SSO Study Start-Up Manager

Midrand - South Africa

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

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 South Africa. 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.
May need to support the Start-Up Teams for Sub-Saharan African countries especially with regards to processes systems etc.

Job Description

Major accountabilities:

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
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 Start-up (SSU) CRA Clinical Project Manager and SSU Lead
Partners with SSU CRAs to drive all trial level start up activities including essential document collection

Key performance indicators:

Performance against study commitments at the country level (actual vs. planned patients) including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval Green Light SIV) and data quality requirements
Delivery of study milestones in adherence to prevailing legislation ICH/GCP IRB/IEC Health Authority and SOP requirements
Timely submission and delivery of high-quality clinical trial documentation/data

Minimum Requirements:
Work Experience:

A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management is preferable
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 aspects of drug development including strong knowledge of international standards (GCP/ICH) health authorities (FDA/EMA) local/National Health Authorities regulations
Experience and understanding of drug importation aspects an advantage

Skills:

Strong interpersonal negotiation and conflict resolution skills
Communicates effectively in a local/global matrixed environment
Effective time management
Regulatory Compliance.

Languages :

English.

Skills Desired

Clinical Research Clinical Trial Protocols Clinical Trials Clinical Trials Monitoring Decision Making Drug Development Health Sciences Life Science Regulatory Compliance

Required Experience:

Manager

Job Description SummarySSO 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 South Africa. Leads all SSU activities of assigned projects in close collab...