What you'll do: - Develop and lead the global study start-up and site activation strategy for assigned trials, including activation assumptions, country and site sequencing, critical path dependencies, milestone projections, and mitigation plans.
- Establish, maintain, and communicate country and site activation plans in alignment with sponsor expectations, study timelines, project scope, and core study team priorities.
- Serve as the primary operational point of accountability for study-start-up and site activation status, risks, escalations, decisions, and recovery planning on assigned studies.
- Partner with Feasibility and Clinical operations to support site identification, site selection inputs, start-up projections, site readiness, and activation planning.
- Partner with Regulatory Affairs and country teams to support submission planning, document readiness, IRB/IEC or ethics committee requirements, approval dependencies, and site greenlight activities.
- Partner with Site Contracts and Budgets leads to monitor contract and budget status, identify barriers, escalate delays, and support timely resolution of activation dependencies.
- Coordinate with Project Management to align start-up milestones, scope assumptions, budget considerations, scope change needs, and sponsor commitments.
- Monitor activation metrics, dashboards, and project tracking systems to assess milestone progress, data quality and timeliness, cycle-time risks, and delivery commitments.
- Ensure timely and accurate start-up status reporting by appropriate team members to support sponsor updates, internal governance, and executive reporting.
- Identify and escalate start-up risks related to delayed sites, submission dependencies, essential document collection, contract or budget barriers, vendor dependencies, and resource constraints.
- Ensure start-up activities are conducted in accordance with International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), applicable regulations, sponsor requirements, CTI SOPs, and trial procedures.
- Ensure projections are established and fully vetted by internal and external stakeholders, updating them as material changes to actuals and assumptions occur.
- Promote Trial Master File (TMF) completeness, accuracy, and inspection readiness for study start-up deliverables.
- Coordinate with Feasibility and Clinical Operations to support site identification, site selection inputs, start-up projections, and activation planning.
- Monitor start-up resource needs and communicate resource, quality, or performance concerns to appropriate functional department heads and study leadership
- Provide concise start-up updates, risks, decisions, and action items during sponsor, governance, and internal project meetings.
- Prepare, oversee, or approve study start-up status reports, including milestone progress, risks, escalations, action items and recovery plans.
- Identify trends, lessons learned, and process improvement opportunities to strengthen operational consistency, cycle-time predictability, and sponsor confidence.
What you'll bring:- Experience leading global study start-up and site activation activities across multiple trials, countries, and functional partners.
- Strong understanding of global, country and site activation strategy, start-up dependencies, critical-path management, and milestone forecasting.
- Ability to interpret start-up metrics, identify risks or trends, and drive timely mitigation, escalation, and recovery planning.
- Excellent verbal and written communication skills, including experience presenting risks, decisions, and recommendations to senior internal leaders and sponsor teams.
- Ability to influence and align cross-functional stakeholders without direct authority.
- Ability to build strong client, peer, and cross-functional relationships through effective interpersonal and leadership skills.
- Ability to manage multiple trials, priorities, and sponsor deliverables accurately and efficiently.
- Strong organizational, documentation, record retention, and time management skills.
- Strong decision-making, critical thinking, and solution-focused problem-solving skills.
- Demonstrated accountability, follow-through, and ability to manage shifting priorities in a fast-paced clinical trial environment.
- Strong knowledge and clear understanding of CTI SOPs, sponsor requirements, ICH/GCP guidelines, and applicable regulatory requirements.
- Ability to clearly articulate site start-up and activation processes, SOPs, regulatory pathways, TMF expectations, and related procedures.
- Proficiency with clinical trial management systems, start-up tracking tools, and standard business software systems.
- Bachelor's degree in a scientific, health care, or related discipline, or equivalent experience.
- 8 years of clinical research experience, including significant experience in study start-up, site activation, clinical operations, or clinical trial management.
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