Clinical Data Manager

Summary

EDETEK Inc. is seeking a Clinical Data Manager to manage clinical data management documentation, operations, and system implementations for eClinical platforms and other assigned systems. The role includes designing case report forms and system specifications, executing testing and data cleaning, managing database audits and coding, supporting data transfers, and ensuring the quality and integrity of final clinical databases.

Responsibilities

• 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

Skills

• * 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 minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required
• * Working knowledge of EDC studies and SAS is required
• * Some travel (5%) may be required with a potential of travel occurring over weekends
• * A degree in a scientific, medical, or technological discipline is preferred
• * Prior trial responsibility for the entire data management life-cycle is desirable

Qualifications

Must Haves

• * 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 minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required
• * Working knowledge of EDC studies and SAS is required
• * Some travel (5%) may be required with a potential of travel occurring over weekends

Nice to Haves

• * A degree in a scientific, medical, or technological discipline is preferred
• * Prior trial responsibility for the entire data management life-cycle is desirable

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
• This is a remote position