Manager, Clinical Data Management

Manager, Clinical Data Management leads clinical data management team to handle project management documentation, preform clinical data management activities and system implementations for EDETEK’s CONFORM eClinical, write design specifications for the system (forms, reports, etc.), and facilitate testing of system implementations. In addition to stay hands-on with clinical data management operations and activities, Manager of Clinical Data Management oversees data management projects to ensure quality, timely delivery and ongoing client satisfaction; identifies client needs and develops creative solutions for projects, leveraging expertise, operational capabilities and technologies; communicates with clients and internal teams.

The Manager, Clinical Data Management should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; 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.

ESSENTIAL FUNCTIONS

• Support internal clinical data management initiatives
• Complete traditional and assigned data management operations/activities
• Contribute to project success by communicating with clients about requirements and issues, leveraging expertise, enforcing standard operation procedures, monitoring project progress and timelines.
• Assist in the development and maintenance of systems used to support project infrastructure
• Work with Clinical Data Specialists (CDSs) to execute Data Management Plans
• Lead the communication with clients/sponsors as necessary to deliver contracted clinical data management services and clinical data with high quality and integrity
• Ensure filing of all required documentation per EDETEK and project requirements
• Lead Use Acceptance Testing (UAT) 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

Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.

• 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

Location

This is a remote position, and we are open to candidates based in the United States.

Equal Opportunity Employer Statement

EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.