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Senior Clinical Trial Manager


QED Therapeutics

Brisbane, CA

Posted June 17

Job Description


With singular focus, QED is devoted to the development of our investigational candidate, infigratinib. A first-in-class, selective, tyrosine kinase inhibitor, infigratinib has promising early clinical data in patients with previously treated, FGFR-driven cholangiocarcinoma and metastatic urothelial carcinoma, as well as preclinical studies in achondroplasia. Future studies will investigate infigratinib for additional FGFR-driven tumor types and rare disorders. 

FGFR=fibroblast growth factor receptor.
 
To learn more, visit us at  https://www.qedtx.com/ | https://bridgebio.com 
 

Who You Are:

The Senior Clinical Trial Manager (Sr. CTM) is responsible for managing operational activities of assigned clinical programs. This individual role provides a level of expertise, aligned with the principles and standard practices for operational activities of clinical trials QED Therapeutics. Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO oversight, training, vendor management and review of agreements related to CRO clinical activities. Partner with key stakeholders - internal and external - to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for functioning in a cross-functional environment.  Global trial experience a plus.
 

Responsibilities:

    • Responsible for representing Clinical Operations (ClinOps) on cross-functional study teams and Vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
    • Provides leadership for ClinOps related issues and advise management team of potential issues and solutions
    • Responsible for the review and oversight of tasks in study monitoring plans for operations and all operational activities associated with clinical trials
    • Responsible for ensuring that all components of the trial master file (TMF/eTMF) are up to date and accurate for QED assigned investigational trials
    • Monitors global regulatory intelligence for global industry practices for operational efficiency and compliance
    • Responsible for operational guidance for investigators and provide CRO training related to the study conduct
    • Responsible for reviewing study budgets and master ICF templates for study start-up
    • Responsible for managing queries for clinical studies from CROs and address issues raised by CROs or other service providers
    • Participates in the conduct of audits and support regulatory inspections related to GCP
    • Addresses consistency in the collection, processing, and evaluation of clinical data
    • Contributes to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements
    • Represents Clinical Operations on cross-functional teams
    • Supports QED sponsored clinical trials and development programs

Education, Experience & Skills Requirements:

    • Bachelor’s required in a scientific/medical field; advanced degree preferred
    • Minimum 8 years of experience in Clinical Operations, working with CROs and other vendors
    • At least 5 years of management experience in a clinical research environment
    • Previous experience working in a cross-functional environmentHistory of successfully developing effective relationships with outside vendors and CROs
    • Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
    • Demonstrated skills in negotiation, multi-tasking, organization and decision making
    • Proficiency in databases, coding and data mining methodologies we well as Microsoft applications
    • Ability to travel to regional and global sites
    • Prior experience working in a start-up environment is a plus

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


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