Sr Executive / Lead - CDM (Clinical Data Management)

Vedic Lifesciences; Thane; Presencial; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Vedic Lifesciences Pvt Ltd. is seeking a seasoned Clinical Data Manager to oversee collection, validation and processing of trial data in India. You will design CRFs and EDC systems, develop DM procedures and ensure data quality across the lifecycle.

Your role requires knowledge of CDISC standards (SDTM/ADaM), GCP and strong collaboration with cross-functional teams to ensure accuracy and regulatory readiness of study data.

Formación

• Pharma/Life science graduate with 5–10 years of CDM experience in CRF design, MS Project and analytical capabilities.
• Knowledge of CDISC standards and data interchange formats (SDTM, ADaM).
• Effective communication and interpersonal skills to collaborate with other teams.
• Understanding Good Clinical Practice (GCP).
• Good execution and communication skills.

Responsabilidades

• Oversee collection, validation and processing of clinical trial data.
• Develop and implement data management procedures for trials.
• Support medical coding review for validity and completeness.
• Ensure compliance with regulations, protocols and SOPs in India.
• Maintain data quality from collection to database lock.
• Develop data management documentation (protocols, CRFs, data management plans).
• Design CRFs and EDC systems for data collection.
• Perform data entry and cleaning, including discrepancy management.
• Conduct data validation checks and implement quality control measures.
• Develop and execute SOPs for approval, data entry screen design and testing, validation tests and approval.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for clinical study reports.
• Serve as a primary or backup resource for data management issues.
• Ensure compliance with guidelines, GCP, CDISC standards and other regulations.
• Contribute to development and validation of data management software tools.

Conocimientos

CDM experience

CRF design

MS Project

Analytical capabilities

Interpersonal communication

CDISC standards

SDTM

ADaM

Educación

Pharma / Life science Graduate

Descripción del empleo

Role & responsibilities

• Overseeing the collection, validation and processing of clinical trial data.
• Developing and implementing data management procedures for clinical trials.
• Supporting and facilitating the review of medical coding for validity and completeness.
• Ensuring compliance with applicable regulations, protocols and standard operating procedures in India.
• Maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock.
• Stay updated on industry best practices, technological advancements and regulatory requirements related to clinical data management.
• Develop and maintain data management documentation, including study protocols, case report forms and data management plans.
• Design case report forms (CRFs) and electronic data capture (EDC) systems for data collection.
• Perform data entry and cleaning activities, including discrepancy management and query resolution.
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
• Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
• Collaborate with study team members to resolve data-related issues and discrepancies.
• Generate and review data listings, summaries and reports for clinical study reports.
• Serve as a primary or backup resource for issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the development and validation of data management software tools.

Preferred candidate profile

Pharma / Life science Graduate with 5-10 years of knowledge & experience CDM in CRF design, MS Project and analytical capabilities.

Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM)

Effective communication and interpersonal skills to collaborate with other teams.

Understanding Good Clinical Practice.

Good execution & communication skills.