Sr. Clinical Trial Manager

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

Job Responsibilities

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 the following: day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with EMEA sites. Oversees and assists the EMEA CTM in timely completion of deliverables and proper issue resolution/escalation and communicates/escalates to Clinical Program Manager.
Leads EMEA regional regulatory submission strategies and package review in collaboration with Regulatory Affairs and other operational team members (e.g., CTA, EC/RA submissions, responses, and approvals).
Proactively identifies potential operational challenges and in collaboration with senior team members 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 and 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, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
Review of 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.
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.

Physical Requirements

Ability to travel up to 25%.
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

Relevant Experience:

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).