Sr. Clinical Data Manager

BridgeBio; United States; Hybrid; USD 150,000 - 185,000; Full time

Job summary

An innovative firm is seeking a Sr. Clinical Data Manager to lead data management activities for clinical studies. In this pivotal role, you will oversee data documentation, ensure data quality, and coordinate cross-functional teams. With a commitment to groundbreaking advancements in rare diseases, this role offers a unique opportunity to contribute to life-changing medicines. Join a dynamic team that values your expertise and provides a supportive environment for professional growth. Enjoy a competitive salary, comprehensive health benefits, and a hybrid work model that promotes work-life balance.

Benefits

Market leading compensation

401K with employer match

Employee stock purchase program

Referral program with cash award

Comprehensive health care

Mental health support

Unlimited flexible paid time off

Paid parental leave

Flex spending accounts

Subsidized lunch

Qualifications

• 3-5 years of data management experience in biotech or pharmaceutical settings.
• Proficient in EDC systems and data quality reviews.
• Strong understanding of ICH GCP and Good Clinical Data Management guidelines.

Responsibilities

• Leads clinical data management activities for multiple studies.
• Oversees creation and approval of data management documentation.
• Coordinates data review meetings and manages data issues.

Skills

Data management

Clinical data review

EDC systems (e.g., Medidata Rave)

Knowledge of CDISC and SDTM

Statistical analysis understanding

Interpersonal skills

Communication skills

Organizational skills

Education

Bachelor’s degree in relevant scientific discipline

Tools

Medidata Rave

MS Word

MS Excel

MS PowerPoint

Job description

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 allowsscience 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.

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

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

$150,000 - $185,000 USD

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