Sso Study Start-up Manager- Czech Republic

390524BR

SSO Study Start-Up Manager
- Czech Republic:
Czech Republic

About the role

Location: Novartis, Prague, Czech Republic #LI-Hybrid

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 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 backup and deputy of the country manager.

• 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 collaborators
• 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, advancing 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”
• 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/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
• Collaborate with global trial execution organization in support of Country SSU Lead to Global SSU managers for all portfolio results as needed
• Partners with SSU CRAs to drive all trial level start up activities including crucial document collection

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

Education:

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

Languages:

• Fluent in both written and spoken Czech and English

Experience/Professional requirement:

• Minimum 5 years’ experience in clinical operations in a role that coordinates (project management) and/or with monitoring clinical trials.
• Capable of leading in a matrix environment
• Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Strong interpersonal and conflict resolution skills
• Communicates effectively in a local/global matrixed environment

You’ll receive:
Why Novartis:
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Accessibility and accommodation:
Division

Development

Business Unit

GCO GDD

Work Location

Prague

Company/Legal Entity

NOV CZE

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No