Clinical Data Management Specialist (Gandhinagar)

Biotech Healthcare; Gandhinagar; In loco; INR 800.000 - 1.150.000; Tempo pieno

Descrizione del lavoro

Biotech Healthcare in Ahmedabad seeks a Sr. Executive / Asst. to lead EDC activities, design eCRFs, and ensure clean data for clinical trials. You will oversee system configuration, data validation, and query resolution while collaborating with cross-functional teams to support regulatory submissions.

The role requires 4–8 years in Clinical Data Management, strong knowledge of EDC systems, and a focus on data integrity and compliance with EU MDR, USFDA, ANVISA, MDR 2017, and TGA guidelines.

Competenze

• Bachelor's degree in pharmacy or related field with 4–8 years in Clinical Data Management.
• Familiar with EDC systems, database design and data management in trials.
• Strong analytical and problem-solving skills; good communication.
• Experience ensuring regulatory compliance and data management optimization.

Mansioni

• Serve as primary contact for EDC activities and EDC system knowledge.
• Create and maintain eCRFs per study protocols with data accuracy.
• Contribute to data management plan development and execution.
• Oversee EDC system setup, edit checks and data validation.
• Manage data queries with study sites for timely resolutions.
• Verify and validate trial data for database lock and submissions.
• Identify opportunities to optimize data management processes.

Conoscenze

EDC systems knowledge

eCRF design

Data management planning

Regulatory compliance

Cross-functional collaboration

Analytical skills

Formazione

Bachelor's degree in pharmacy

Strumenti

EDC software

eCRF design tools

Descrizione del lavoro

Department: Clinical Affairs Job Title: Sr. Executive / Asst.

Manager Role: Clinical Data Management Experience Required: 48 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.

Key Links

• Website: https://biotechhealthcare.Com/
• LinkedIn: https://www.Linkedin.Com/company/biotechhealthcare/
• Instagram:

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