Manager, Data Management – Contract

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $50 - $80 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

📊 Data Scientist

👻 Ghost score 0%

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Zentalis Pharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $25M Post-IPO Equity on 2022-04

Biotechnology • Pharmaceuticals • Healthcare

Zentalis Pharmaceuticals is developing potentially best-in-class, novel small molecules that target fundamental biological pathways in cancer. The company focuses on creating therapeutics aimed at treating various forms of cancer by leveraging innovative approaches in biotechnology.

📋 Description

• Oversee data management activities for clinical and pharmaceutical trials across all phases • Collaborate with clinical and pharmaceutical study teams to ensure deliverables, timelines, and data are collected, managed, and reported clearly, accurately, and securely • Serve as the primary contact between Data Management and clinical study teams for assigned studies • Liaise with Medical, Clinical Operations, Project Management, Biostatistics, Quality Assurance, Regulatory Affairs, and external vendors • Manage CRO data management activities and deliverables, including priorities, project plans, scopes, and changes • Serve as a Data Management subject matter expert from protocol review through database lock • Ensure project deliverables and propose solutions for data management issues • Develop and execute Data Management project plans covering timelines, milestones, quality control, database setup, study conduct, and closeout • Ensure the quality of deliverables from Data Management vendors according to Zentalis standards • Manage vendor performance and quality; escalate issues when necessary • Communicate project status and vendor performance regarding quality and timelines • Develop risk mitigation and action plans where appropriate • Participate in reviewing protocols and other study-related documents • Ensure Data Management standards and SOPs are followed • Manage complex trials and partnerships • Act as a Data Management consultant on special initiatives • Perform other assigned duties

🎯 Requirements

• BA/BS or MS and 4-8+ years of experience in the Data Management field • Experience managing CROs and Data Management vendors required • Working in a global/cross-cultural setting preferred • In-depth knowledge of the drug development process and data management process • Awareness of related Pharma Industry guidelines and Best Practices • Knowledge of GCP, CFR 21, and other regulations • Awareness of current global regulatory guidelines relevant to Clinical Data Management • Familiarity with Electronic Data Capture tools • MS Word, MS Excel, and MS Project skills • Knowledge of Coding • Excellent oral, written communication, and presentation skills • Ability to manage multiple studies and processes simultaneously under tight timelines • Proven ability to build relationships and manage expectations with CROs and multifunctional clinical teams • Internal customer management, peer influence, team effectiveness, timeline management, proactive problem-solving, trust-building, shared goals, and values • Collaborative thinking, accountability for deliverable milestones, and conflict resolution • Negotiation and problem-solving skills • Detail-oriented with timely issue identification and problem-solving • Ability to work independently with minimal supervision in a fast-paced environment • Oncology study experience is a plus