Associate Director, Clinical Data Management

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

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

The Associate Director, Clinical Data Management 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, and data transfer specifications.

Responsibilities

•  Leads all 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, 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 as they relate to data management deliverables and serve 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
• Review the deliverables of data management vendors to ensure accuracy and consistency with expected practices
• Coordinates 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 

Who You Are

• Bachelor’s degree (or equivalent) in relevant scientific discipline preferred
• Minimum of 7 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, editing 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 multifunctional 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:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities