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 together 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 disease, 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.

What You'll Do

The Associate Director, Clinical Data Management will be responsible for leading and executing the Data Management operational activities through all study phases for program or studies assigned. This includes supporting the design, development, validation, implementation, maintenance and close-out of clinical study databases for all clinical studies. The Associate Director, Clinical Data Management will ensure a high level of quality for deliverables from within Data Management and from 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 as the DM lead or DM point of contact for study
• Performs and/or Coordinates the ongoing data review activities, including identification, tracking and resolution of data issues
• Leads data management timelines and deliverables, including metric output, are detailed and communicated to the study team on a regular basis
• Participates in the oversight of external data reconciliation (e.g., IxRS, safety, central and specialty labs, patient reported outcomes, etc.)
• Participates in the oversight of data transfers and review/approval of 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 documents are maintained throughout the duration of the study
• Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)
• Coordinates the clinical data review listings, reporting of metrics, and adhoc requests · Contributes to the conduct of clinical data review and preparation for DMC, DSUR, Database Freeze, Database Lock and/or other data deliverables
• Participates in vendor selection, including RFPs and bid defense meetings, as applicable · Maintains a working knowledge of study protocols and any amendments

Where You'll Work

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

Who You Are

• Minimum of 8 years of Data Management experience in the pharmaceutical and/or biotech space, as a lead role
• Bachelor’s degree or equivalent
• Experience with mentoring or supervising junior staff
• Experience working with a CRO and/or mentoring/supervising junior staff
• Experience as Data Management Lead in all phases of clinical trials
• Experience with external vendor oversight
• Previous experience working with an Electronic Data Capture system (EDC)
• Proficient with MS Word, Excel and PowerPoint

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

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