Company
SSOStudyStartUpManager
“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
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