SSO Study Start-Up Manager

Job Description Summary

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.

 

Job Description

Key responsibilities but not limited to:

• Support country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio.

• Collaborate 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 milestone) in assigned projects.

• Ensure close collaboration with local IRBs/IECs and Health Authorities as applicable.

• Ensure that study start-up activities are conducted and completed on time, including preparation and review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required.

• Prepare and finalises local submission package for submission to IRB/IEC, CTA Hub (Europe: according to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs).

• Coordinate timely response to deficiency letters in close collaboration with local and global stakeholders.

• Coordinate reportable events and notifications to IRB/IEC and Health Authorities, e.g. substantial and non-substantial amendments, IB updates, ICF updates as applicable, including preparation, update, and review of submission documents.

• Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness.

Essential criteria:

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

• Strong 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

Desirable criteria:

• Strong interpersonal, negotiation and conflict resolution skills.

• Communicates effectively in a local/global matrixed environment.

 

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model