Clinical Data Manager

Company Name: Clinvigilant Research Pvt. Ltd.(A company of GSC Group).

Job Title: Clinical Data Manager

Job Location: Ahmedabad- Onsite

No. of Position :01

Experience : 03 to 06 Years.

A Clinical Data Manager (CDM) plays a key role in managing and overseeing the data collected during clinical trials, ensuring its accuracy, integrity, and compliance with regulations. Here's a typical Job Description (JD) for a Clinical Data Manager

Job Summary:

The Clinical Data Manager oversees the collection, management, and quality control of clinical trial data. They will work closely with clinical research teams, statisticians, and regulatory authorities to ensure that data is accurately recorded, processed, and analyzed for clinical trials. The role involves ensuring that data is compliant with Good Clinical Practice (GCP) guidelines and relevant regulatory standards.

Key Responsibilities:

• Data Management Plan (DMP):
• Develop, implement, and maintain the Data Management Plan for clinical trials.
• Ensure that the DMP aligns with study protocols, regulatory requirements, and internal standards.
• Database Design & Development:
• Collaborate with clinical and statistical teams to design and build electronic data capture (EDC) systems and clinical databases.
• Perform user acceptance testing (UAT) to ensure that the systems are functioning properly.
• Data Collection & Verification:
• Oversee the collection and validation of clinical trial data, ensuring all data is accurate and complete.
• Ensure data consistency by reviewing the case report forms (CRFs) for completeness, accuracy, and compliance.
• Data Cleaning & Quality Control:
• Implement and manage data cleaning processes, including discrepancy management, query resolution, and follow-up on data errors.
• Coordinate with clinical sites and vendors to resolve data issues and discrepancies promptly.
• Reporting & Documentation:
• Prepare and maintain comprehensive documentation related to data management processes and outcomes.
• Ensure all clinical trial data is properly archived for future reference and regulatory compliance.
• Regulatory Compliance:
• Ensure compliance with GCP, ICH guidelines, FDA regulations, and other applicable regulatory bodies.
• Support regulatory submissions by providing high-quality data sets and related documentation.
• Collaboration & Communication:
• Collaborate with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and IT departments.
• Serve as the primary point of contact for data-related queries and provide data insights to stakeholders.
• Training & Mentoring:
• Train clinical data staff and ensure they are informed of current processes, systems, and regulatory requirements.
• Provide ongoing guidance and mentorship to junior data management staff.
• Vendor Management:
• Manage and coordinate relationships with third-party vendors, including EDC providers, CROs, and other partners.
• Ensure that external vendors adhere to the agreed-upon timelines and data quality standards.

Required Qualifications:

• Education:

Bachelor’s degree in Life Sciences, Computer Science, Statistics, or related field. A Master's degree or professional certifications (such as CDISC, GCP, or Clinical Data Management certifications) are advantageous.

• Experience:

3-5 years of experience in clinical data management or related field, with a strong understanding of clinical trial processes and data handling.

• Skills:
• Proficiency with clinical data management systems (e.g., Medidata Rave, Oracle, or similar platforms).
• Strong understanding of clinical data management concepts, regulatory requirements, and industry standards.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills for effective cross-functional collaboration.
• Ability to work under pressure and meet tight deadlines.

Preferred Qualifications:

• Experience working with complex clinical trials (multi-site, multi-region).
• Knowledge of regulatory submissions and reporting (e.g., FDA, EMA).
• Familiarity with statistical programming and data analysis tools (e.g., SASR).

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹50,000.00 per month

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• how you rate yourself in english proficiency( beginner/ average/ professional)?

Education:

• Bachelor's (Required)

Experience:

• CDM: 3 years (Required)

Location:

• Ahmedabad, Gujarat (Required)

Expected Start Date: 03/01/2022