Manager, Clinical Data Management

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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EDETEK Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORM™ orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services — biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations — targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.

📋 Description

• Lead the clinical data management team. • Handle project management documentation. • Perform clinical data management activities and system implementations for EDETEK’s CONFORM eClinical. • Write design specifications for system forms, reports, and related components. • Facilitate testing of system implementations. • Oversee data management projects to ensure quality, timely delivery, and ongoing client satisfaction. • Identify client needs and develop creative project solutions using expertise, operational capabilities, and technologies. • Communicate with clients and internal teams. • Support internal clinical data management initiatives. • Complete traditional and assigned data management operations and activities. • Communicate with clients about requirements and issues, enforce standard operating procedures, and monitor project progress and timelines. • Assist in developing and maintaining systems supporting project infrastructure. • Work with Clinical Data Specialists to execute Data Management Plans. • Lead communication with clients and sponsors to deliver contracted clinical data management services with high quality and integrity. • Ensure filing of required documentation per EDETEK and project requirements. • Lead User Acceptance Testing on new software. • Select and interview clinical data manager candidates. • Train and guide junior team members.

🎯 Requirements

• Ability to communicate effectively in the English language in person, by phone and in writing. • Ability to lead functional meetings • Strong attention to detail and accuracy is a must • Excellent organizational skills • Demonstrated ability to manage multiple projects • Ability to work collaboratively, effectively, and productively in diverse organization structures. • Ability to work independently, take initiative and complete tasks to deadlines: Delivering Excellence, Serving Customers, Accountability and Ownership, Global and Cross-Functional Communication • Ability to work in a team-oriented, collaborative environment. • Ability to work positively within a continually changing environment. • Ability to effectively prioritize and execute tasks in a high-pressure environment. • Advanced computer skills and practical knowledge of MS Office and potentially project management software. • A Bachelor’s degree or equivalent combination of Education/Training/Experience is required. A degree in a scientific, medical, or technological discipline is preferred. • A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required. • Prior trial responsibility for the entire data management life-cycle is desirable. • Working knowledge of EDC studies and SAS is required. • Corporate office environment. • Some travel (5%) may be required with a potential of travel occurring over weekends. • Cross-functional interactions

🏖️ Benefits

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program