Remote - India

Job Description

This position is responsible for coordinating and executing data management activities of a clinical trial. Responsibilities include supporting the development and maintenance of data management documentation, performing data quality and validation checks, reviewing and verifying data management deliverables, and collaborating with internal teams and external clients to ensure timely, accurate, and compliant clinical data delivery.

Responsibilities & Accountabilities

Independently manages data management activities for assigned clinical studies under general supervision.

Develops, reviews, and maintains Data Transfer Specifications (DTS) for incoming and outgoing clinical data.

Performs data extraction, transformation, cleansing, and formatting activities in accordance with approved data transfer specifications.

Develops, executes, and documents data validation and quality control checks to ensure data accuracy, completeness, and integrity.

Performs testing and verification of data management deliverables, including execution of test scripts and validation of outputs prior to production release.

Serves as the primary data management contact for routine study activities and communicates effectively with internal stakeholders and external clients under limited supervision.

Collaborates effectively across cross-functional teams to ensure timely completion of data management activities and resolution of data issues.

Consistently performs duties within established Policies, Standard Operating Procedures, Work Instructions, and Study Specific Procedures in accordance with current GxP standards and applicable regulations (e.g., Good Clinical Practices, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, HIPAA).

Performs other departmental or study-related duties as assigned.

Education & Experience

BS or MS in statistics, engineering, or equivalent.
3+ years prior industry experience in data programming activities.
Data programming experience in two or more of the following: Python, SAS, STATA, and R
Demonstrated successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting.
Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11
Proficient in Microsoft Word and Excel.
Excellent written and oral communication skills.
Strong organizational skills and attention to detail.
Ability to work with deadlines and manage multiple priorities.

Work Location: Remote – India

Candidates can send their CV to [HIDDEN TEXT]. Please feel free to reach out to HR Talent & Culture with any questions.

Data Manager - Excel

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