Clinical Data Acquisition Tech Lead

7 months 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

  • AI Solutions Architect, Clinical Data Integration

    4 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

    Roche is seeking a talented technical expert with in-depth AI experience and biomarker data expertise to drive technical directions and ensure strong business impacts.About the RoleThis is an exciting opportunity to join our team as an AI Solutions Architect, Clinical Data Integration. As a key member of our Data Curation and Integration (DCI) Enabling...

  • Talent Acquisition Lead

    3 days ago

    Mississauga, Canada Myant Full time

    **About Us** At Myant, we are creating the world’s first expressive and continuous digital presence platform, enabled by integrating technology directly into clothing and augmented by other devices, wearables, and IOT. We see the evolution of society where every member gets to participate from anywhere and anytime through a whole-body experience, mostly...

  • AWS Tech Lead

    4 weeks ago

    Mississauga, Canada United Software Group Inc. - Canada Full time

    Hi, Greetings! Hope you are doing great. My name is Pradeep Chauhan and I am a Senior Technical Recruiter in United Software Group INC., an Ohio-based fast-growing multi-national IT & Engineering Consulting Company, serving its clients for the last 20 years with a staff strength of 2500 in 17 offices globally, operating across 8 countries in North America,...

  • Web Development Tech Lead

    4 days ago

    Mississauga, Canada Tekskills Inc Full time

    Hi, **Job title : Web Development Tech Lead** **Location : Mississauga, ON (Initially Remote)** **Duration : 12 Months** - Web Tech Lead will provide technical expertise to support the Patient 360 Data Access product and Design studio team. - This position focuses on the continuing evolution, implementation, and support of existing and new vendor-based...

  • Web Development Tech Lead

    4 days ago

    Mississauga, Canada Tekskills Inc Full time

    **Job title : Web Development Tech Lead** **Location : Mississauga, ON (Initially Remote)** **Duration : 12 Months** - Web Tech Lead will provide technical expertise to support the Patient 360 Data Access product and Design studio team. - This position focuses on the continuing evolution, implementation, and support of existing and new vendor-based systems...

  • Executive Leadership Position for Cloud Tech

    3 weeks ago

    Mississauga, Ontario, Canada CLOUD TECH Full time

    Job Title: Executive Leadership Position for Cloud TechWe are seeking a highly skilled and experienced Executive Leader to join our team at Cloud Tech. This is a senior leadership role that requires strategic thinking, exceptional communication skills, and the ability to motivate and inspire a high-performing team.About UsCLOUD TECH is a leading provider of...

  • Divestments Acquisitions

    4 months ago

    Mississauga, Canada AstraZeneca Full time

    **Introduction to role**: The** Director, Divestments, Acquisitions & Collaborations (DAC) **will work with the Senior Director DAC and Business Development Groups to understand any potential divestments, acquisitions and collaborations that may impact clinical teams across Biopharma and Oncology. They will work with the clinical teams to support the...

  • Senior Data Scientist

    3 weeks ago

    Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full time

    Lead a Team of ExpertsWe are seeking an exceptional Senior Data Scientist with expertise in AI and biomarkers to drive technical directions and ensure strong business impacts for our Data Curation and Integration Enabling Platform.This role offers the opportunity to design, develop, implement, and deliver high-quality data integration solutions for complex...

  • Cloud Engineering Lead

    2 weeks ago

    Mississauga, Ontario, Canada NexGen Tech Solutions Full time

    Job Title: Cloud Engineering LeadAbout Us: NexGen Tech Solutions is a forward-thinking company that utilizes cutting-edge technologies to deliver innovative solutions.Salary: $150,000 - $180,000 per yearJob Description: As a Cloud Engineering Lead at NexGen Tech Solutions, you will play a pivotal role in designing, developing, and maintaining our data...

  • Director, Clinical Data Management

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **Director Clinical Data Management** **Hybrid work (3days from the office, 2 days from home)** The role holder will be responsible for developing the Clinical Data Management (CDM) strategy for either the therapeutic area/indication and/or strategic roles at DM organisation level. Will be responsible for CDM quality, management of external partners,...

