Senior Clinical Trial Manager

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $120.3k - $222.6k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

📋 Description

• 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

• 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

• 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