IQVIA Biotech delivers flexible, tailored, clinical and commercial solutions designed for biotech and biopharma companies. From planning, through trial design and delivery, and commercialization, IQVIA Biotech brings simplified operating procedures, specialized, therapeutically-aligned teams, and advanced data science to provide a more agile way for our customers to reach their drug development and commercialization milestones.
IQVIA Biotech is seeking an experienced Medical Affairs,Medical Data Reviewer whois responsible for the review and analysis of clinical trial medical data. Qualified candidates will have expereince supporting Medical Directors/Medical Monitors in the delivery of quality medical data for sponsors to review.
Qualified Candidates must demonstrate the skill and expereince to perform clinical trial study specific medical data review tasks which includes but not limited to:
- Develop study specific medical data review plans for each study
- Review of Excel listings to ensure accuracy in reporting of adverse events, concomitant medications, vital signs, etc.
- Contribute to EDC design for optimal data capture, and provide specifications for review tools.
- Review of Patient Profiles
- Medical review of coded listings
- Aggregate data review of clinical data using a data analytic platform to identify trends and outliers
- Creating safety trend analysis reports
- Create budgets for medical data review for new study proposals
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- 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
- Execute key medical data review activities for clinical studies
- Conduct data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
- Ensure timely follow-up and resolution of quality and compliance issues
- Ensure data quality focus to sponsors
- Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
- Maintain strong customer relationships
- Participates in a variety of team quality improvement efforts as necessary
- Performs other related duties as assigned or requested by the Director, Medical Data Review, Vice President, Medical or designee
SKILLS AND ABILITIES:
- 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
MINIMUM RECRUITMENT STANDARDS:
- Bachelor's Degree required; clinical, biological, or related field
- Medical Training preferred, e.g. MD, Physician Assistant or Nurse Practitioner degree
- 7-10 years' combined education plus work experience in clinical research related field; e.g.: clinical data sciences at a CRO, pharmaceutical company or other medical research environment
- Biopharmaceutical industry experience or academic experience in clinical research and/or drug development preferred
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.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at firstname.lastname@example.org to arrange for such an accommodation.