Clinical Data Manager

EDETEK Inc.; United States; Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Vision and Dental Insurance

Paid vacation and sick days

Corporate holidays

401K Plan

Perks and discount programs

Job summary

EDETEK Inc. is seeking a Clinical Data Manager to handle project management documentation, clinical data management activities, and system implementations across eClinical platforms.

This role may be assigned work on other platforms and includes writing design specifications for systems (forms, reports, etc.) and facilitating testing of implementations. The CDM is responsible for data quality and integrity in the final locked database, and should understand Good Clinical Data Management

Qualifications

• Bachelor's degree in a scientific, medical, or technological discipline required.
• Minimum of 2 years of clinical trial or clinical data management experience required.
• Working knowledge of EDC studies and SAS required.
• Experience with the full data management life-cycle desirable.

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 to Deliver Contracted Clinical Data Management Services and 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.

Education

Bachelor's degree in a scientific, medical, or technological discipline

2 years clinical trial or clinical data management experience

Tools

EDC studies

SAS

Job 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.

Essential Functions And 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

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

Education and Experience Required

• 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.

Work Requirements

• Corporate office environment or remote.
• 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 and South America.

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.