Associate Director, Clinical Operations (Clinical Trial Management)

Cognitive Research Corporation

8h•Remote

About The Position

The Associate Director, Clinical Operations provides strategic and operational leadership for CRC’s Clinical Trial Management team. This role manages and develops Clinical Trial Managers (CTMs), oversees clinical trial execution, supports issue resolution and risk mitigation, and helps ensure studies are delivered on time, within budget, and in compliance with protocols, contracts, ICH-GCP, applicable regulations, CRC SOPs, and quality standards. Associate Director partners with Clinical Operations leadership and cross-functional teams to strengthen Clinical Trial Manager capabilities, standardize best practices, and promote operational excellence for CRC’s sponsors.

Requirements

BS/BA degree in life sciences, healthcare, nursing, or related discipline; or equivalent education, training, and experience.
10 years of clinical research/clinical operations experience, including significant clinical trial management or project management experience.
Meaningful CRO experience; small or mid-sized CRO experience preferred.
Previous direct people-management experience, preferably managing CTMs, Clinical Project Managers, or similar clinical operations professionals.
Strong understanding of clinical trial execution from start-up through closeout, including timelines, risks, issues, vendors, budgets, deliverables, and cross-functional operations.
Strong knowledge of ICH-GCP and applicable clinical research regulations.
Experience working directly with pharmaceutical or biotech sponsors.
Demonstrated ability to lead, coach, mentor, and develop clinical operations professionals.
Excellent written, verbal, interpersonal, organizational, analytical, problem-solving, and decision-making skills.
Ability to manage competing priorities, work independently, and collaborate effectively in a fast-paced, remote CRO environment.

Nice To Haves

Advanced degree in a relevant scientific or healthcare discipline preferred.
CNS/neurology/neuroscience clinical trial experience.
Experience managing multiple CTMs or a CTM function.
Prior Experience as a CRA preferred but not required.
Phase I, II, and III clinical trial experience.
Sponsor audit, regulatory inspection, vendor management, CRO/vendor oversight, and risk-based quality management experience.
Experience with clinical study systems such as Monday.Com, CTMS, eTMF/TMF systems, and other clinical operations platforms.

Responsibilities

Lead, supervise, coach, and develop CRC CTMs; establish expectations, goals, and performance standards.
Conduct one-on-one meetings, performance reviews, and development discussions to strengthen leadership, communication, risk-management, and sponsor-management skills.
Identify training needs, growth opportunities, and support recruitment, interviewing, onboarding, and training of Trial Management staff.
Serve as an escalation resource for operational, sponsor, vendor, sites or study issues and promote a collaborative, accountable, solutions-oriented culture.
Manage CTM assignments, operational priorities, study-management decisions, and issue-resolution; escalating concerns related to quality, compliance, contracts, finance, or sponsor-relationships
Provide operational oversight of assigned CTM activities from start-up through closeout.
Ensure CTMs effectively manage timelines, milestones, deliverables, risks, issues, dependencies, vendors, CRO partners, investigators, and external stakeholders.
Review key study-management documentation, including study plans, timelines, risk assessments, status reports, mitigation plans, and contingency plans.
Monitor study performance and escalate significant delays, quality concerns, budget issues, and operational risks to leadership and relevant functions.
Partner with Project Management and Finance to manage study financial performance including budgets, resourcing utilization, forecasting, scope managements, and out-of-scope activities; supporting change orders and recovery plans when required.
Serve as a senior operational contact for sponsors and support CTMs in managing sponsor relationships, communications, and issue resolution.
Participate in sponsor meetings, governance meetings, project reviews, study team meetings, and escalation discussions as appropriate.
Partner with Project Management, Clinical Monitoring, Regulatory, Quality Assurance, Contracts, Finance, vendor management, Data Management, and other functions to promote communication, accountability, and contractual delivery.
Serve as a clinical trial management subject matter expert within CRC and represent Clinical Operations in cross-functional initiatives.
Partner with Clinical Operations and Project Management Leadership to assess current and future CTM resource needs, forecast for upcoming studies, and support prioritization across studies.
Monitor study assignments, workloads, and resource utilization; identify capacity constraints and recommend solutions.
Ensure clinical trials are conducted in accordance with ICH-GCP, applicable regulations, CRC SOPs, protocols, contracts, and quality standards.
Promote quality, inspection readiness, consistent documentation practices, and appropriate maintenance of essential study records and the TMF.
Partner with Quality Assurance and functional leaders to address quality events, deviations, risks, compliance concerns, and corrective and preventive actions.
Support sponsor audits, regulatory inspections, and inspection-readiness activities as needed.
Identify and implement improvements to Clinical Operations processes, tools, templates, workflows, systems, and standardized Trial Management practices, including Operations Work Management (OWM) powered by Monday.com and SharePoint.
Contribute to SOPs, work instructions, controlled documents, operational KPIs, and recommendations that improve quality, efficiency, and predictability.
Lead or participate in cross-functional process-improvement and organizational initiatives.
Provide Clinical Operations input into proposals, budgets, timelines, feasibility assessments, proposal presentations, client presentations, and strategic growth initiatives as needed.
Other duties as assigned by management.