01 Sep
|
Important Business
|
Navi Mumbai
01 Sep
Important Business
Navi Mumbai
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 robust 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.
📌 Manager - Clinical Data Services || CRO (Navi Mumbai)
🏢 Important Business
📍 Navi Mumbai