Clinical Data Manager

EDETEK Inc. is hiring a Clinical Data Manager to manage clinical data activities and eClinical system implementations. The role translates client requirements into data management plans and oversees data quality and integrity throughout the clinical database lifecycle.

Responsibilities

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

Preferred

A degree in a scientific, medical, or technological discipline is preferred

Prior trial responsibility for the entire data management life-cycle is desirable

technology degree

Clinical trial data management lifecycle

Benefits

Choice of comprehensive Medical, Vision and Dental Insurance plans for U.S. employees

Paid vacation time and sick days for U.S. employees

Corporate holidays annually for U.S. employees

Participation in the 401K Plan for U.S. employees

Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. for U.S. employees

Health Advocate and Employee Assistance Program for U.S. employees

Remote position

Company

Clinical technology platforms and services for life sciences

Princeton, New Jersey, USA

https://www.edetek.com/

Founded in 2009

201-500 employees

Qualifications

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 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

A degree in a scientific, medical, or technological discipline is preferred

Prior trial responsibility for the entire data management life-cycle is desirable

A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required.

Required skills

Clinical Data Management, Clinical Trials, EDC Studies, SAS, MS Office, Meeting Leadership

Experience

2+ years