IQVIA Senior Clinical Data Specialist (Home/Office-Based) - Novella Clinical in Marlborough, Massachusetts

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

POSITION TITLE: Senior Clinical Data Specialist

REPORTS TO: Associate Manager/Manager, Data Management or Designee

BASIC FUNCTIONS:

Senior Clinical Data Specialist position is to ensure a quality database per industry standards and client specifications, while being a leader within the department as a subject matter expert for a system and/or process.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Clinical Data and Query Review:

  • Create listings using ad hoc query tools

  • Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (Tumor Response, AE/CM compares), and Reconciliation (Laboratory, SAE, ECG, and other vendors )

  • Assist other data reviews for Biostatistics, Medical Review, Client, and other ad hoc reports

  • Oversees System Development:

  • Create or draft CRF design, edit check specification and DM listings

  • Consolidate comments from internal/sponsor for discussion and approval

  • Ensure all non-DM activities related to database development are completed in a timely manner

  • Subject matter expert for DM product or process:

  • Create and Update SOPs/WP related to the product or process

  • Provide training for DM and other staff members on process and/or product implementation

  • Consult with DM leads or other team members on implementation and best practices

  • Participate in user group meetings as the Novella representative

  • Study Management:

  • May serve as Lead DM or Back-up DM lead

  • Produce and Review Metric reports for internal/external project team

  • Provide feedback to improve the system or reports

  • Discuss roadblocks for getting processes done in a timely manner

  • Review project budgets and staffing projections for data management activities

  • Provide the DM lead or PM with status updates on tasks that are assigned

  • Assist with the on the job training of DM staff for the study

KNOWLEDGE, SKILLS AND ABILITIES:

  • Team player with ability to work well with technical and clinical team members

  • Ability to collaborate with entire clinical team (CRAs, Safety, Bios, etc.)

  • Excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (RECIST, CDISC/CDASH, Labs, Adjudication, etc.)

  • Ability to adhere to and create detailed DM study instructions and documents (CRF guidelines, Trial Design Document, edit check specifications, etc.)

  • Ability to perform research for data collection and protocol specific topics

  • Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)

  • Organized and thorough with attention to details

  • Effective Interpersonal skills and excellent communications skills, verbal, written and listening

  • Ability to learn new things, teach others, and accept constructive criticism

  • Effective logical thinking ability in regards to Problem-solving skills

  • Proficiency in computer applications (Windows, Excel, Word, Outlook etc.)

  • Ability to work independently

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)

  • Travel, occasional as required for bid defenses, Investigator Meetings, or other meetings as requested, not anticipated to exceed 40hr per year.

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and

  • 3 years of experience in pharmaceutical industry and/or contract research organization, with 2 years in data management

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.