Study Start-Up (SSU) Manager (4145)

DM CLINICAL RESEARCH GROUP•Houston, TX

3d•Onsite

About The Position

The 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.

Requirements

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 managing multiple concurrent studies and startup priorities in a fast-paced operational environment is required
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
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

Nice To Haves

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 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
Previous experience in onboarding, training, or mentoring startup staff preferred
ACRP, SOCRA, PMP, or related clinical research/project management certification preferred
Experience with CTMS, startup trackers, eRegulatory systems, or operational workflow platforms preferred

Responsibilities

Oversee and coordinate operational startup activities across assigned studies and network sites
Drive startup timelines from study award through Site Initiation Visit (SIV) and activation readiness
Maintain oversight of startup milestones, dependencies, deliverables, and critical path activities
Ensure startup activities progress according to sponsor expectations and internal timelines
Coordinate activation readiness across sites, vendors, sponsors, and internal departments
Maintain startup trackers, activation reports, and milestone documentation
Escalate delays, risks, or operational barriers impacting startup timelines
Coordinate closely with Regulatory, Clinical Operations, Clinical Data, PMO, and site teams throughout the startup lifecycle
Ensure alignment between regulatory progress, operational readiness, and sponsor deliverables
Facilitate startup meetings, milestone reviews, and escalation discussions
Maintain clear communication across stakeholders regarding startup progress, risks, and priorities
Partner with startup stakeholders to proactively resolve operational gaps or delays
Coordinate sponsor, CRO, vendor, and site communications related to startup activities
Monitor startup KPIs, activation timelines, and milestone adherence across studies and sites
Identify startup bottlenecks, workflow inefficiencies, and operational risks impacting activation
Track pending items, aging deliverables, outstanding approvals, and startup dependencies
Provide regular startup status reports, escalation summaries, and operational updates to leadership
Ensure startup reporting accuracy and visibility across systems and operational dashboards
Support forecasting and startup pipeline visibility across the network
Identify and proactively address startup risks, delays, and operational barriers
Escalate critical startup concerns impacting activation timelines or sponsor expectations
Collaborate with stakeholders to develop mitigation strategies and action plans
Monitor issue resolution timelines and ensure appropriate follow-through
Support operational readiness and startup quality standards across all assigned studies
Support continuous improvement of startup workflows, operational processes, and activation practices
Assist with the development and maintenance of startup guidance documents, trackers, and workflow tools
Promote consistency in startup execution, communication, and reporting practices across the network
Support onboarding and training initiatives for startup staff and operational stakeholders
Participate in process improvement initiatives focused on activation efficiency and operational scalability
Support onboarding and operational training of new SSU team members
Reinforce standardized startup workflows, escalation pathways, and operational expectations across the team
Provide ongoing coaching and guidance related to startup processes, systems, sponsor expectations, and activation workflows
Identify training gaps and operational development needs impacting startup execution or performance
Promote accountability, consistency, and operational excellence within the SSU function
Assist with the development and maintenance of startup training materials, process guides, and workflow documentation
Perform additional operational or leadership responsibilities as assigned by management