Study Activation Manager

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 an...