Clinical Trial Manager

Elephas•Madison, WI

About The Position

Elephas, a growing biotechnology company located in Madison, Wisconsin, is seeking a Clinical Trial Manager to lead planning, execution, and operational oversight of clinical studies supporting its oncology diagnostic platform. The role manages U.S. and international studies, including CRO-supported trials in India and potentially other global markets, and collaborates with Clinical Science, Regulatory, Quality, Biostatistics, Data Management, Laboratory Operations, and other teams. The manager ensures studies are conducted efficiently and with quality and compliance with applicable requirements. The position oversees study planning, start-up, execution, closeout, study documents and timelines, electronic data capture readiness and milestones, clinical biospecimen logistics, and collection of clinical outcomes. It also supports CRO and vendor selection and oversight; coordinates budgets, contracts, and financial tracking; and works with Regulatory, CROs, and in-country partners on health authority and ethics committee activities. The role supports GCP compliance, inspection readiness, Trial Master File completeness, protocol deviation management, CAPA activities, data quality, and cross-functional reporting. The successful candidate is an independent, collaborative clinical operations professional with demonstrated experience managing CRO-led studies.

Requirements

Bachelor's degree in life sciences, healthcare, or a related field.
At least 5 years of experience in clinical research, including independent clinical trial or project management responsibilities at a sponsor or CRO.
Demonstrated experience overseeing CROs and external vendors, including deliverables, timelines, performance, and operational escalations.
Experience coordinating clinical study budgets, contracts, study start-up, and regulatory or ethics committee activities.
Working knowledge of GCP, clinical trial documentation, and clinical study quality requirements.
Strong sponsor-side clinical trial management, CRO oversight, and project leadership skills.
Ability to independently manage multiple studies, budgets, priorities, and external stakeholders.
Working knowledge of ICH-GCP and international clinical trial operations and regulatory coordination.
Sound judgment in identifying operational risks, driving decisions, and escalating issues appropriately.
Excellent written, verbal, presentation, and cross-cultural communication skills.
Ability to interpret scientific and clinical information and collaborate with multidisciplinary teams.
Proficiency with Microsoft Office and familiarity with EDC, CTMS, and electronic TMF systems.

Nice To Haves

Experience managing international clinical studies, including studies conducted in India or other global research markets.
Experience in oncology, solid tumors, biomarker validation, diagnostics, or observational research.
Experience working in a sponsor-side role or at a small biotechnology or diagnostics company.

Responsibilities

Manage day-to-day planning, start-up, execution, and closeout of U.S. and international clinical studies, including observational and biomarker validation studies.
Develop and maintain study plans, timelines, enrollment milestones, risk assessments, and operational deliverables.
Coordinate development, review, and implementation of protocols, amendments, study manuals, operational plans, training materials, and site-facing documents.
Support EDC implementation and maintenance, including database readiness, data-entry timelines, query resolution, and database milestones.
Monitor study progress and proactively resolve or escalate risks to quality, timelines, enrollment, or study objectives.
Coordinate with clinical sites, CROs, central laboratories, and internal teams on collection, processing, shipment, tracking, and analysis of clinical biospecimens.
Support standardized procedures for fresh tumor biopsy collection and handling, including specimen viability, transport requirements, and timely delivery to central laboratories.
Oversee tracking of biospecimen collection, shipment, receipt, sample adequacy, and reconciliation with clinical data.
Work with Clinical Science, Data Management, and CRO partners to ensure timely and accurate collection of clinical outcomes, including imaging assessments, treatment response, and follow-up data.
Support CRO and vendor selection, feasibility assessments, scopes of work, onboarding, and performance evaluations.
Serve as the primary sponsor-side operational contact for international CROs, laboratories, imaging providers, and other study vendors.
Oversee CRO-managed site selection, activation, training, monitoring, recruitment, and sample collection activities.
Lead routine CRO governance meetings, track performance against milestones and metrics, and drive issue resolution and corrective actions.
Track and manage study budgets, forecasts, and vendor financial deliverables with Clinical Development, Finance, and internal stakeholders.
Coordinate review and negotiation of CRO agreements, study and site budgets, vendor contracts, and change orders with Legal and authorized approvers.
Monitor spending, invoices, budget variances, and financial impacts of changes to study scope or timelines.
Coordinate with Regulatory, CROs, and in-country partners on health authority and ethics committee submissions, approvals, amendments, and ongoing reporting.
Oversee compliance with ICH-GCP, country-specific requirements, study protocols, and company procedures.
Support inspection readiness, TMF completeness, protocol deviation management, CAPA activities, and quality risk mitigation.
Partner with Clinical Data Management and CRO teams to oversee EDC readiness, data quality, query resolution, data reconciliation, and database milestones.
Coordinate oversight of specimen collection, processing, and logistics with CROs and laboratory partners.
Partner with Clinical Science, Biostatistics, Regulatory, Quality, Laboratory Operations, Data Management, R&D, and Finance to align study requirements and deliverables.
Provide Clinical Affairs leadership with timely updates on study status, budgets, risks, critical decisions, and vendor performance.
Facilitate communication and issue resolution across internal teams and international study partners.