Senior Clinical Data Manager

Full-TimeEidosSan Francisco, CABiostatistics & 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

Who You Are:

The Senior Clinical Data Manager will be responsible for supporting all aspects of data management from study start-up to database lock, including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications
Responsibilities:
  • Lead all clinical data management activities for one or more clinical studies
  • Oversee the creation and approval of Data Management study documentation by CROs and other vendors, including CRFs, completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans
  • Understand all aspects of the study protocols and statistical analysis plans related to data management deliverables and serves as a knowledgeable point person on study teams for data management activities
  • Review clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites, and potential risks to timelines
  • Review the deliverables of data management vendors to ensure accuracy and consistency with expected practices
  • Coordinate cross-functional data review meetings with the clinical team; manage the collection of data issues, reporting of findings, and communication of post-review status
  • Produce regular data listings for the clinical team and other functional areas
  • Meet study timelines with a high degree of quality
Education, Experience & Skills Requirements:
  • Bachelor’s degree (or equivalent) in relevant scientific discipline preferred.
  • Minimum 3 - 5 years of data management experience in the biotech, pharmaceutical, and/or CRO setting; as well as experience with global studies
  • Skills present in core data management activities (e.g., data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews, and reporting)
  • Knowledge of CDISC and SDTM standard terminology
  • Knowledge of ICH GCP and Good Clinical Data Management guidelines
  • Experience working with an Electronic Data Capture system (EDC) (e.g., Medidata Rave) and with other databases (e.g., Central Imaging, IVRS/IWRS)
  • 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
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 Data Manager

Full-TimeEidosSan Francisco, CABiostatistics & Data Management

Apply Now