Clinical Data Manager job in Boston, USA

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Last Name*

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), CRA Manager, Project/Study Manager (CSM/CPM)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Clinical Data Manager with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings.
Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.
Responsible for the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials.
Provide ongoing operational support for Medidata RAVE activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications.
Provide ad-hoc report development, and support database lock and archiving activities.
Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies where protocol requirements are outside of standard CRF library versions.
Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
Provide guidance to clinical data management personnel on assigned projects, reviewing study documents as needed, e.g. Data Management Plan, Operational Plan for database locks
Ensure project documentation is being archived in a timely manner into the Trial Master File.

Skills and Requirements:

Experience in clinical data management for 7+years

Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
Medidata Rave experience required.
Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-BC1

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