Senior Clinical Trial Manager

Akero Therapeutics

. Assist the Clinical Program Manager with regional CRO and vendor setup .

Posted 9/29/2026full-timeRemote • United StatesSenior💰 $120,300 - $222,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial management, particularly in the EMEA region, with a strong focus on regulatory submission strategies, compliance, and operational efficiency. Proficient in coordinating site activities, mentoring team members, and maintaining study timelines while ensuring adherence to FDA and EMEA regulations.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory Submission StrategiesEMEA Regulatory EnvironmentAttention to DetailMentoring Team Members

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ExperienceRegulatory Document ReviewData Discrepancy ResolutionStudy Timeline MaintenanceProtocol ReviewInformed Consent ReviewCase Report Form ReviewMonitoring Plan ReviewClinical Study Report ReviewInterim/Final Clinical Study Report Coordination

Soft Skills

Verbal CommunicationWritten CommunicationInterpersonal SkillsPresentation SkillsProblem-Solving

Tools & Technologies

WordPowerPointExcelClinical Operations DatabasesDocument Repositories

Certifications & Qualifications

BS or BA in Relevant Scientific DisciplineRN Certificate

Industry Keywords

FDA RegulationsEMEA RegulationsICH GuidelinesGCPsEU CTRMHRAANSMPharmaceutical IndustryHealth Care IndustryBiotech Environment

About the role

Key responsibilities & impact

Assist the Clinical Program Manager with regional CRO and vendor setup
Liaise with Global CRO to ensure site training and timely initiation with the EMEA CTM
Oversee day-to-day CRO and trial-site contacts and identify potential EMEA site issues
Ensure timely completion of deliverables, issue resolution, escalation, and communication to the Clinical Program Manager
Lead EMEA regional regulatory submission strategies and package reviews
Identify operational challenges and provide solutions to keep study execution on track
Support site selection, study implementation, and ongoing site coordination in the EMEA region
Perform accompanied site visits with CRO CRAs and review regulatory documents for compliance
Assist with review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, clinical study reports, and investigator brochures
Review CRO CRA trip reports
Maintain study timelines
Coordinate data-listing reviews and interim/final clinical study reports, including resolving data discrepancies
Provide regular study updates to internal stakeholders
Maintain and review Clinical Operations databases and document repositories, including the study TMF
Perform assigned administrative duties
Mentor junior team members and contribute to operational process improvements

Requirements

What you’ll need

At least 6+ years of relevant experience and a BS or BA in a relevant scientific discipline, or at least 6+ years of experience and an RN (2 or 3 year certificate)
Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
Experience as a regional lead for ex-US (Europe preferred) required
Excellent attention to detail, verbal, written, interpersonal and presentation skills
Familiarity with routine medical/scientific terminology
Familiarity with Word, PowerPoint, and Excel; strong knowledge of Excel preferred
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinical trials desirable
Ability to participate in departmental or interdepartmental strategic initiatives under general supervision
Ability to travel up to 25%
Strong knowledge of EMEA regulatory environment, submission processes, and timelines, including EU CTR, MHRA, and ANSM
Prior work in a small to mid-sized biotech or sponsor-side environment preferred
Valid travel documents must be obtainable

Benefits

Comp & perks

Company bonus based on individual and company performance
Long-term incentive compensation
Medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Group legal insurance
Critical illness insurance
Identity theft protection
Pet insurance
Auto/home insurance
Sick time policy
Flexible vacation policy
Parental leave policy