(Senior) Clinical Trial Associate - TMF

Location
San Francisco, California
Posted
Sep 07, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
About Navire Pharma & BridgeBio Pharma

Navire Pharma, an affiliate of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://navirepharma.com | https://bridgebio.com

Who You Are:

Navire is hiring a motivated Clinical Trial Associate specializing in Trial Master File (TMF) operations to provide critical project support to our study team. The ideal candidate will have a “can-do” attitude and be open to changes that may occur last minute. You will help ensure the team’s inspection readiness by supporting the set-up, maintenance, quality control, and oversight of the TMF. In addition, you will facilitate study planning through the creation of meeting agendas and minutes, maintenance of study trackers, and assistance with reviewing clinical data.

Responsibilities:
  • Ensure Inspection Readiness by supporting the set-up, maintenance, quality control, and oversight of the Trial Master File (TMF)
  • Provide support to TMF implementation, internal audits, and regulatory inspections
  • Maintain the Trial Master File (TMF) in accordance with SOP and TMF Plan
  • Monitor and assess TMF to help ensure quality, completeness, and timeliness in the TMF for assigned studies
  • Support and conduct periodic quality reviews of the TMF to ensure timeliness, completeness, and filing accuracy
  • Support the management of TMF documentation throughout the lifecycle of an assigned study through the Manage the TMF Content List
  • Monitor TMF compliance metrics and create tools to assess the completeness and quality of the TMF (both internal and CRO/vendors)
  • Effectively communicate compliance status updates to the study team and department management, working with external vendors/CRO and study team to address gaps, issues, and rapid remediation of deficiencies
  • Participate in operational team meetings related to TMF health throughout the study lifecycle
  • Provide administrative assistance with internal and external meetings, including investigator meeting(s)
  • Assist and/or contribute to the creation and maintenance of the eTMF study plan and associated documents
  • Create and maintain study-specific metrics, and trackers
  • Review site-specific regulatory packets for completeness and accuracy
  • No matter your role at BridgeBio, successful team members are:

  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive towards practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speed


Education, Experience & Skills Requirements:
  • Bachelor's degree or equivalent training and experience (i.e., technical degree)
  • 1-3 years of related experience in clinical operations or health-related industry
  • Working experience with an eTMF and clinical trial databases/systems
  • Strong attention to detail and excellent organizational skills
  • Effective communication, interpersonal skills, and true team player
  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook
  • Ability to identify logistical problems and propose solutions 


What We Offer:
  • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
  • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
  • An unyielding commitment to always putting patients first. Learn more about how we do this here
  • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
  • A place where you own the vision – both for your program and your own career path
  • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
  • Access to learning and development resources to help you get in the best professional shape of your life
  • Robust and market competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
  • Flexible PTO
  • Rapid career advancement for strong performers
  • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
  • Partnerships with leading institutions
  • Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.