Contract - Senior Clinical Trial Manager

CONTRACT - SENIOR CLINICAL TRIAL MANAGER

Position Summary:

The Senior Clinical Trial Manager is a critical position within Global Blood Therapeutics' clinical team. In close collaboration with the VP Clinical Operations & Regulatory Affairs, the Sr. CTM will be responsible for the operational management of GBT's clinical trials. The Sr. CTM will partner with GBT's Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget.

Essential Duties and Responsibilities:

• 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
• Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)
• 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

Qualifications:

• BA/BS degree with at least 10 years clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 7 years clinical trial management 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 computer ability
• 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 effort
• Ability to travel up to 25%