Clinical Data Acquisition Tech Lead

4 weeks ago

Mississauga, Canada AstraZeneca Full time

**About the role**
- As a Clinical Data Acquisition Tech Lead, you will be key member of the Clinical Development Platform capability IT team which will be core product technologies managing Clinical eSource technologies and solutions such as EHR, eCOA/ePRO, Labs built on products such as EDC, Clinical Data Review & Monitoring/Visualization landscape to ensure data is capture, transform, and publish in adherence to CDISC standards and risk-based study monitoring approach.
- In this role one will have the opportunity to collaborate with Business Platform Manager, Product Manager/Owner, IT Platform Engineers, DevOps Lead, and Solution/Integration Architects within AZ to establish best practices for software development and engineering, business analysis, solution designs, enterprise software integration and project management in line with BizDevOps IT Platform Delivery Model.

**Responsibilities**:

- Lead and provide strategic insights into protocol development, specifically focusing on external data collection and integration.
- Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
- Ensure that data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting.
- Develop detailed data transfer specifications for acquiring external data from third-party vendors.
- Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
- Oversee Data Management Contract Research Organizations (DM CROs) for seamless external data transfers.
- Review and assess vendor contracts, setup specifications, and test data transfers.
- Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle.
- Serve as Technical Subject Matter Expert (SME) for Clinical Data acquisition solutions through the implementation process and life cycle of the study by providing guidance to the partner/sponsor and internal teams on the design and support of Clinical Data Products.
- Create technical backlogs/Story/Epic in JIRA (as appropriate) and ensure IT delivery based on the product delivery roadmap priority in Agile WoWs.

**Essential Skills/Experience Required**:

- Bachelor/master’s degree in IT or life science related discipline with IT/CRO/Pharma experience.
- Excellent understanding of common industry standard business practices as related to clinical trials (study set up, clinical operations, data management and reporting).
- Working knowledge of CDASH, SDTM, and CDISC controlled Terminology in context of clinical data and FHIR Electronic Health Records.
- Strong knowledge of ICH guidelines, 21 CFR Part 11, clinical trial methodology and software development lifecycle activities.
- Expertise and/or experience in specialized analysis and reporting standards development skills (e.g., clinical coding, clinical dictionaries, and data analysis & reporting capabilities.
- Experience with external vendors and CROs to support Standards or EDC integrations with third party platform (Central Lab, ePRO, IRT, Data Review/Monitoring, etc.)
- Strong understanding of clinical trial processes and regulations, with knowledge of industry standards such as CDISC (Clinical Data Interchange Standards Consortium).
- Strong understanding of clinical trial processes and regulations, with knowledge of industry standards such as CDISC (Clinical Data Interchange Standards Consortium).
- Proven track record of successfully implementing eSource technologies, such as Electronic Data Capture (EDC) systems, IXRS, electronic Clinical Outcome Assessment (eCOA) platform, and electronic Patient-Reported Outcome (ePRO) solutions.
- Proficiency in programming languages (e.g., SQL, Python) and/or familiarity with data modelling and analysis tools.
- Excellent communication skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
- Strong collaborative skills, with a demonstrated capability to lead cross-functional teams and drive projects to successful completion.

**Preferred Qualifications**:

- Accredited Certifications from SCDM/ACDM or any vendor offered data management trainings.
- Experience with cloud-based platforms (e.g., Veeva, Salesforce, Oracle Clinical, AWS, Azure) and knowledge of security best practices in healthcare IT environments.
- EDC build (Rave)/Inform and global library maintenance support experience a plus.
- Extensive Experience in clinical data management, clinical data analytics and visualization. clinical data programming experience is a plus.

**WHY JOIN US?**

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always

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