Senior Clinical Data Management – Consultant

Job not on LinkedIn

November 12

☕ Washington – Remote

Although this job is listed in Washington, this company may be open to hiring remote in other states.

⏳ Contract/Temporary

🟠 Senior

💼 Consultant

🦅 H1B Visa Sponsor

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Outpace Bio

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Biotechnology • Artificial Intelligence • Healthcare Insurance

Outpace Bio is a biotechnology company revolutionizing cell therapy through advanced protein design. The company is focused on curing solid tumors by programming cells to make better decisions inside the body, enhancing immune responses and maximizing the potency, specificity, and safety of cell therapies. Outpace Bio uses AI-powered protein design to create new proteins and guide engineered cells in recognizing and eliminating cancer. Its platform technologies, such as OUTSMART™, OUTLAST™, and CO-LOCKR™, aim to solve the complex mechanisms that hinder effective cancer treatment. The company aspires to create curative cell therapy products that can address a wide range of cancer indications, leveraging a deep understanding of biology and technology.

51 - 200 employees

🧬 Biotechnology

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

💰 $25M Series A on 2023-03

📋 Description

• Establish the clinical DM department, initially operating as individual consultant to oversee clinical data management activities outsourced to one or more clinical CROs. • Work with cross-functional stakeholders to define the clinical data strategy. • Design and enforce a comprehensive clinical data governance framework with clear policies, procedures, and standards for data usage, security, and quality. • Define and measure clinical data quality metrics, establishing processes to continuously monitor, cleanse, and validate clinical data. • Oversee clinical data archiving and destruction as required, ensuring compliance with clinical data management standards. • Support periodic reconciliation of Translational specimen inventory across systems to confirm data integrity and sample traceability. • Design and maintain the clinical organization's overall data architecture, including databases, data warehouses, and data lakes. • Perform day-to-day clinical data management tasks such as querying, and managing clinical database performance, backups, and recovery operations. • Lead end to end clinical data management activities for clinical trials from start through database lock. • Oversee clinical database design, CRF annotation and UAT of EDC. • Partner with Translational Sciences to support clinical data from central and specialty labs: DTA generation, data ingestion, cleaning and reconciliation.

🎯 Requirements

• Educational background: Bachelor's degree • 8+ years of progressive experience in clinical data management, with a proven track record of leadership in a similar role. • Certification in clinical data management (like CCDM). • Knowledge of CRF design, MS Project or similar and analytical capabilities. • Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM). • Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). • Understanding of data privacy and protection regulations (e.g., GDPR). • Strategic and analytical mindset: Ability to translate abstract business concepts into tangible data strategies. • Exceptional communication skills: Strong written and verbal communication skills to effectively convey complex data concepts to both technical and non-technical stakeholders. • Problem-solving and adaptability: Proactive approach to identifying and solving complex data challenges, with the ability to navigate ambiguity and change. • Collaboration: Strong interpersonal skills to build relationships and collaborate effectively across diverse team