The Associate Director, Clinical Operations (Study Start Up) provides strategic and operational leadership for CRC's Study Start-Up function. This role leads and develops the Study Start-Up team and oversees start-up activities across clinical trials from study award through site activation. The position ensures activities are completed efficiently, consistently, and in accordance with timelines, budgets, quality standards, applicable regulations, ICH-GCP, CRC SOPs, and sponsor expectations. The Associate Director serves as a senior operational resource and partners with Clinical Trial Management, Clinical Operations, Project Management, Regulatory, Contracts, Quality Assurance, Clinical Monitoring, Data Management, sponsors, investigators, vendors and vendor management to support timely study activation.
Essential Duties and ResponsibilitiesPeople Leadership & Team Development- Lead, coach, mentor, and develop CRC's Study Start-Up team, promoting collaboration, accountability, ownership, and continuous improvement.
- Set clear expectations, goals, and performance standards; conduct regular one-on-ones, performance reviews, and development discussions.
- Identify strengths, development opportunities, training needs, and career-growth opportunities; support recruitment, interviewing, onboarding, and training of new staff.
- Monitor workload, resource allocation, and capacity needs; serve as an escalation point for operational, IRB, site, contracting, and budget issues.
- Manages sponsor-level escalations.
- Owns cross-functional alignment and process improvement.
Study Start-Up Oversight- Oversee study-specific start-up plans, timelines, milestones, documentation, site activation status, and outstanding deliverables.
- Oversee Study Start-Up activities from study award through site activation, ensuring clear responsibilities, timelines, deliverables, and escalation pathways.
- Coordinate country and site activation activities, including Confidential Disclosure Agreements (CDAs), feasibility, site identification/selection, IRB submissions, essential document collection, contracts, budgets, and related start-up activities.
- Partner with Project Manager (PM), Clinical Trial Managers (CTM), vendor management and relevant study team members to align start-up timelines with overall study milestones, identify bottlenecks, and implement mitigation strategies.
IRB, Site Activation, Contracts & Budgets- Provide oversight IRB/ethics submissions, including preparation, review, submission, tracking, and escalation of delays, deficiencies, or concerns.
- Ensure essential documents are collected, reviewed, and maintained in accordance with applicable requirements and site activation readiness expectations.
- Coordinate with Finance, Legal, and/or Sponsor regarding CDAs, Clincal Trial Agreements (CTAs)/site contracts and budget activities, monitor timelines, and identify barriers to activation to resolve issues.
- Maintain awareness of regulatory requirements and industry expectations affecting study start-up.
Feasibility & Site Selection- Provide overisght of site feasibility activities and partner with Clinical Operations and CTM to develop feasibility strategies as needed.
- Review feasibility results and recommend site selection and activation decisions considering patient population, recruitment potential, investigator experience, site capabilities, competing studies, and other relevant factors.
- Monitor feasibility performance and support recruitment and site activation strategies when appropriate.
Metrics, Reporting & Performance Management- Establish, monitor, and report Study Start-Up KPIs and operational metrics, including activation cycle time, IRB submission and approval timelines, contract/budget cycle times, essential document completion, milestone adherence, outstanding deliverables, and start-up risks/issues.
- Provide meaningful performance analysis to Operations leadership and use operational data to improve forecasting, predictability, and escalation thresholds.
Sponsor, Client & Cross-Functional Collaboration- Serve as a senior Study Start-Up contact for sponsors, support sponsor meetings/presentations, and communicate risks, delays, trends, and solutions proactively.
- Support CTMs, Project Managers and Study Start-Up staff in managing sponsor expectations and ensuring CRC delivers against contractual commitments.
- Partner with Clinical Operations, Clinical Monitoring, Regulatory, Quality Assurance, Vendor Managment, Finance, Data Management, and other functional groups to ensure effective communication and handoffs.
- Serve as a Study Start-Up subject matter expert and support proposal development, feasibility assessments, proposal presentation, client presentations, and business development activities as requested.
Quality, Compliance & Process Improvement- Ensure Study Start-Up activities comply with ICH-GCP, applicable regulations, CRC SOPs, protocols, contracts, and quality standards.
- Promote quality, inspection readiness, and appropriate documentation; support sponsor audits and regulatory inspections as needed.
- Partner with Quality Assurance to address quality events, findings, deviations, CAPAs, and related issues.
- Lead continuous improvement initiatives, standardize processes and best practices, and contribute to SOPs, work instructions, templates, tools, and technology improvements.
- Share lessons learned and support the continued growth and scalability of CRC's Study Start-Up organization.
- Other duties as assigned by management.
Qualifications- BS/BA degree in life sciences, healthcare, nursing, or related discipline; equivalent education, training, and experience accepted. Advanced degree preferred.
- 10 years of experience in clinical research, clinical operations, study start-up, regulatory operations, or a related field.
- Significant Study Start-Up experience in a CRO, pharmaceutical, biotech, or similar clinical research environment; small or mid-sized CRO experience preferred.
- Direct people-management experience, preferably managing Study Start-Up, Regulatory, Clinical Operations, or Site Activation professionals.
- Strong knowledge of study start-up processes from study award through site activation, including regulatory/IRB submissions, essential documents, site activation, feasibility, site selection, timelines, and site contracts/budgets.
- Strong knowledge of ICH-GCP, applicable clinical research regulations, cross-functional clinical trial operations, and quality expectations.
- Excellent written/verbal communication, interpersonal, organizational, analytical, problem-solving, and decision-making skills.
- Demonstrated ability to lead, coach, mentor, and develop clinical professionals.
- Ability to manage competing priorities, work independently, and collaborate effectively in a fast-paced, remote, cross-functional CRO environment.
- Ability to travel up to
Preferred:- CNS/neurology/neuroscience or psychiatric clinical trial experience.
- Management experience within a Study Start-Up department or team.
- Experience with US and/or global study start-up, regulatory submissions, IRB/IEC processes, site contracting, budget negotiations, feasibility, site identification, and site selection.
- Experience with sponsor audits, regulatory inspections, and risk-based quality management.
- Experience with clinical trial systems such as CTMS, eTMF/TMF systems,Monday.com, SharePoint, or similar platforms.
