Clinical Trial Manager

Location
San Diego, CA
Posted
May 23, 2018
Required Education
Bachelors Degree
Position Type
Full time

Job Description: 

Metacrine is a dynamic, driven emerging biotechnology company headquartered in San Diego, CA. The company is focused on advancing novel molecules for treatment of inflammatory and metabolic diseases.  

We are looking for a highly motivated individual to join the Clinical Development team as a Clinical Trial Manager (CTM) who will report to the Vice President of Clinical Operations. The CTM is responsible for the design and conduct of assigned clinical studies through clinical study report completion; managing Metacrine support staff (e.g., CRAs, Clinical Trial Assistants [CTA], etc.), consultants, and vendors; and ensuring ICH and GCP compliance.

Key Responsibilities:

  • Manage all study contractors, vendors (e.g., CROs), etc. including the invoicing and payment processes
  • Train, manage, and mentor project CRAs and CTAs
  • Ensure Clinical Operations, investigator, and vendor (CRO) compliance with relevant SOPs, GCPs and ICH guidelines
  • Manage, and perform as needed, all study startup, monitoring, and closeout activities
  • Facilitate relationships with all study stakeholders (e.g., internal Metacrine departments and team members, vendors, investigators, etc.) to ensure that each study is conducted efficiently, effectively, and in a timely manner
  • Train the study stakeholders, as needed
  • Ensure the trial master file (TMF) for each study is set-up, maintained, and in audit ready condition; manage documentation collection and review from study start-up to completion
  • Ensure that all relevant study documents and tools are prepared for each study (e.g., study startup documents, study logs, study reference manual, regulatory binders, etc.)
  • Oversee administrative issues for clinical studies including: all regulatory documents required for the initiation of clinical stidies, negotiating clinical budgets, processing contracts for vendors and individual study site agreements, reviewing scope of work with vendors and CROs
  • Identify site auditing frequency for compliance with applicable regulations and the monitoring requirements set up for a particular study, oversee efficiency and appropriateness of CRA travel, data monitoring and field performance
  • Develop and manage Data Management processes and vendors (CROs) through database lock (e.g., eCRF, data review, query process, etc.)
  • Set up and maintain accurate study status tracking tools and reports; report study progress and results to management, corporate partners, etc.
  • Manage the clinical supply chain once the supplies are released for use in the study
  • Coordinate and attend internal study meetings as assigned by Clinical Operations management
  • Coordinate external meetings (e.g., Investigator Meetings), conferences and events, as needed
  • Help with the preparation of project updates and presentations to stakeholders (e.g., generate data slides for PowerPoint presentations)
  • Approximate travel 25%, with higher travel during certain periods ​​​

Requirements:

  • Minimum 5 years’ experience in the biotechnology or pharmaceutical industry with significant site monitoring; experience in gastroenterology or hepatology preferred
  • BS degree in a health-related science or equivalent (e.g., nursing)
  • Proficient knowledge of GCP and ICH and medical terminology
  • Mature, hard-working, team player that thrives in a fast-paced working environment
  • Ability to prioritize and multitask to ensure tasks are completed on or ahead of time
  • Strong interpersonal and written communication skills
  • Excellent organizational and planning skills with attention to detail
  • Advanced Microsoft Office proficiency including Word, Outlook, Excel, and PowerPoint; high computer literacy and ability to learn new software; ability to assemble scientific data for PowerPoint presentations (e.g., figures, tables, etc. obtained from study database)