Clinical Trial Manager

Location
South San Francisco, CA
Posted
Nov 17, 2021
Ref
4192854004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Clinical Trial Manager
 

Position Summary:


The Clinical Trial Manager is a critical position within Global Blood Therapeutics’ clinical team. In close collaboration with the Clinical Operations & Regulatory Affairs leadership, the CTM will be responsible for the operational management of GBT’s clinical trials. The 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.

Job 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, pharmacology, safety, regulatory affairs, clinical supply management, biometrics, legal, medical 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
  • Review monitoring visit reports and perform monitoring oversight 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 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 study vendor team
  • Lead feasibility assessment and selection of countries and sites for study conduct
  • Author, audit and/or edit 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

Job Requirements:

  • BA/BS degree with 5-8 years clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 2 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 trial management skills and study leadership ability
  • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
  • Ability to “roll up your sleeves” and individually contribute results to a research and development effort

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.