Job Opening: Associate Director Study Data Manager
Position Overview
Join us as an Associate Director Study Data Manager, where you will take the lead in coordinating Clinical Data Management (CDM) deliverables for assigned clinical studies. As a crucial member of the Global Study Team (GST), you will serve as the primary point of contact for the Data Management (DM) vendor. Your role will ensure that CDM deliverables adhere to standards and maintain high data quality. This position is essential for upholding business continuity in CDM processes and standards, safeguarding the integrity of clinical databases for relevant studies.
Job Responsibilities
As an Associate Director Study Data Manager, your key responsibilities will include:
- Coordination and Leadership: Oversee the CDM deliverables on assigned studies, acting as the first point of contact at the study level.
- Risk Management: Identify potential risks and collaborate with the DM Vendor to mitigate them effectively.
- Regulatory Support: Provide input into DM-related activities for regulatory inspections and audits for assigned studies.
- Vendor Oversight: Monitor and manage DM Vendor performance to ensure adherence to standards and timelines.
Candidate Profile
We are looking for candidates who meet the following qualifications:
- Education: University or college degree in life sciences, pharmacy, nursing, or a related field.
- Experience: Solid knowledge of Clinical Data Management with experience in the Biotech/Pharma/CRO industry.
- Regulatory Knowledge: Current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
- Project Management: Strong project management skills with expertise in metrics analysis and reporting methodologies.
- Collaboration: Proven ability to work effectively with external partners.
- Technical Skills: Experience with clinical databases, various clinical data management systems, and electronic data capture (EDC).
- Process Knowledge: Understanding of query management processes and reconciliation activities.
- Communication: Excellent written and verbal communication skills, with strong problem-solving abilities.
- Independence: Ability to work independently with minimal supervision.
- Teamwork: Ability to thrive in a global team environment.
- Organizational Skills: Exceptional organizational and analytical skills, sound decision-making abilities, and high attention to detail.
- Drug Development Knowledge: In-depth knowledge of clinical and pharmaceutical drug development processes.
- Technical Proficiency: Advanced understanding of database structures, programming languages, data standards (CDISC), and practices related to CRF design, database development, data handling, and reporting.
- System Design: Experience in clinical data system design, development, validation, and interoperability.
- Professionalism: Demonstrates professionalism, diplomacy, mutual respect, and the ability to manage and value diversity and cultural differences, promoting productivity through encouragement.
- Regulatory Experience: Experience within a sponsor organization and regulatory inspections.
Location
This position is based in Bangalore, India.
If you are a dedicated professional with a strong background in Clinical Data Management and looking to make a significant impact in a leading biopharmaceutical company, we invite you to apply for the role of Associate Director Study Data Manager. Join us in our mission to advance health through innovative science and excellence in data management.
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