Study Start-Up (SSU) Manager (4145)

Job DetailsJob Location: Corporate SGA - HOUSTON, TX 77064The 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   2. 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   3. 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   4. 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   5. 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   6. 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   7. 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 Prior experience coordinating across Regulatory, Clinical Operations, sponsors, CROs, and site teams preferred Experience managing multiple concurrent studies and startup priorities in a fast-paced operational environment is required Previous experience in onboarding, training, or mentoring startup staff preferred Credentials: ACRP, SOCRA, PMP, or related clinical research/project management certification preferred Knowledge and Skills: Strong understanding of clinical trial startup workflows and site activation processes Working knowledge of IRB/EC processes, regulatory documentation, and essential startup requirements Strong operational coordination and project management capabilities Ability to manage multiple studies, competing priorities, and aggressive startup timelines simultaneously Strong organizational, analytical, and problem-solving skills Ability to identify operational risks, bottlenecks, and timeline impacts proactively Excellent verbal and written communication skills Strong stakeholder management and cross-functional collaboration abilities Ability to lead startup discussions, escalation meetings, and operational follow-up effectively Experience with CTMS, startup trackers, eRegulatory systems, or operational workflow platforms preferred Strong proficiency with Microsoft Office Suite, Google Workspace, reporting tools, and operational dashboards Ability to function effectively in a fast-paced, evolving, and metrics-driven operational environment Ability to coach and support team members while promoting accountability and operational consistency   KPI & Success Metrics Startup Timelines & Activation Performance Site Selection to Site Initiation Visit (SIV) Timeline: less than/equal to 15–20 days SIV to First Patient First Visit (FPFV): less than/equal to 30–45 days Startup Milestone Adherence: greater than/equal to 90% On-Time Study Activation Rate: greater than/equal to 90% Startup Timeline Variance Across Sites: less than/equal to 15% Startup Coordination & Operational Readiness Activation Readiness Prior to SIV: greater than/equal to 90% Essential Startup Deliverables Completed Prior to Activation: 100% Outstanding Startup Dependency Aging: less than/equal to 5 business days Startup Escalation Resolution Timeliness: less than/equal to 2 business days Cross-Functional Follow-Up Completion Rate: greater than/equal to 95% Operational Oversight & Reporting Startup Tracker/Data Accuracy: greater than/equal to 98% Reporting Timeliness & Status Update Compliance: greater than/equal to 95% Startup Risk Identification & Escalation Compliance: greater than/equal to 95% Sponsor/CRO Startup Communication Responsiveness: less than/equal to 1 business day average response time Process Consistency & Team Performance SOP/Workflow Adherence Across Startup Activities: greater than/equal to 95% New Team Member Onboarding & Training Completion: 100% within designated onboarding timeline Startup Process Deviation Reduction Year Over Year Team Task Accountability & Milestone Follow Through: greater than/equal to 95% Qualifications