Clinical Data Manager II

Eteraflex Connects LLC - Clinical Data Manager II

Duties: Work on development, review, and maintenance of project-specific data management (DM) documentation, including Data Management Plans (DMP), electronic Case Report Forms

(eCRF), Data Validation Plans (DVP), and External Data Transfer Agreements across the project lifecycle, ensuring compliance with protocol and sponsor requirements. Serve as the

primary DM point of contact for assigned studies, coordinating cross-functional input and aligning with study timelines and deliverables. Collaborate with relevant functional teams to design

and implement the Data Cleaning Plan; oversee and support data cleaning activities and data releases for Data Monitoring Committees (DETC/DSMB/IDMC), interim and final database

locks, and post-lock updates. Work closely with biostatistics to support dataset creation and review of Tables, Listings, and Figures (TLFs) in alignment with the Statistical Analysis Plan

(SAP). Contribute to FDA submission deliverables by reviewing clinical datasets and documentation for consistency, accuracy, and compliance with submission standards. Participate in

the planning, execution, and documentation of database User Acceptance Testing (UAT), including review and approval of test scripts and results. Conduct ongoing review and validation

of clinical data to ensure data accuracy, integrity, and completeness in accordance with study protocols and data standards. Generate and validate SAS reports for internal review and

regulatory submissions.

Requirements: Bachelor's degree or its foreign equivalent in Pharmaceutical Science, Biotechnology, Regulatory Affairs or related field + 24 months experience in any related occupation.

Skills :Experience with clinical data validation; eCRF design and review; SDTM mapping; User Acceptance Testing (UAT) of clinical databases and datasets; interpretation and application of Statistical

Analysis Plans (SAP) for creation and review of Tables, Listings, and Figures (TLFs); generation and review of SAS data listings and reports; and supporting FDA submissionready clinical datasets and

documentation.

Place of employment: 354 Turnpike St, 203B, Canton, MA 02021

Salary: $90,230/yr

Send job application to: Nehrusai Kinnera, HR Generalist, Eteraflex Connects LLC - 354 Turnpike St, 203B, Canton, MA 02021 Or email us at: ...