Manager, Clinical Data Management

Job 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