Clinical Trial Manager Theraclone Sciences
Theraclone Sciences is a Seattle-based biotechnology company focused on the development of novel, therapeutic, human-antibodies for the treatment of infectious disease and cancer, and as a basis for vaccine development. Theraclone is a privately held company with venture investment from ARCH Venture Partners, Canaan Partners, Healthcare Ventures, MPM Capital, Amgen Ventures and Alexandria Real Estate Equities. For additional information, please visit www.theraclone-sciences.com
Theraclone is seeking a motivated and experienced Clinical Trial manager to plan, initiate and execute assigned clinical studies with operational excellence. The individual in this role will be accountable for effective management of budgets, timelines and resources for assigned clinical studies and implementation of appropriate standards and processes to ensure clinical study quality. This position will also be responsible for effective training and management of interactions with study team, study sites and vendors for assigned clinical studies.
The scope of this position is Phase 1 through 3 clinical studies. Primary duties and responsibilities include, but are not limited to:
? Assist in protocol development including protocol writing, participation in protocol writing committee, support medical in interactions with external KOLs, subject matter experts.
? Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
? Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities.
? Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.
? Conduct study monitoring visits and co-monitoring visits as needed.
? Provide regular updates of study progression to Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
? Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
? Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
? Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
? Lead feasibility assessment and selection of countries and sites for study conduct.
? Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
1124 Columbia St. Suite 300
Seattle, WA 98104
? Author, audit and/or edit written summaries of data reports, presentations, training material, and
? Ensure set-up and implementation of effective investigator and site monitor training; coordinate
operational and therapeutic area training for internal and external study team members.
? Provide oversight and direction to study team members, including vendors, for study deliverables.
? Coordinate with finance to track the financial status against budget.
The qualified candidate will have:
? BA/BS degree with at least 8 years clinical trial experience or advanced degree (MS/PhD/PharmD)
with at least 5 years clinical trial experience.
? Must have strong knowledge of ICH/GCP guidelines.
? Must have strong knowledge of protocol and clinical drug development processes, clinical study
design, study planning and management, and monitoring.
? Strong experience in management of CROs and other vendors.
? Requires proven project management skills and study leadership ability.
? Must have excellent interpersonal, written and verbal communication skills, administrative skills and
? Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project.
? Ability to ?roll up your sleeves? and individually contribute results to a research and development
? Ability to travel up to 25%.
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