About the role

Job Description Summary

Internal Role Title: Clinical Research Associate Manager

Location: Singapore #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

About the Role:

We are seeking a highly skilled and experienced individual to join our team as a Clinical Research Associate (CRA) Manager & Monitoring Services Oversight Manager. This dual role involves overseeing the performance and development of CRAs, managing vendor relationships, and ensuring the quality and compliance of monitoring activities in clinical trials. The ideal candidate will have a strong background in clinical research, excellent leadership capabilities, and the ability to manage multiple responsibilities effectively.

Job Description

Key Responsibilities:-

Oversee CRA performance, development, and coaching to ensure delivery, productivity, and quality performance indicators
Manage and allocate CRA resources to studies and sites, ensuring balanced workloads and quality monitoring
Monitor and approve CRA travel and expenses to ensure compliance with T&E policy and budget
Collaborate with SSO Clinical Project Managers to support recruitment strategies and site performance
Ensure timely communication with vendors and align resource needs and expectations
Oversee vendor monitoring performance targets, including site recruitment commitments, timely data entry, and issue resolution
Support clinical development audits, site audits, and inspections, ensuring CAPA follow-up and implementation.

Essential Requirements :-

A degree in a scientific or health discipline; an advanced degree is preferable
Minimum 7 years of experience in clinical research, including planning, executing, and monitoring clinical trials
Strong project management and team leadership capabilities
Thorough understanding of clinical drug development, international standards (GCP/ICH), and health authority regulations
Excellent communication, negotiation, and conflict resolution skills
Ability to travel domestically and internationally as needed
Proficiency in digital and technological tools

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

Budget Management, Clinical Research, Clinical Study Reports, Clinical Trials, Clinical Trials Monitoring, Communication, Data Analysis, Decision Making, Health Sciences, Life Science, People Management, Regulatory Compliance

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

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About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.