Clinical Trial Manager

Summary

Elephas is a growing biotechnology company located in Madison, WI seeking a talented individual to join our team as a Clinical Trial Manager. The Clinical Trial Manager leads the planning, execution, and operational oversight of clinical studies supporting Elephas' oncology diagnostic platform. The role will manage clinical studies conducted in the United States and internationally, including CRO-supported trials in India and potentially other global markets.

The Clinical Trial Manager will work closely with Clinical Science, Regulatory, Quality, Biostatistics, Data Management, Laboratory Operations, and other teams. The Clinical Trial Manager ensures that studies are executed with quality, efficiency, and compliance with applicable requirements. The successful candidate is an independent, collaborative clinical operations professional with demonstrated experience managing CRO-led studies.

Essential Duties and Responsibilities

Clinical Study Management

• Manage day-to-day planning, start-up, execution, and closeout for U.S. and international clinical studies, including observational and biomarker validation studies.

• Develop and maintain study plans, timelines, enrollment milestones, risk assessments, and key operational deliverables.

• Coordinate the development, review, and implementation of protocols, amendments, study manuals, operational plans, training materials, and site-facing documents.

• Support implementation and maintenance of electronic data capture (EDC) systems, including study-specific database readiness, data entry timelines, query resolution, and database milestones.

• Monitor study progress and proactively resolve or escalate risks affecting quality, timelines, enrollment, or study objectives.

Clinical Sample and Data Management Coordination

• Coordinate with clinical sites, CROs, central laboratories, and internal teams to support the collection, processing, shipment, tracking, and analysis of clinical biospecimens.

• Support implementation of standardized procedures for fresh tumor biopsy collection and handling, with particular attention to specimen viability, transport requirements, and timely delivery to central laboratories.

• Oversee operational processes for tracking 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.

CRO and Vendor Oversight

• 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 agreed milestones and metrics, and drive issue resolution and corrective actions.

Budgets and Contracts

• Track and manage study budgets, forecasts, and vendor financial deliverables in collaboration with Clinical Development, Finance and internal stakeholders.

• Coordinate the 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 study scope or timeline changes.

Regulatory, Quality, and Clinical Data Oversight

• Coordinate with Regulatory, CROs, and in-country partners to support health authority and ethics committee submissions, approvals, amendments, and ongoing reporting.

• Oversee compliance with ICH-GCP, applicable country-specific requirements, study protocols, and company procedures.

• Support inspection readiness, Trial Master File (TMF) completeness, protocol deviation management, CAPA activities, and quality risk mitigation.

• Partner with Clinical Data Management and CRO teams to oversee electronic data capture (EDC) readiness, data quality, query resolution, data reconciliation, and database milestones.

• Coordinate oversight of specimen collection, processing, and logistics with CROs and laboratory partners.

Cross-Functional Coordination and Reporting

• Partner with Clinical Science, Biostatistics, Regulatory, Quality, Laboratory Operations, Data Management, R&D, and Finance to align study requirements and deliverables.

• Provide clear, timely updates to Clinical Affairs leadership on study status, budgets, risks, critical decisions, and vendor performance.

• Facilitate effective communication and issue resolution across internal teams and international study partners.

Education/Experience/Skills

• Bachelor's degree in life sciences, healthcare, or related field.

• Minimum of 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.

Competencies

• Strong sponsor-side clinical trial management, CRO oversight, and project leadership skills.

• Ability to manage multiple studies, budgets, priorities, and external stakeholders independently.

• 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.

Preferred Qualifications

• 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 a small biotechnology or diagnostics company.

We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.