Sr. Clinical Data Manager

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “Moneyball for biotech” approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

What You’ll Do

The Sr. Clinical Data Manager will be responsible to support all aspects of data management from study start-up to database lock including EDC design, data review/cleaning, query management, data reconciliation, data transfer specifications, and other key data deliverables as required.  The Sr. Clinical Data Manager may report to the Associate Director, Data Management or Director, Data Management.

Responsibilities

• Leads clinical data management activities for one or more clinical studies
• Oversees the creation and approval of Data Management study documentation by CROs and other vendors, to include CRFs, completion guidelines, database specifications, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans
• Understands all aspects of the study protocols and statistical analysis plans as they relate to data management deliverables and serves as a knowledgeable point person on study teams for data management activities
• Reviews 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
• Reviews 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
• Produces regular data listings for the clinical team and other functional areas
• Meets study timelines with a high degree of quality

Where You'll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.

Who You Are

• Bachelor’s degree (or equivalent) in relevant scientific discipline preferred
• Minimum of 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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing: