Clinical Data Acquisition Tech Lead

7 days ago


Mississauga, Ontario, 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 riskbased 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 thirdparty 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 crossfunctional teams and drive projects to successful completion.

Preferred Qualifications:

  • Accredited Certifications from SCDM/ACDM or any vendor offered data management trainings.
  • Experience with cloudbased 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

  • Mississauga, Ontario, Canada AstraZeneca Full time

    About the role The role of our ideal candidate will include but not limited to: 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,...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being daring, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.As a Clinical Data IT Product...


  • Mississauga, Ontario, Canada BoomerangFX Full time

    Job descriptionWhy BoomerangFX?BoomerangFX is more than just a SaaS tech company - we are one of North America's fastest-growing healthcare 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,...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    Job Title: Director - Clinical Data ManagementCareer Level: FRole Overview:Join our team at AstraZeneca as a Director of Clinical Data Management, where you'll lead the development of the Clinical Data Management (CDM) strategy for specified areas within the organization. This role is crucial within our Oncology R&D team, ensuring CDM quality, managing...


  • Mississauga, Ontario, Canada BoomerangFX Full time

    Job descriptionWhy BoomerangFX?BoomerangFX is more than just a SaaS tech company - we are one of North America's fastest-growing healthcare 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,...

  • Tech Lead

    7 days ago


    Mississauga, Ontario, Canada Epsilon Solutions Ltd. Full time

    Role - Tech LeadLocation: Anywhere in Canada|-RemoteTime Zone: Working hours in CST/ESTExperience: 10+ years JD:As a Senior Software Development Engineer in the Data & Services Technologies team, you will play a valuable role within a successful and rapidly growing business unit, working closely with experienced and motivated engineers to solve challenging...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    This is what you will do: A Principal Clinical Data Manager (PCDM) has keen attention to detail and is responsible for overseeing the startup and execution of several trials with a CRO or inhouse to ensure data quality and integrity. PCDMs will independently lead multiple, high volume, and extremely complex studies within a development program. The...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    Director Clinical Data ManagementHybrid 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, internal...


  • Mississauga, Ontario, Canada GSK Full time

    Site Name: Canada - Ontario - MississaugaPosted Date: Apr As Clinical Data Manager you will be responsible for overseeing the end-to-end DM study related activities and is accountable for all Data Strategy & Management (DS&M) study deliverables in terms of quality & delivery to plan.This role will provide YOU the opportunity to lead key activities to...


  • Mississauga, Ontario, 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, and...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    Clinical IT Business AnalystGothenburg (Sweden) Warsaw (Poland) Mississauga (Canada)Job RoleLeverage 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 forAbout AstraZenecaAstraZeneca is a global, innovation-driven...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in...


  • Mississauga, Ontario, Canada Tetra Tech Full time

    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 growing your professional network....


  • Mississauga, Ontario, Canada AstraZeneca Full time

    When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the...


  • Mississauga, Ontario, Canada GSK Full time

    Site Name: Canada - Ontario - MississaugaPosted Date: Apr Are you an enthusiast Data Management Expert looking into Project Management experience? If so, this Asset Data Management Quality Lead opportunity could be an exciting opportunity to consider.Job Purpose As Asset Lead Data Management Quality Lead you will be responsible for overseeing the endtoend...


  • Mississauga, Ontario, Canada Myant Inc Full time

    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. Humans have a fundamental desire and need to be connected to our environment, family, community, and technology. This level of connection will create a...


  • Mississauga, Ontario, Canada GSK Full time

    Site Name: Canada - Ontario - Mississauga, Collegeville TSA, GSK House, Stevenage, WarsawPosted Date: May Please Note: We have multiple positions available in Canada (Mississauga, Ontario), USA (Collegeville, PA), UK (Stevenage and GSK House) & Poland (Warsaw).Would you like to be part of GSK's clinical development team, with an opportunity to drive and lead...


  • Mississauga, Ontario, Canada Myant Inc Full time

    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. Humans have a fundamental desire and need to be connected to our environment, family, community, and technology. This level of connection will create a...

  • Data Science Expert

    7 days ago


    Mississauga, Ontario, Canada Myant Inc Full time

    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. Humans have a fundamental desire and need to be connected to our environment, family, community, and technology. This level of connection will create a...


  • Mississauga, Ontario, Canada Myant Inc Full time

    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 in a passive or...