Clinical Data Manager Job at ZS
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Responsibilities
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ZS is a place where passion changes lives. As a management consulting and technology firm focused on transforming global healthcare and beyond, our most valuable asset is our people. Here you’ll work side-by-side with a powerful collective of thinkers and experts shaping solutions from start to finish. At ZS, we believe that making an impact demands a different approach; and that’s why here your ideas elevate actions, and here you’ll have the freedom to define your own path and pursue cutting-edge work. We partner collaboratively with our clients to develop products that create value and deliver company results across critical areas of their business including portfolio strategy, customer insights, research and development, operational and technology transformation, marketing strategy and many more. If you dare to think differently, join us, and find a path where your passion can change lives.
Our most valuable asset is our people.
At
ZS we honor the visible and invisible elements of our identities, personal experiences and belief systems—the ones that comprise us as individuals, shape who we are and
make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the messages they are passionate about. Learn more
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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
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Perks & Benefits:
ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member.
We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections.
Considering applying?
At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact in global healthcare and beyond. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above.
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.
To Complete Your Application:
Candidates must possess or be able to obtain work authorization for their intended country of employment.
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.
Find Out More At:
www.zs.com
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