Manager, Data Management – Contract

This is a fully remote position, open to applicants in California.

📋 Description

• Supervise data management tasks for clinical and pharmaceutical trials across all phases.

• Work in partnership with clinical and pharmaceutical study teams to ensure that deliverables, timelines, and data are collected, managed, and reported clearly, accurately, and securely.

• Act as the primary liaison between Data Management and clinical study teams for assigned studies.

• Coordinate with Medical, Clinical Operations, Project Management, Biostatistics, Quality Assurance, Regulatory Affairs, and external vendors.

• Oversee CRO data management activities and deliverables, including setting priorities, project plans, scopes, and managing changes.

• Serve as a subject matter expert in Data Management from protocol review to database lock.

• Ensure project deliverables are met and propose solutions for any data management challenges.

• Develop and implement Data Management project plans that encompass timelines, milestones, quality control, database setup, study conduct, and closeout activities.

• Guarantee the quality of deliverables from Data Management vendors in accordance with Zentalis standards.

• Manage vendor performance and quality, escalating issues when necessary.

• Provide updates on project status and vendor performance concerning quality and timelines.

• Formulate risk mitigation and action plans as needed.

• Engage in the review of protocols and other study-related documentation.

• Ensure adherence to Data Management standards and SOPs.

• Manage complex trials and partnerships.

• Function as a Data Management consultant for special initiatives.

• Execute other assigned tasks.

⛳️ Requirements

• BA/BS or MS with 4-8+ years of experience in the Data Management domain.

• Experience in managing CROs and Data Management vendors is essential.

• Preference for experience in a global/cross-cultural environment.

• Comprehensive understanding of the drug development process and data management procedures.

• Familiarity with pertinent Pharma Industry guidelines and Best Practices.

• Knowledge of GCP, CFR 21, and other relevant regulations.

• Awareness of current global regulatory guidelines applicable to Clinical Data Management.

• Proficiency with Electronic Data Capture tools.

• Skills in MS Word, MS Excel, and MS Project.

• Understanding of Coding.

• Exceptional oral and written communication, as well as presentation skills.

• Capability to handle multiple studies and processes simultaneously under tight deadlines.

• Demonstrated ability to develop relationships and manage expectations with CROs and cross-functional clinical teams.

• Strong internal customer management, peer influence, team effectiveness, timeline management, proactive problem-solving, trust-building, and alignment on shared goals and values.

• Collaborative mindset, accountability for deliverable milestones, and conflict resolution skills.

• Negotiation and problem-solving capabilities.

• Detail-oriented with a knack for timely issue identification and resolution.

• Ability to work independently with minimal supervision in a fast-paced setting.

• Experience with oncology studies is advantageous.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and advancement.

• Flexible work schedules and remote work options.

• Supportive and inclusive company culture.