Study Start-Up (SSU) Manager (4145)

Study Start-Up (SSU) ManagerThe Study Start-Up (SSU) Manager is responsible for overseeing and driving operational study startup activities across the clinical research network from study award through activation. This role ensures startup timelines, deliverables, dependencies, and cross-functional activities remain aligned to support efficient, compliant, and scalable study activation.

The Study Start-Up Manager serves as the primary operational lead for startup execution, coordinating closely with Regulatory, Clinical Operations, Clinical Data, sponsors, CROs, investigators, and site teams to maintain startup momentum and proactively address barriers impacting activation timelines. This role is responsible for startup performance oversight, milestone management, issue escalation, operational reporting, and process optimization to ensure consistent startup execution across the network.

DUTIES & RESPONSIBILITIES

1. Study Start-Up Operations & Activation Management

• a. Oversee and coordinate operational startup activities across assigned studies and network sites
• b. Drive startup timelines from study award through Site Initiation Visit (SIV) and activation readiness
• c. Maintain oversight of startup milestones, dependencies, deliverables, and critical path activities
• d. Ensure startup activities progress according to sponsor expectations and internal timelines
• e. Coordinate activation readiness across sites, vendors, sponsors, and internal departments
• f. Maintain startup trackers, activation reports, and milestone documentation
• g. Escalate delays, risks, or operational barriers impacting startup timelines

1. Cross-Functional Startup Coordination

• a. Coordinate closely with Regulatory, Clinical Operations, Clinical Data, PMO, and site teams throughout the startup lifecycle
• b. Ensure alignment between regulatory progress, operational readiness, and sponsor deliverables
• c. Facilitate startup meetings, milestone reviews, and escalation discussions
• d. Maintain clear communication across stakeholders regarding startup progress, risks, and priorities
• e. Partner with startup stakeholders to proactively resolve operational gaps or delays
• f. Coordinate sponsor, CRO, vendor, and site communications related to startup activities

1. Startup Performance Oversight & Reporting

• a. Monitor startup KPIs, activation timelines, and milestone adherence across studies and sites
• b. Identify startup bottlenecks, workflow inefficiencies, and operational risks impacting activation
• c. Track pending items, aging deliverables, outstanding approvals, and startup dependencies
• d. Provide regular startup status reports, escalation summaries, and operational updates to leadership
• e. Ensure startup reporting accuracy and visibility across systems and operational dashboards
• f. Support forecasting and startup pipeline visibility across the network

1. Risk Management & Escalation

• a. Identify and proactively address startup risks, delays, and operational barriers
• b. Escalate critical startup concerns impacting activation timelines or sponsor expectations
• c. Collaborate with stakeholders to develop mitigation strategies and action plans
• d. Monitor issue resolution timelines and ensure appropriate follow-through
• e. Support operational readiness and startup quality standards across all assigned studies

1. Process Optimization & Standardization

• a. Support continuous improvement of startup workflows, operational processes, and activation practices
• b. Assist with the development and maintenance of startup guidance documents, trackers, and workflow tools
• c. Promote consistency in startup execution, communication, and reporting practices across the network
• d. Support onboarding and training initiatives for startup staff and operational stakeholders
• e. Participate in process improvement initiatives focused on activation efficiency and operational scalability

1. Team Development, Training & Operational Readiness

• a. Support onboarding and operational training of new SSU team members
• b. Reinforce standardized startup workflows, escalation pathways, and operational expectations across the team
• c. Provide ongoing coaching and guidance related to startup processes, systems, sponsor expectations, and activation workflows
• d. Identify training gaps and operational development needs impacting startup execution or performance
• e. Promote accountability, consistency, and operational excellence within the SSU function
• f. Assist with the development and maintenance of startup training materials, process guides, and workflow documentation

1. Other Duties

a. Perform additional operational or leadership responsibilities as assigned by management

KNOWLEDGE & EXPERIENCE

Education

• Preferred: Bachelor's degree in Business Administration, Healthcare Administration, Life Sciences, or a related field
• An equivalent combination of operational experience and clinical research education may also be considered

Experience

• 5+ years of clinical research experience required
• 3+ years of direct experience in Study Start-Up, Site Activation, Clinical Operations coordination, or
• Regulatory startup support required
• Experience managing startup timelines, activation milestones, and cross-functional operational workflows required
• Experience working within a clinical research site network, CRO, sponsor, or multi-site research environment preferred
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