Sr. Manager/Associate Director of Clinical Data Management

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Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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 eidostx.com/ www.bridgebio.com

Location

San Francisco, CA

Who You Are

The Sr. Manager/Associate Director of Clinical Data Management is responsible for overseeing Data Management operational activities through all study phases for the program or studies assigned. The role includes supporting the design, development, validation, implementation, maintenance, and close-out of clinical study databases for all clinical studies. The Sr. Manager/ Associate Director of Clinical Data Management will ensure a high quality of deliverables from within Data Management and Data Management vendors.

Responsibilities

  • Interfaces with study team, vendors, and sites to ensure that data management activities are performed consistently and deliverables are of high-quality
  • Represents Data Management in study team meetings and facilitates cross-functional activities (e.g., clinical data listing reviews, database lock activities, etc.)
  • Oversees and performs ongoing data review activities, including identification, tracking, and resolution of data issues
  • Ensures data management timelines and deliverables, including metric output, are detailed and communicated to the study team regularly
  • Provides oversight of external data providers and corresponding data reconciliation (e.g., IRT, safety, central and specialty labs, the patient-reported outcomes, etc.)
  • Provides oversight of data transfers and documentation of Data Transfer Plans for study
  • Authors, reviews, and/or approves various study-related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures records are maintained throughout the study
  • Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)
  • Coordinates and/or provides training on data management systems, reporting tools, etc.
  • Contributes to preparation, conduct, and follow-up on Investigator Meetings
  • Participates in vendor selection and contract negotiation process, including RFPs and bid defense meetings, as applicable
  • Participates in the development and maintains a working knowledge of study protocols and any amendments
  • Participates as subject matter expert during regulatory inspections and/or vendor audits
  • Contributes to the development of Data Management SOPs and Working Instructions, in addition to cross-functional SOPs, as applicable
  • Ensures adherence to ICH GCP Guidelines and Good Clinical Data Management Practices

Education, Experience & Skills Requirements

  • Minimum of 8 years of Data Management experience in the pharmaceutical and/or biotech space, as a lead role, and/or management experience a plus
  • Bachelor’s degree or equivalent
  • Working knowledge of GCP ICH and GCDMP guidelines and the clinical development process
  • Experience as Data Management Lead in all phases of clinical trials
  • Experience managing vendors, including performance assessments
  • Previous experience working with an Electronic Data Capture system (EDC)
  • Proficient with MS Word, Excel, and PowerPoint
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Demonstrated ability to work independently, as well as part of a multi-functional study team
  • Ability to motivate a team to work effectively in a changing environment
  • Ability to multi-task, prioritize and solve problems

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
careers

Sr. Manager/Associate Director of Clinical Data Management

Apply Now