Study Activation Manager

Ctifacts; Raleigh, Northern (NC, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work opportunities

Health benefits

Vacation packages

Paid parental leave

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services seeks a seasoned leader to drive global study start-up and site activation. You will set activation strategy, sequence countries/sites, and manage critical path dependencies, ensuring timely delivery across trials.

You will partner with Feasibility, Regulatory, Contracts, and Budgets teams to align plans with sponsor expectations. This role demands strong risk management, cross-functional influence, and robust governance communication.

Qualifications

• 8 years of clinical research experience with focus on study start-up and site activation.
• Experience leading global start-up across multiple trials and countries.
• Ability to forecast milestones, dependencies, and risks for activation plans.

Responsibilities

• Develop and lead global study start-up and site activation strategies.
• Establish activation plans aligned with sponsor expectations and timelines.
• Serve as operational lead for start-up status, risks, decisions and recovery.
• Partner with Feasibility, Regulatory, Contracts, and Budgets teams for readiness.
• Coordinate with PM and TMF teams to ensure milestone progress and reporting.
• Monitor metrics, data quality, and cycle-time risks and lead mitigations.
• Ensure compliance with ICH/GCP and CTI SOPs throughout start-up activities.

Skills

Study start-up leadership

Global activation strategy

Cross-functional alignment

Risk management

Project management

Executive communication

Stakeholder management

Decision making

Interpersonal leadership

Timeline forecasting

Education

Bachelor's degree in sciences

Tools

CTMS

Start-up tracking tools

Microsoft Office

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-startup 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 escalation 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 invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
• Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Equal Opportunity Employer/Veterans/Disabled

Equal Opportunity Employer
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