Company
SSOStudyStart-UpManager
Neural analysis suggests this role is
optimal for Mid+ candidates.
“SSO Study Start-Up Manager. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, study planning, SSU activities, activation deliverables, GCP/ICH, regulatory requirements, country commitments, start-up activities, IRBs/IECs, Health Authorities, Informed Consent Forms, Regulatory Affairs/CTA Hub, Health Authorities submissions, local submission package, EU-CTR, amendments, IBs, DSURs, CSRs, defici”
What You'll Achieve.
timely start-up activities from country allocation until Green Light (ready to initiate site milestone); ensure SSU timelines and deliverables are met according to country commitments; ensure that study start-up activities are conducted and completed on time; ensure TMF inspection readiness
Industry & Context.
conflict resolution skills
What They're Looking For.
Must Have
degree in scientific or health discipline required, 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
Nice to Have
advanced degree with clinical trial experience and/or project management, is preferable, interpersonal, negotiation and conflict resolution skills, Communicates effectively in a local/global matrixed environment
What You'll Do.
activation deliverables
ensure SSU timelines and deliverables are met
timely start-up activities
ensure close collaboration with local IRBs/IECs and Health Authorities
ensure that study start-up activities are conducted and completed on time
preparation and review of Informed Consent Forms
engaging Regulatory Affairs/CTA Hub for Health Authorities submissions
Prepare and finalises local submission package for submission to IRB/IEC
CTA Hub (Europe: according to new EU-CTR) as well as Health Authorities
Coordinate timely response to deficiency letters
Coordinate reportable events and notifications to IRB/IEC and Health Authorities
Accountable for timelines
and quality of country TMF documents in study start-up
How You'll Work.
Team & Collaboration
close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager; 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; close collaboration with local IRBs/IECs and Health Authorities; close collaboration with local and global stakeholders
Communication Scope
Communicates effectively in a local/global matrixed environment
Process & Methodology
project management, Project Planning, Waterfall Model
Full Job Description
**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, accu
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