Job Posting: Senior Clinical Data Associate – Ahmedabad
Summary: Are you an experienced Clinical Data Associate looking to elevate your career? Advanced Clinical, a leading global clinical development and strategic resourcing organization, is seeking a highly motivated and detail-oriented Senior Clinical Data Associate to join our growing team in Ahmedabad. This on-site role offers a challenging and rewarding opportunity to contribute to impactful clinical trials, ensuring data integrity and compliance with industry standards. If you have a strong understanding of clinical data management principles, a meticulous approach to data review, and a passion for improving patient outcomes, we encourage you to apply.
About Advanced Clinical:
Advanced Clinical is a global clinical development and strategic resourcing organization committed to improving patient lives through quality-driven clinical research solutions. We partner with pharmaceutical, biotechnology, and medical device companies of all sizes to accelerate their clinical development programs. At Advanced Clinical, we foster a collaborative, inclusive, and growth-oriented environment where our employees can thrive and make a meaningful difference.
Job Description:
As a Senior Clinical Data Associate, you will be a vital member of our clinical data management team, playing a crucial role in ensuring the accuracy, completeness, and quality of clinical trial data. You will leverage your experience to provide advanced-level support in data review processes, contribute to study management activities, and ensure compliance with Standard Operating Procedures (SOPs) and regulatory requirements. This role demands a proactive individual with excellent communication, organizational, and analytical skills.
Key Responsibilities:
- Exceed the expectations of a standard Clinical Data Associate by demonstrating expertise and taking ownership of assigned tasks.
- Assist in the creation and maintenance of key data management documents, including Data Management Plans (DMP), electronic Case Report Form Completion Guidelines (eCCGs), and edit check specifications.
- Conduct User Acceptance Testing (UAT) to ensure the functionality and integrity of Electronic Data Capture (EDC) systems.
- Support the integration of various EDC modules, such as electronic Patient-Reported Outcomes (ePRO), Interactive Voice/Web Response Systems (IVRS/IWRS), and dispensing systems.
- Perform comprehensive reviews of electronic Case Report Forms (eCRFs) to ensure completeness, accuracy, and data consistency.
- Conduct both manual and listing data reviews to identify discrepancies and potential data quality issues.
- Generate, manage, and resolve data queries, including issuing re-queries as needed.
- Effectively communicate data discrepancies and potential issues to the Data Management team for timely resolution.
- Reconcile Serious Adverse Events (SAEs) and data from external vendors to ensure data consistency across all sources.
- Identify data trends and report any inconsistencies or patterns that may require further investigation.
- Manage user accounts and study metrics to track progress and identify areas for improvement.
- Perform Quality Control (QC) reviews to ensure data integrity and adherence to established procedures.
- Execute EDC archival tasks in accordance with regulatory requirements and company SOPs.
- Ensure compliance with all applicable SOPs, Good Clinical Data Management Practices (GCDMP), and regulatory standards.
Qualifications:
- A minimum of 3 years of experience in clinical data management within the pharmaceutical or Contract Research Organization (CRO) industry is required.
- A Bachelor’s degree is preferred; however, relevant experience may be considered in lieu of a degree.
- A strong understanding of Clinical Data Acquisition Standards Harmonization (CDASH) standards is essential.
- Excellent communication, interpersonal, and organizational skills are critical for success in this role.
- A high degree of attention to detail and a strong commitment to data quality are paramount.
- Proficiency in using EDC systems (e.g., Medidata Rave, Oracle InForm) is highly desirable.
Why Join Advanced Clinical?
- Global Impact: Be part of an international organization dedicated to advancing clinical research and improving patient outcomes worldwide.
- Inclusive Culture: Thrive in a diverse and inclusive work environment that values collaboration, respect, and innovation.
- Growth Opportunities: Benefit from a growth-oriented environment with opportunities for professional development and advancement.
- Meaningful Work: Contribute to global clinical studies that have the potential to transform lives.
Job Location:
- Ahmedabad, Gujarat, India
- On-site Role
Salary (Estimated Range):
- INR 6,00,000 – 10,00,000 per annum (Based on skills and experience)
How to Apply:
If you are a qualified and enthusiastic Clinical Data professional seeking a challenging and rewarding opportunity, we encourage you to apply. Please submit your resume and cover letter through our online application portal. We look forward to hearing from you!
