Study Activation Manager

Join The CTI Team•Raleigh, NC

17h•Hybrid

About The Position

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.

Requirements

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.

Responsibilities

Develop and lead the global study start-up and site activation strategy for assigned trials.
Establish, maintain, and communicate country and site activation plans.
Serve as the primary operational point of accountability for study-start-up and site activation status, risks, escalations, decisions, and recovery planning.
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.
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.
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.