Clinical Research Medical Advisor

1 week ago

Mumbai Maharashtra, India Novartis Full time

**Summary**:
LI-Hybrid
Location: Mumbai / Hyderabad, India

About the Role:
As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials - this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning.

You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be critical to ensure good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams.

**About the Role**:
**Key Responsibilities**:

- Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards.
- Drive portfolio/trial medical feasibility within the Global Development framework and provide country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team.
- Identify and propose new sites for clinical trials, analyse capability, assess patient pool and country treatment landscape, and make recommendations for potential trial inclusion.
- Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed.
- Responsible for medical related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
- Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc.
- Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy.
- Support medical/clinical team discussions with local regulatory interactions as needed.

**Essential Requirements**:

- Medical Degree (MD, MBBS).
- Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements.
- Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.
- Outstanding internal and external stakeholder engagement experience.

**Commitment to Diversity and Inclusion / EEO paragraph**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams

representative of the patients and communities we serve.

**Accessibility and Accommodation**:
Division

Development

Business Unit

Universal Hierarchy Node

Location

India

Site

Mumbai (Head Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Alternative Location 1

Hyderabad (Office), India

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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