SSO Study Start-Up Manager

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.