Offer summary

Qualifications:

10+ years of experience in pharmaceutical clinical data management, Minimum of 5 years working for a CRO company, Experience interfacing with sponsors and external vendors, Strong understanding of data management processes and clinical trial operations..

Key responsabilities:

Coordinate and support data management activities for clinical trials

Perform data cleaning and generate queries for data quality assurance

Create and manage study documentation such as Data Management Plans and User Acceptance Testing Plans

Conduct database validation and collaborate with external vendors for data reconciliation.

Job description

SRG, the leader in the Life Sciences human capital industry, is looking for a full-time, contract Clinical Data Manager II to join our client's pharmaceutical team. 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. This is a fully remote position.

*THIS POSITION IS FOR A W2 CONTRACT ONLY, we cannot accept C2C.

MUST HAVES:

10+ years' experience in pharmaceutical clinical data management
Previously worked for a CRO company (minimum of 5 years) *please indicate this on your resume
Experience interfacing with sponsors and external vendors

JOB RESPONSIBILITIES:

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.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.

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