Sso Study Start-up Manager

391212BR

**SSO Study Start-Up Manager**:
Singapore

**About the role**

Internal Role Title: SSO Start-Up Manager
Location: Singapore #LI-Hybrid
About the Role:
The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation results of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager
Key Responsibilities:
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio and SSO Cluster Head Portfolio.
- Collaborates with SSO Country,Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and results are met according to country commitments
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects.
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable. Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required.
- Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs). Coordinates timely response to deficiency letters in close collaboration with local and global partners
- Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable. Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Implements innovative and efficient processes which are in line with Novartis strategy. Supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team. Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned.
- In satellite countries, coordinates local vendor selection and performance as needed. Serves as main contact for quality or compliance issues in SSU phase, bringing up as vital. Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light”
- Leads all aspects of local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
- Leads local SSU team meetings in assigned studies, participates in global study team meetings, as the need arises. Owns the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead.

**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._

**Role Requirements**

Essential Requirements:
- Proven experience in clinical operations in a role that coordinates (project management) and/or with supervising clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Strong project management capabilities with proven track record to problem solve and mediate sophisticated issues
- Detailed understanding of the international aspects of drug development process, including solid understanding of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills
- Communicates effectively in a local/global matrixed environment.

Why Novartis?

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes