Job title: Clinical Data Manager II – Remote
Company: Orbis Clinical
Job description: The Clinical Data Manager II (CDM II) is responsible for Data Management activities across multiple studies. CDM II will report to the Manager/Sr. Manager, Clinical Data Management, and will work closely with a cross-functional team in a fast-paced environment. The CDM II is responsible for coordinating and supporting data management activities in the design, conduct, data collection, and lock of databases for clinical trials. As part of the Clinical Team, the CDM II will play a key role in the maintenance of clinical studies and will be expected to interface with the internal team, sponsors, and external vendors to fulfill many of his/her responsibilities.RESPONSIBILITIESThis is a direct, hands-on role and the primary responsibility is to perform day-to-day Data Management activities. These responsibilities include, but are not limited to:
- Perform Data Management activities and support to internal and external project teams.
- Perform data cleaning activities including the development, review, and generation of queries and query tracking.
- Create study documentation Data Management Plan (DMP), Data Review Plan (DRP), Data Transfer Agreements (DTA), User Acceptance Testing Plan (UAT), Case Report Form (CRF) Completion Guidelines (CCGs), and other plans as required.
- Organizing and conducting scheduled cross-functional data review, 3rd party data reconciliation, and the identification of data issues and tracking through to resolution.
- Conduct database build activities in addition to database validation and review.
- Create required UAT documentation and execute User Acceptance Testing of assigned clinical databases.
- Participate in the design of Electronic Case Report Forms (eCRF)/ CRF, development of
- Edit Check Specifications, CCGs, and electronic Data Handling Conventions.
- Work with external vendors (such as safety laboratories, cardiac laboratories,
- Interactive Response Technology (IRT) and/or electrocardiogram(ECG) system providers, ePRO/electronic diary providers) to develop data transfer documents and perform data reconciliation between the 3rd party data and the clinical database.
- Create and deliver Data Management study metrics, in addition to actively reviewing and providing feedback on study data quality.
- Forecast hours available against study activities.
- Assess if the study activities are in scope per the approved budget report any out-of-scope changes to the Sr. CDM.
- Enter and verify the time spent on project and non-project work on the time tracking tool regularly (daily time entries preferred, weekly at the minimum required).
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $55 – $65 per hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.Additional skills : Candidate with LI profiles are prioritized. Please send with submittals.
Expected salary: $55 – 65 per hour
Location: Woburn, MA
Job date: Sun, 09 Feb 2025 01:56:29 GMT
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