Study Start Up Manager

The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables 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.
Accountabilities What are the key deliverables and accountabilities of the role?

Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio
Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables 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 stakeholders
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 oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
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”
Oversees 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/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required
Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead

Activities & Interfaces How does this role operate within, interact with and impact the organization?
Interfaces with global trial execution organization in support of Country SSU Lead to Global SSU managers for all portfolio deliverables as needed.
Partners with SSU CRAs to drive all trial level start up activities including essential document collection.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable

Fluent in both written and spoken English, local language as needed

Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports
Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring

Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
Thorough understanding of the international aspects of drug development process, including strong knowledge 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

**Division**

Global Drug Development

**Business Unit**

REG AFFAIRS GDD

**Country**

Austria

**Work Location**

Vienna

**C