Job Description:
Department: Clinical Affairs
Job Title: Sr. Executive / Asst. Manager
Role: Clinical Data Management
Experience Required: 4–8 Years
Job Location: Corporate Office, Ahmedabad
Role Objective:
- A key objective of this position is to primary point of contact for EDC-related activities, responsible for overseeing the configuration, database design and user training of EDC systems. Creating and maintaining electronic case report forms (eCRFs) in alignment with clinical study protocols, ensuring accurate data collection, cleaning and reporting. The objective is to contribute to the efficient execution of data management plans and the overall success of clinical trials.
Desired Candidate Profile:
- Bachelor's degree in pharmacy or related field, with 4 to 8 years of experience in Clinical Data Management.
- Detail-oriented professional with comprehensive knowledge of EDC systems, database design and data management in clinical trials.
- Strong analytical and problem-solving skills, effective communication and the ability to collaborate with cross-functional teams.
- Prior experience in ensuring compliance with regulatory guidelines and optimizing data management processes is essential.
Role & Responsibilities:
- Serve as the primary point of contact for EDC-related activities, demonstrating in-depth knowledge of EDC systems.
- Create and maintain eCRFs in accordance with clinical study protocols, ensuring data accuracy and consistency.
- Contribute to the development and execution of data management plans aligned with study protocols.
- Oversee the setup and configuration of EDC systems, including designing eCRFs, edit checks, and data validation processes.
- Manage data queries and discrepancies, collaborating with study sites for timely resolution.
- Verify and validate clinical trial data for the database lock process, preparing documentation for regulatory submissions.
- Identify opportunities for process optimization, standardization and efficiency enhancement in data management practices.
- Ensure compliance with regulatory guidelines (EU MDR, USFDA, ANVISA, MDR 2017, TGA) and data management best practices.
- Archive clinical trial data as per relevant regulatory requirements.
- Work closely with cross-functional teams to ensure seamless data flow and communication throughout the trial.
- Perform other related duties as assigned.
Functional Skill Required:
- Comprehensive knowledge of EDC systems, configuration, and database design.
- Proficiency in creating and maintaining eCRFs aligned with clinical study protocols.
- Experience in data management plan development and execution.
- Strong skills in overseeing EDC system setup, edit checks, and data validation processes.
- Ability to manage data queries and discrepancies effectively.
- Verification and validation expertise for clinical trial data.
- Familiarity with regulatory guidelines (EU MDR, USFDA, ANVISA, MDR 2017, TGA) and data management best practices.
Behavioural Skill Required:
- Strong analytical and problem-solving skills.
- Effective communication and collaboration with study sites and cross-functional teams.
- Proactive identification of process optimization opportunities.
- Attention to detail and commitment to data accuracy.
- Compliance with regulatory guidelines and best practices.
- Ability to work in a dynamic and fast-paced environment.
Team Size to be Handled:
- Individual Contributor role, reporting to AGM – Clinical Affairs.
Important Links:
Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.