Sso Study Start-up Team Lead

2 weeks ago

Pasir Panjang, Singapore Novartis Full time

**Summary**:
LI-Hybrid
Location: Singapore

Are you ready to lead a high-performing team that drives the early success of clinical trials? At Novartis, we are looking for a passionate and experienced Study Start-Up Team Lead to join our Development organization in Singapore. In this pivotal role, you will oversee the governance and execution of study start-up activities, ensuring operational excellence and regulatory compliance across our clinical portfolio. If you thrive in a matrixed, fast-paced environment and are eager to make a meaningful impact on patients' lives, we want to hear from you.

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

- Lead and manage the end-to-end study start-up process from country allocation to site Green Light (ready-to-initiate).
- Support the development and execution of the country/OPC study start-up strategy in alignment with global and local priorities.
- Collaborate with internal stakeholders including Portfolio Heads, Global Study Teams, and Health Authorities to ensure timelines and deliverables are met.
- Ensure high-quality and inspection-ready Trial Master File (TMF) documentation throughout the study lifecycle.
- Drive innovation and continuous improvement in operational processes to enhance performance and productivity.
- Oversee hiring, training, development, and retention of Study Start-Up associates about 12 team members
- Serve as the escalation point for study start-up issues and ensure timely resolution.
- Ensure compliance with ICH/GCP, IRB/IEC, Health Authority regulations, and Novartis SOPs.
- Partner with SSU CRAs and global SSU managers to align on portfolio deliverables and essential document collection.
- Monitor and report on productivity targets and performance metrics.

**Essential Requirements**:

- Bachelor’s degree in a scientific or health discipline
- Minimum 5 years of experience in clinical operations and planning, with a strong focus on study start-up.
- Proven leadership experience, with or without direct line management responsibilities.
- In-depth understanding of clinical drug development, especially trial set-up and execution.
- Strong knowledge of international regulatory standards (ICH/GCP, FDA, EMA) and local Health Authority regulations.
- Experience working in a global or country matrix environment.
- Excellent interpersonal, negotiation, and conflict resolution skills.
- Strong communication skills in a cross-functional, multicultural environment.
- Ability to lead teams and drive results in a dynamic, high stakes setting

**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.

Division

Development

Business Unit

Innovative Medicines

Location

Singapore

Site

Mapletree Business City (MBC)

Company / Legal Entity

SG04 (FCRS = SG004) Novartis Singapore Pte Ltd

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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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