IQVIA

Clinical Data Manager

IQVIA • $68K — $171K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Minimum 5 years of data management experience required.
  • Bachelor's degree or relevant certification in allied health preferred.
  • Experience with Electronic Data Capture (EDC) systems required.
  • Familiarity with Oracle Inform™ EDC system preferred.
  • Experience in oncology or inflammatory therapeutic areas preferred.
  • Project management experience within Data Management preferred.
  • Background in Clinical Research Organization (CRO) or CRO management preferred.

Responsibilities

  • Communicate key clinical data management metrics and recommend actions.
  • Review and develop clinical trial documents including Case Report Forms and Data Management Plans.
  • Participate in User Acceptance Testing (UAT) as required.
  • Engage in Quality Control (QC) activities as necessary.
  • Collaborate with Clinical Database Programmers on data management specifications.
  • Provide training for sites or third-party vendors on CDM topics.
  • Offer data review training and guidance to Sr. Clinical Data Coordinators.
  • Perform data review and resolve discrepancies as needed.
  • Archive trial documentation upon completion.
  • Ensure compliance with Good Clinical Practice and regulations.

Benefits

  • Health and welfare benefits available.
  • Potential for incentive plans and bonuses offered.
Full Job Description
Job Summary

The Clinical Data Manager performs activities pertaining to the conduct of Phase I-III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality.

Summary of the Essential Functions of the Job
  • Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team.
  • Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
  • Participate in User Acceptance Testing (UAT), as needed.
  • Participate in Quality Control (QC), as needed.
  • Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
  • Assist with site and/or third party vendor training on CDM-related topics.
  • Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
  • Perform data review and discrepancy resolution, as needed.
  • Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
  • Ensure adherence to Good Clinical Practice and all applicable local and international regulations.


Minimum Requirements
  • Minimum of 5 years of data management experience is required.
  • Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
  • Experience with Electronic Data Capture (EDC) system(s) is required.
  • Experience with Oracle Inc.'s Inform™ EDC system is preferred.
  • Oncology and/or inflammatory therapeutic area experience is preferred.
  • Project management experience (within Data Management) is preferred.
  • Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.


The potential base pay range for this role, when annualized, is $68,500.00 - $171,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ
IQV
* Ladders Estimates

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