Job Title: Associate / Senior Associate, Clinical Data Management (Remote – India)
Summary:
Are you a data-driven individual with a passion for clinical research and a keen eye for detail? We are seeking a highly motivated Associate or Senior Associate to join our Clinical Data Management team. This is a fully remote position based in India, offering an exciting opportunity to contribute to cutting-edge healthcare research while working from the comfort of your home. As a key member of our team, you will be responsible for managing clinical trial data, ensuring data integrity, and adhering to global regulatory standards. If you thrive in a dynamic environment and possess a solid understanding of clinical data management principles, we encourage you to apply!
About Us:
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Job Responsibilities:
As an Associate / Senior Associate, Clinical Data Management, you will play a crucial role in ensuring the quality and integrity of our clinical trial data. Your primary responsibilities will include:
- Stakeholder Management: Act as a primary point of contact for internal and external stakeholders, fostering clear and effective communication.
- Project Management: Manage data timelines, deliverables, and project milestones, ensuring projects are completed on time and within budget.
- Data Integrity: Ensure data integrity across Electronic Data Capture (EDC) and patient-reported outcome (ePRO) systems, maintaining the highest standards of data quality.
- Data Review and Query Management: Perform clinical and ePRO data reviews, manage queries, and reconcile data discrepancies to ensure accuracy and completeness.
- Database Management: Support database transfers, exports, and migrations, ensuring seamless data flow and accessibility.
- Documentation: Prepare essential documentation, including Data Management Plans, CRF specifications, and training materials, adhering to established guidelines and best practices.
- Site Support: Participate in Site Initiation Visits (SIVs) and site trainings, providing guidance and support to ensure proper data collection and management.
- User Acceptance Testing (UAT): Support User Acceptance Testing (UAT) and product launches, contributing to the successful implementation of new technologies and systems.
- Regulatory Compliance: Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, HIPAA, GDPR, FDA 21 CFR Part 11, and Annex 11 regulations, maintaining data privacy and security.
- Audit Support: Assist in audits and respond to compliance checks, ensuring adherence to regulatory requirements and internal policies.
- Innovation: Explore innovative approaches for remote clinical trial monitoring, contributing to the efficiency and effectiveness of our clinical trials.
Qualifications and Skills:
To be successful in this role, you should possess the following qualifications and skills:
Education:
- Undergraduate degree from an accredited university, preferably in Life Sciences, Pharmacy, Computer Science, or a related field.
Experience:
- 0-10 years of professional experience in clinical research, data management, or CRO roles.
- Exposure to observational research, registries, and clinical trial protocols.
- Familiarity with Electronic Data Capture (EDC), ePRO, EHR systems, and data standards (CDISC, SDTM, FHIR, OMOP).
- Knowledge of MedDRA and WHO Drug coding dictionaries.
- Strong project management, communication, and problem-solving skills.
- Excellent attention to detail and a commitment to data quality.
- Ability to work independently and collaboratively within a team environment.
Preferred Qualifications:
- Experience in rare diseases, gene therapy, or long-term follow-up studies.
- Previous work with central or specialty labs/vendors.
- Experience working with digital or mobile apps in clinical research.
Benefits of Joining:
We offer a comprehensive benefits package and a supportive work environment that fosters professional growth and development. As a member of our team, you will enjoy:
- 100% Remote Work: The flexibility to work from anywhere in India.
- Innovative Technology: Exposure to innovative digital health research tools.
- Collaboration: Opportunity to collaborate with biotech clients and global CRO teams.
- Career Growth: Opportunities for career growth in clinical data management and regulatory operations.
- Training and Development: Training and development in advanced healthcare technologies.
- Competitive Salary and Benefits: We offer competitive compensation and a comprehensive benefits package, including health insurance, paid time off, and retirement savings plans.
How to Apply:
If you are a highly motivated and experienced Clinical Data Management professional seeking a challenging and rewarding opportunity, we encourage you to apply. Please submit your resume and cover letter outlining your qualifications and experience.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.