Study Activation Manager

CTI Clinical Trial and Consulting Services; Raleigh (NC); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work from home

Health benefits

Vacation package

Parental leave

Job summary

CTI Clinical Trial and Consulting Services seeks a senior professional to lead global study start-up and site activation for assigned trials from strategy through execution. You will coordinate across feasibility, regulatory, site contracts, and clinical operations to ensure timely activation and TMF readiness.

Ideal candidates bring 8+ years in clinical research, expertise in start-up dependencies and regulatory submissions, and a proven ability to manage multiple trials across countries within

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years of clinical research experience, including start-up and site activation.
• Experience leading global start-up initiatives across multiple trials and countries.

Responsibilities

• Develop and lead global study start-up and site activation strategy for assigned trials, including activation assumptions, country/site sequencing, critical path dependencies, milestones, and mitigation plans.
• Establish and maintain country/site activation plans aligned with sponsor expectations, timelines, scope, and team priorities.
• Serve as primary operational point for study-start-up status, risks, escalations, and recovery planning.
• Partner with Feasibility, Clinical Operations, Regulatory Affairs, and country teams to support activation planning, submissions, and site readiness.
• Monitor activation metrics, dashboards, and project tracking to assess milestone progress, data quality, and cycle-time risks.
• Ensure TMF completeness, inspection readiness, and compliance with ICH/GCP and sponsor requirements.
• Provide concise start-up updates and decisions in governance and sponsor meetings.

Skills

Study start-up leadership

Site activation strategy

Cross-functional collaboration

Regulatory submissions

CTI SOPs knowledge

Education

Bachelor’s degree in life sciences

Master’s degree preferred

Job description

• 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 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.

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Equal Opportunity Employer/Veterans/Disabled