Clinical Trial Manager

Who You Are

The Clinical Trial Manager is responsible for the execution and management of assigned clinical studies while ensuring GCP Compliance, high study quality, and timely completion. This position is accountable for meeting functional, organizational, and corporate goals for this new product by providing successful management clinical trials.

Responsibilities

• May lead one or more clinical studies, from concept to protocol, and through the achievement of corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
• Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates and Clinical Trial Assistants
• Prepare / Review / Approve study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards, and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in the coordination of data management activities
• Coordinate study supplies
• Negotiate and manage contracts
• Review Informed Consent Forms, CRFs, and study-related materials
• Plan and participate in investigator meetings
• Assist and support the data query process
• Ensures trial master file is current and maintained

Education, Experience & Skills Requirements

• Bachelor's degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
• Prefer at least 5 years of biopharma industry experience (relevant clinical trial experience in the biotechnology, pharmaceutical, CRO, medical device industry) with at least 2 years managing clinical trials
• Must have vendor management experience in clinical operations/development
• Pediatric, orphan drug, and/or rare disease knowledge is preferred
• Strong verbal and written communication skills can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
• Ability to build and maintain strong working relationships within the department and cross-functionally to meet a project or corporate goal
• Must be able and willing to travel periodically
• Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)

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