Manager - Clinical Data Services || CRO

Manager - Clinical Data Services

Span of Control: Lead end-to-end Clinical Data Management activities for Phase IIV clinical studies

Qualification**:** Degree in Life Sciences/ Pharmacy/ Biotechnology/ Nursing/ Medicine

Post Qualification Experience**: 8–12 years in Clinical Data Management or Clinical Data Services**

Designation**: Manager**

Location**: Thane Belapur Road, Navi Mumbai**

Reporting to**:** Centre Head, VP of Clinics

JOB RESPONSIBILITIES

The incumbent will primarily be in charge of:

• Lead end-to-end clinical data management activities for Phase I–IV clinical studies.
• Ensure timely development, validation, and maintenance of study databases.
• Review study protocols and provide input on data collection strategies.
• Oversee Case Report Form (CRF/eCRF) design and annotation.
• Develop and review Data Management Plans (DMPs), Data Validation Plans, and Data Review Guidelines.
• Ensure database readiness, lock activities, and archival are completed as per project timelines.
• Manage multiple Clinical Studies /Clinical Trails simultaneously while ensuring adherence to timelines and quality standards.
• Oversee data cleaning activities, discrepancy management, and query resolution.
• Monitor data quality metrics and identify trends requiring corrective actions.
• Serve as the primary point of contact for sponsors, CROs, and internal stakeholders.
• Participate in project kick-off meetings, governance reviews, and client discussions.
• Provide regular project status updates and risk assessments.
• Build strong client relationships through proactive communication and high-quality delivery.

CANDIDATE PROFILE

Qualification

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, or related field.
• Master's degree (Life Sciences, Clinical Research, Public Health, or Healthcare Management) preferred.
• Certification in Clinical Data Management (e.g., CCDM) is an advantage.

Experience

• 8–12 years of experience in Clinical Data Management or Clinical Data Services.
• At least 2–3 years in a people management role.
• Experience managing global, multi-center clinical trials across Phase I–IV studies.
• Experience working with sponsors, CROs, or pharmaceutical/biotechnology organizations.