  • Director - Clinical Data Management

    6 months ago

    Mississauga, Canada AstraZeneca Full time

    **Job Title: Director - Clinical Data Management** **Career Level - F** **Introduction to role**: Join us at AstraZeneca as a Director of Clinical Data Management, where you will be responsible for developing the Clinical Data Management (CDM) strategy for either the therapeutic area/indication and/or strategic roles at DM organisation level. You will be a...

  • Associate Director External Data Strategy

    7 months ago

    Mississauga, Canada AstraZeneca Full time

    **About the role**: As an Associate Director, External Data Strategy, within our Rare Disease Clinical Data & Insights (rCDI) division, your responsibilities will revolve around leading, contributing and implementing rCDI strategies. You'll be responsible for leading the development and execution of comprehensive strategies for the acquisition, management,...

  • Proposal Lead

    3 days ago

    Mississauga, Canada Tetra Tech Full time

    Discover your full potential. At Tetra Tech, we are collaborating with industry-leading experts for a sustainable future for our world. We combine consulting and engineering with advanced analytics and technology to solve the world’s most complex challenges. Our innovation hubs across the globe will enable you to share ideas and best practices while...

  • Coding and Data Quality Lead

    4 weeks ago

    Mississauga, Canada AstraZeneca GmbH Full time

    p>This is what you will do:• As a Principal Clinical Data Lead in our Clinical Data Management (CDM) division, you are responsible for independently ensuring the accuracy and timely delivery of clinical data for highly complex studies. Your role extends beyond technical expertise as you'll serve as a positive role model for peers, encouraging both...

  • Senior Cloud Data Architect

    4 weeks ago

    Mississauga, Ontario, Canada NexGen Tech Solutions Full time

    NexGen Tech Solutions is seeking a highly skilled Azure Data Solutions Engineer to join our team. In this role, you will design and implement scalable, reliable, and high-performance data architectures on the Azure cloud platform.About the JobThis position offers a competitive salary of $140,000 - $180,000 per year, depending on...

  • Data Entry Specialist

    7 months ago

    Mississauga, Canada BoomerangFX Full time

    **Why BoomerangFX?** BoomerangFX is more than just a SaaS tech company - we are one of North America’s fastest-growing healthcare SaaS solutions providers offering integrated practice management software, digital marketing and e-learning solutions to the aesthetic medical industry - we serve specialized industry segments spanning dermatology, medspa,...

  • Clinical IT Business Analyst

    8 months ago

    Mississauga, Canada AstraZeneca Full time

    **Clinical IT Business Analyst** **Gothenburg (Sweden) Warsaw (Poland) Mississauga (Canada)** **Job Role** Leverage technology to impact patients and ultimately save lives! Are you an experienced Business Analyst motivated by using technology to drive change? Then this job might be what you are looking for! **About AstraZeneca** AstraZeneca is a global,...

  • Coding and Data Quality Lead

    4 weeks ago

    Mississauga, Canada AstraZeneca GmbH Full time

    p>This is what you will do:• As Senior Clinical Data Lead within our Clinical Data Management (CDM) division, you are responsible for independently ensuring the accuracy and timely delivery of clinical data for both study and non-study projects. Your role involves performing various tasks to guarantee the accuracy, completeness, and compliance of data...

  • Coding and Data Quality Lead

    4 weeks ago

    Mississauga, Canada AstraZeneca GmbH Full time

    This is what you will do:As Senior Clinical Data Lead within our Clinical Data Management (CDM) division, you are responsible for independently ensuring the accuracy and timely delivery of clinical data for both study and non-study projects. You will also contribute to the development of new concepts, technologies, and standards. Your role involves...

  • Lead Data Engineer

    22 hours ago

    Mississauga, Canada NexGen Tech Solutions Full time

    Position: Lead Data EngineerJob Type: Full Time Contract Location: Mississauga, ON (Hybrid)Must Have: Azure DevOps , ADF, SSIS, Databricks, SQL Must HaveAs our new Data Engineer, you will play a role in designing, developing, and maintaining our data architecture on the Azure platform. You can expect to collaborate with cross-functional teams, leverageyour...