Clinical Data Sme

1 week ago

Hyderabad Telangana, India Novartis Full time

**Summary**:
**About the Role**:

- Provides feedback to assure well written protocols and amendments.
- Recognize and resolve protocol issues that may impact database design, data validation and /or analysis/reporting and that do not make the best use of available standards -Performs DM activities for start up of a study, Data Handling plan, Data Review Plan and performing user acceptance testing (UAT) -Manage local lab set up for the Clinical Database as applicable -Leads process and training deliverables within platform or processes.
- Accountable for all aspects of the Process and Training within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved.
- Accountable for all quality related aspects -Centralizes and aligns DO for audits and inspections.
- Manages and measures Quality -Coordinates exception requests, deviations and corrective /preventative action plans -Performs DM hands on activities during the course of the study Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable -Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation -Has proven abiity to use the tools available to generate listings for data review and where necessary provides these to the study teams.
- Generates the study status reports for use at Clinical trial team meetings.
- Supports and assists Junior staff for assigned trials -Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence -Leads /Coordinates synonym review activities and dictionary version upgrade activities at trial /Program level.
- Serves as primary study lead ensuring timely and quality deliverables by establishing and maintaining strong working relationships with study teams, and functional lines.
- Acts as a technical consultant as required.
- Lead DAP activities for assigned /Project level activities for phase I to IV clinical studies in Novartis Global Drug Development.
- Lead independently or participate in improvement initiatives and /or nonclinical projects.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Key performance indicators**:

- Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Data Mgmt activities and deliverables.
- No critical audit findings due to Data Mgmt -Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction

**Minimum Requirements**:
**Work Experience**:

- Cross Cultural Experience.
- Functional Breadth.
- Project Management.

**Skills**:

- Clinical Data Management.
- Data Governance.
- Data Integrity.
- Data Management.
- Data Quality.
- Data Science.
- Databases.
- Project Management.

**Languages**:

- English.

Division

Biomedical Research

Business Unit

Pharma Research

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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