Clinical Data Manager

Location: Pan India Experience: 3 8 Years

Education: Bachelor's or Master's Degree in Life Sciences, Pharmacy, Biotechnology, or related field Industry: Pharmaceuticals / Biotechnology / Clinical Research

About LatinumHR

LatinumHR is seeking to hire an experienced Associate Manager Clinical Data Management (AM-CDM) to oversee end-to-end clinical data management activities across clinical trials. The role involves leading data review and cleaning processes, coordinating with CROs and vendors, ensuring regulatory compliance, and supporting database lock and study close-out activities. This position requires strong leadership, data oversight expertise, and cross-functional collaboration to ensure high-quality and compliant clinical data delivery.

Key Responsibilities

Lead clinical data review, query management, and data cleaning activities across studies.

Ensure reconciliation of EDC, eCOA, external vendor data, and safety data including SAE reconciliation.

Support interim and final database lock activities, ensuring data accuracy and completeness.

Coordinate with CROs and external vendors to resolve data-related issues within timelines.

Maintain and review key documents such as DMP, CRF, and data review plans.

Ensure compliance with SOPs, ICH-GCP, and regulatory requirements (FDA, EMA).

Support audit and inspection readiness and maintain documentation in eTMF.

Oversee setup, testing, and validation of EDC, IRT, eCOA, and other data systems.

Mentor junior team members and support the CDM Lead in study-level planning and execution.

Ensure timely delivery of high-quality data management outputs aligned with study timelines.

Required Skills

Strong experience in Clinical Data Management within clinical trials.

Hands-on experience with EDC and electronic data capture systems.

Good understanding of clinical trial documents (Protocol, CRF, DMP).

Knowledge of ICH-GCP, FDA, and regulatory requirements.

Strong analytical skills and attention to detail.

Excellent communication and stakeholder management abilities.

Ability to manage multiple priorities and meet strict deadlines.

Proficiency in Microsoft Office tools.

Why Join Us

Opportunity to work on global clinical trials and regulatory submissions.

Collaborative and growth-oriented work environment.

Clear career progression toward CDM Lead and strategic data management roles.