(Senior) Clinical Trial Associate - TMF

Full-TimeNavireSan Francisco, CAClinical Operations

Apply Now

Navire Pharma, a subsidiary 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.
 
To learn more, 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.
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 enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.
careers

(Senior) Clinical Trial Associate - TMF

Full-TimeNavireSan Francisco, CAClinical Operations

Apply Now