20 Oct
|
Sun Pharmaceutical Industries
|
Gurugram
20 Oct
Sun Pharmaceutical Industries
Gurugram
Title :Sr. Manager - Clinical Data Management**:
- Date: Jul 27, 2026
- Location: Gurgaon - R&D;
- Company: Sun Pharmaceutical Industries Ltd
Job Summary
- The incumbent is responsible for effectively supervising junior Data Management staff as well as the quality of work
- performed for all studies. Wider responsibilities include in-depth understanding of stakeholder expectations and
- project deliverables, providing and maintaining vendor relationships on behalf of the company and for the department.
- The Data Project Lead will continue to perform as a Lead Data Manager on multiple global/local studies and will act as
- a line supervisor.
- Area Of Responsibility
- 1. Employee is accountable for the quality of work performed.
- 1. Independently perform all work to meet DM Management and stakeholders’ expectations.
- 1. Assists and coordinates the activities of junior Data Management Staff to provide support to operational
- milestones and resource planning across all direct reports’ projects to meet high quality data delivery.
- 1. Responsible for the overall consistency and efficiency across all projects assigned as well as managed by the
- direct reporting staff. Supports and executes, all activities centered on development and maintenance of
- Data Management Plan (DMP), eCRF design, data collection, data retrieval, coding, and query management.
- 1. Accountable for the performance of effective key performance metrics management for all assigned and all
- direct reports’ projects.
- 1. Manages junior DM staff and supports projects undertaken by the direct reporting staff, including but not
- limited to administrative oversight for CV/JD/SOP completion and Timesheet/Time-offs submission and
- approval in a timely manner. Ensures adherence to corporate procedures and policies. Ensures all project
- related agreements are comprehensive, accurate and complete.
- 1.
Demonstrates corporate core competencies at the management level; exhibits corporate values.
- 1. Reports on quality and performance metrics, including timelines, to DM Management. Participates in the
- organization and presentation of in-house and external training courses.
- 1. Works in strict adherence to SOPs and other applicable standards in compliance with Sun Procedural
- Documents, ICH-GCP and local regulations.
- 1. Reviews, freezes and locks data in accordance with DM control documents for accuracy, completeness,
- consistency, and validity, generate and submitted queries as necessary to investigation sites, as well as the
- project team at large.
- 1. Produces and/or coordinates reports and listings for team reviews and DSMBs (Data Safety Monitoring
- Boards).
- 1. Codes medical terminology, such as Adverse Events, Medical History, and Concomitant Medications, as
- appropriate and if required.
- 1. Develops and coordinates to finalize third party vendor Data Transfer Plans (DTP) for electronic database load
- to and from the company.
- 1. Performs ongoing reconciliation, including but not limited to SAE/AE, Electronic Data Loads and third party
- data such as central lab, IRT, against the clinical database and tracks issues to resolution.
- 1. Following CDISC conventions, oversee and perform EDC build activities including database design
- specifications; eCRF design and annotation, generation of data edit checks and data validations and data
- transfer specifications.
- Geographic Scope/ Market Global
- Budget (if applicable)
- Work Conditions: Full time
- Physical Requirements: Presence at work
- Travel Estimate Infrequent
- Education and Job Qualification
- Masters or Bachelors degree in Life Sciences and allied disciplines. Relevant skilled certifications and credentials
- preferred
- Experience
- Should have 10 or more years of experience in a similar capacity with minimum 2 years of line management
- experience
📌 Sr. Manager - Clinical Data Management (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram