Review provides medical data review expertise for clinical research studies, leading a team of medical data review staff to conduct analysis of medical data in order to ensure data quality. The goal of the Associate Director, Medical Data Review is to use expert skills to utilize quality medical data review products to guide and perform medical data review services that meet sponsors’ needs.

The IQVIA Biotech Associate Director, Medical Data Review will lead a team of medical data review staff in support of IQVIA Biotech Medical Monitors in the delivery of medical data review to sponsors. The IQVIA Biotech Associate Director, Medical Data Review will be responsible leading the design and execution of key medical data review activities for clinical studies. These will include the development of study specific medical data review plans for studies as requested by the Director, Medical Data Review or designee, or Medical Director, and include recommendations for and creation of specific tools and data review platforms for each study. The Associate Director, Medical Data Review will lead discussions on medical data review and analytics project requirements and strategic planning, providing  support at client meetings including bid defenses, Client Alignment Meetings, and Kick Off Meetings, and provide guidance and recommendations regarding the review of medical data obtained during the course of the study.    

The Associate Director, Medical Data Review can train team members on the following, as well as perform the tasks of creating a Medical Data Review Plan, defining data capture requirements; identification  of anomalies in patient-reported data; identification of  potential safety signals and creation of safety trend analysis reports and performance of other study specific medical data review tasks.

The Associate Director, Medical Data Review may also train staff and/or perform the following: defining data capture requirements; identification of anomalies in patient-reported data; and review and identification of inaccuracies and while ensuring that all necessary supporting information is provided. They may also perform other unspecified tasks in support of the IQVIA Biotech Medical Department at the request of the Director, Medical Data Review or IQVIA Biotech Vice President, Medical.        

Job Profile Summary:

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manage and support a team of Medical Data Reviewers
• Provide expert review and guidance for production of Medical Data Review deliverables
• Define and prioritize resource requirements and manage resource assignments across projects
• Monitor and manage utilization and productivity of the department team members
• Monitor and alert Director, MDR of need for additional staff members based on current and anticipated work load
• Determine departmental training needs in conjunction with the Director, MDR and implement training and professional development processes for department members
• Identify sponsor expectations for medical data review at the proposal or study award stage
• Support the creation of a budget for medical data review for incorporation into the overall study budget
• Develop study specific Medical Data Review Plans for each study as requested by the Director, Medical Data Review, Operational Bidder, Medical or Medical Director
• Provide medical data review guidance based on medical, clinical and data expertise
• Design and execute key medical data review activities for clinical studies
• Recommend study specific tools and data review platforms to external and internal customers at the request of the Director, Medical Data Review and/or the Medical Director
• Define data capture requirements in line with protocol and reporting needs
• Supervise and/or conduct data trend analysis in support of data quality and integrity, including protocol compliance and targeted review of patient data
• Attend Kick-Off meetings, Client Alignment Meetings, team meetings, and client meetings, as needed or requested
• Ensure timely follow-up and resolution of quality and compliance issues
• Ensure data quality focus to sponsors
• Represent medical data scientific guidance at multi-disciplinary team meetings and external meetings
• Continuously look for opportunities to improve efficiency of tasks and quality of deliverables, followed by implementation
• Drive the delivery of end-to-end study data quality and integrity
• Maintain strong customer relationships

SPECIAL PROJECT:

• May obtain literature search to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
• Participation in a variety of team quality improvement efforts as necessary
• Perform other related duties as assigned or requested by the Director, Medical Data Review or designee, Vice President, Medical

SKILLS, AND ABILITIES:

• Ability to serve as a people manager
• Ability to work in partnership with a multidisciplinary group of colleagues
• Outstanding ability to work independently with minimal supervision

• Ability to work effectively within a team and matrix environment, including coworkers, managers and clients

• Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
• Excellent oral and written communications skills and interpersonal skills
• Outstanding customer focus skills for internal and external team members

• Attention to detail
• Strong analytical skills and understanding of medical/clinical data
• Ability to proactively identify issues of significance
• Working knowledge of medical terminology, pharmacology, anatomy, and physiology
• Medical and operational focus towards metrics and status information, and aptitude to take appropriate actions for appropriate resolution
• Excellent organizational and problem-solving skills
• Ability to work on multiple projects and manage competing priorities
• Ability to plan and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time-based metrics
• Excellent coaching skills

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's Degree required; clinical, biological, or related field
• Medical Training preferred, e.g. MD, Physician Assistant or Nurse Practitioner degree
• 10 years’ combined education plus work experience in clinical research related field; e.g.: clinical data sciences/medical data review at a CRO, pharmaceutical company or other medical research environment including people management experience
• Minimum 1-3 years of biopharmaceutical industry experience or academic experience in clinical research and/or drug development
• Advanced knowledge of Medical Data Review processes and systems
• Solid understanding of clinical drug development process

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Ability to travel domestically and internationally as required
• Very limited physical effort required to perform normal job duties

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.