job title: Clinical data management(desirous)

Roles and Responsibilities

Job description

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.

Preferred candidate profile

• Certification in clinical data management (like CCDM).

• Knowledge of CRF design, MS Project and analytical capabilities.

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

• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

• Understanding of data privacy and protection regulations (e.g., GDPR).

• Effective communication and interpersonal skills to collaborate with other teams.