Clinical Data Manager

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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

• The Clinical Data Manager (CDM) handles project management documentation, clinical data management activities, and system implementations for EDETEK’s eClinical, and may be assigned work on other platforms. • This includes writing design specifications for the system (forms, reports, etc.) and facilitating testing of system implementations. • The CDM is also responsible for all other traditional clinical data management operations and activities such as facilitating database audits, coding, SAE reconciliation, system and module testing, data cleaning, and locking and unlocking of clinical databases. • The CDM is responsible for translating the client’s Clinical Data Management requirements and expectations into DMP and implementing the clinical data management plans so that the clients’ expectations are met. • The CDM is responsible for the quality and integrity of the data in the final locked clinical database. • The CDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure. • Support Internal Clinical Data Management Initiatives • Complete Traditional and Assigned Data Management Operations/Activities • Contribute to Project Success by Conducting Duties per CPM/LSCDM Request • Design Case Report Forms (CRFs) • Assist in the Development and Maintenance of Systems Used to Support Project Infrastructure • Work with Clinical Data Specialists (CDSs) to Execute Data Management Plans • Work with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and Integrity • Code Data per Selected Coding Dictionaries • Clean Data • Develop / Execute Testing Strategies • Assist with Data Transfers, Loading and Integration • Complete All Required Documentation per EDETEK and Project Requirements • Perform Use Acceptance Testing (UAT) on New Software • Classify Clinical Events per Agreed-upon Strategies/Plans Classification.

🎯 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 projects6. 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.

🏖️ 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