Clinical Data Manager jobs in Weymouth, MA

• Advanced programming capacity and data visualization using standard data science tools (such as R or python, SAS, SPSS), and data visualization tools.
• Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting.
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review.
• Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
• Minimum 5 years Data Management experience required.
• Strong Project and Risk Management.
• Strong verbal and written communication skills.
• A proven track record of being a detail-oriented, motivated, self-starter, strategic with time management and organizational skills.
• Candidates must possess work authorization for their intended country of employment.
• Must have received or be .willing to receive the COVID-19 vaccination by date of hire to be considered
• Proof of vaccination will be required.

Requirements:

• As part of the Evidence Generation and Outcomes Research (EGOR) team, the Clinical Data Manager (CDM) is responsible for timely and high-quality data management deliverables supporting the EGOR.
• The CDM delivers asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization.
• The CDM designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, applies standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data.
• Serve as Clinical Data Manager for one or more clinical trials assuming responsibility for all DM&M activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
• Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools.
• Serve as a technical resource to the study teams and clients for DM and RBM standards, tools, data provisioning, and reporting.
• Partners with internal ZS and external service provider to deliver high quality data management for all studies as assigned.
• Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s).
• Ensure work carried out by DM providers is in accordance with applicable SOPs and working practices.
• Ensure the required study-specific DM&M documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
• Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.