Job Opportunity: Clinical Data Management at IQVIA
Position Name:
Clinical Data Management
Organization:
IQVIA
Location:
Hyderabad, India
Experience:
6+ Years
Qualifications:
- B.Pharm / M.Pharm
- Pharm.D
- B.Sc / M.Sc in Life Sciences or related fields
Salary:
Not Disclosed
About IQVIA
IQVIA is a global leader in healthcare technology and analytics, specializing in the integration of data and human science to provide solutions for clinical research and drug development. IQVIA is known for offering innovative solutions that enhance the quality and effectiveness of clinical trials, drug development, and healthcare delivery across the world. With a robust commitment to innovation, IQVIA is shaping the future of healthcare by providing key insights and technology solutions.
Job Overview
As a Clinical Data Management professional at IQVIA, you will manage all aspects of clinical data management, from protocol review to database lock. This role involves ensuring timely and accurate data collection, maintaining data quality, and meeting regulatory standards for clinical trials. You will also play a crucial role in overseeing vendors and ensuring adherence to FDA, ICH, and global regulatory guidelines.
Key Responsibilities
- Protocol Review & CRF Design:
Collaborate with clinical teams to review study protocols and design Case Report Forms (CRFs) in line with clinical data requirements. - EDC System Management:
Handle EDC systems such as Medidata RAVE and Oracle Clinical. Perform query trend analysis, protocol deviation reviews, and manage study timelines. - Data Review/Management Plans:
Develop and implement clinical data review and management plans. Author and update key study documents like Data Quality Management Plans, Data Validation Plans, and eCRF Completion Guidelines. - Vendor Management:
Oversee Clinical Data Management vendors to ensure compliance with protocols and data delivery timelines. Conduct data review and ensure the accuracy of vendor outputs. - Cross-Functional Team Collaboration:
Lead Data Quality Review meetings and represent Data Management on cross-functional and submission teams. - Regulatory & Submission Knowledge:
Maintain knowledge of regulatory requirements, including NDAs, BLAs, and MAAs, to ensure that clinical data management aligns with global submission standards. - Mentoring & Oversight:
Provide training, coaching, and mentoring to junior Clinical Data Management staff to support their development and the success of the team.
Qualifications
Must Have:
- Bachelor’s Degree in Life Sciences, Pharmacy, or related fields.
- 6+ years of experience in Clinical Data Management.
- Proficiency with EDC systems such as Medidata RAVE.
- Strong project management, communication, and analytical skills.
- Experience with clinical operations, query trend analysis, and collaboration with cross-functional teams.
Nice to Have:
- CCDM Certification.
- Knowledge of ICH-GCP, 21CFR Part 11, and data privacy regulations.
- Strong understanding of GCPs and data handling protocols in clinical research.
Job Responsibilities Breakdown
| Responsibility | Details |
|---|---|
| CRF Design & Protocol Review | Review clinical study protocols and design CRFs in line with study data requirements. |
| Vendor Management | Oversee CDM vendors, ensuring timely and accurate data management deliverables. |
| EDC Systems | Manage Medidata RAVE, Oracle Clinical, perform query analysis, and ensure study timelines are met. |
| Document Creation & Review | Author and revise key study-related documents such as Data Quality Management Plans. |
| Team Leadership | Lead Data Quality Review meetings and mentor junior staff. |
| Regulatory Compliance | Ensure adherence to FDA, ICH guidelines, and submission protocols for clinical studies. |
Application Process
How to Apply:
Interested candidates can submit their application via the IQVIA careers portal or email the HR team with their updated resume and supporting documents.
Important Notes
- No Recruitment Fees:
IQVIA does not charge any recruitment fees. Be cautious of fraudulent activities related to job offers.
About IQVIA
IQVIA’s mission is to accelerate innovation in the healthcare sector by harnessing the power of data and advanced analytics. Their solutions support the end-to-end lifecycle of clinical trials and drug development, making a significant impact on the global healthcare landscape. Learn more about IQVIA on their Wikipedia page.
Be a part of a global leader in healthcare and technology. Apply Now!