Clinical Data Manager
Z's Associates, Inc

Job Info

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ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people-a fact that's reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated. ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond.

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.

Responsibilities

• 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.

Qualifications

• 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
• CRO and vendor oversight experience preferred
• 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

ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable.

Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.

ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.

ZS is committed to providing and maintaining a safe workplace. Must have received full COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required upon acceptance of offer of employment. Exemption process available on a limited basis.

NO AGENCY CALLS, PLEASE.

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