[Hiring] Senior Clinical Trial Manager @Akero Therapeutics

Role Description

The Sr. CTM is a key member of Clinical Operations and will closely partner with the Clinical Program Manager and the EMEA Clinical Trial Manager in the oversight and conduct of the EMEA region.

• Assists Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation in conjunction with the EMEA CTM.
• Oversees and assists the EMEA CTM with:
  • Day-to-day contact with counterpart at CRO and/or trial site.
  • Daily review and identification of potential issues or problems with EMEA sites.
  • Timely completion of deliverables and proper issue resolution/escalation.
• Leads EMEA regional regulatory submission strategies and package review in collaboration with Regulatory Affairs and other operational team members.
• Proactively identifies potential operational challenges and provides solutions to ensure study execution remains on track.
• Under supervision, may serve as the key operational contact for Akero studies aiding in:
  • Site selection.
  • Study implementation.
  • Ongoing coordination of study sites, either directly or via CROs in EMEA region.
• Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures.
• Under supervision, may assist in review of:
  • Protocols.
  • Informed consents.
  • Case report forms.
  • Monitoring plans.
  • Abstracts, presentations, manuscripts, and clinical study reports.
• Reviews trip reports generated by CRO CRAs.
• Maintains study timelines.
• Coordinates review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.
• Provides regular study updates to the appropriate internal stakeholders.
• Maintains and reviews internal Clinical Operations databases and document repositories (including the study TMF).
• Performs administrative duties in a timely manner as assigned.
• Mentors junior team members and contributes to operational process improvements.

Qualifications

• 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 are required.
• Must be familiar with routine medical/scientific terminology.
• Must be familiar with Word, PowerPoint, and Excel (strong knowledge of Excel preferred).
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision.
• High energy level, personal productivity, creativity and commitment.
• Team-player desiring to work in a fast-moving, dynamic start-up environment.
• This position is for remote work, but may require domestic or international travel as required (valid travel documents must be obtainable).
• Strong knowledge of EMEA regulatory environment, submission processes, and timelines (e.g., EU CTR, MHRA, ANSM, etc.).
• Prior work in a small to mid-sized biotech or sponsor-side environment preferred.

Requirements

• Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
• Experience as the regional lead for Europe, United States, and/or India.
• Excellent attention to detail, verbal, written, interpersonal and presentation skills are required.
• Must be familiar with routine medical/scientific terminology.
• Must be familiar with Word, PowerPoint, and Excel.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision.
• High energy level, personal productivity, creativity and commitment.
• Team-player desiring to work in a fast-moving, dynamic start-up environment.
• This position is for remote work, but may require domestic or international travel as required (valid travel documents must be obtainable).

Benefits

• The base compensation range for this position is $120,300 to $222,600.
• Base compensation is determined based on a number of factors.
• This position is also eligible for a company bonus based on individual and company performance.
• Long-term incentive compensation depending on the position's level or other company factors.
• Eligible to participate in Company employee benefit programs including:
  • Medical, dental and vision coverage.
  • Life insurance.
  • Disability insurance.
  • 401(k) savings plan.
  • Flexible spending accounts.
  • Employee assistance program.
  • Tuition reimbursement program.
  • Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
• Time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy.