Lead data architect job description

Under the direction of a Manager or Senior Manager, the Clinical Data Lead is an integral part of the account team as the subject matter expert, ensuring partner satisfaction through management of all quality tasks including new team member orientation, pre-submission cleaning of cases, validation of abstractor accuracy (IRR), completion of Fallout Reviews and the Second Look process.

Quality Management: Conduct orientation to medical records for new abstraction team members Manage the green-lighting process and completion of on-going IRR, identifying any performance concerns in collaboration with the Clinical Services Lead and escalating concerns to Senior Manager/ManagerEffectively manage the fallout review/exception/occurrence reporting and Second Look process, ensuring accurate reporting, and partnering with the Clinical Services Lead to ensure partner notification and review Provide follow-up/feedback/education to the project team on quality issues or trends identified during greenlighting, on-going IRR, second looks, pre-submission cleaning, review of project quality trends, etc.Collaborate with Clinical Services Lead and Senior Manager/Manager to identify quality trends in the data with respect to internal team performance, and also identify hospital quality trends to share with partners Mentor, train and provide guidance to new hires during the onboarding process at assigned facilities Maintain and share abstraction team support documents, including Measure Detail and Documentation Clarification Forms, regularly updating with new measures and/or partner EMR changes Complete the 1st pass of pre-submission clean-up, update cases when missing documentation is provided Subject matter expert in assigned registry or measure. Provide expert abstraction support - 15% - 20% abstraction Other quality tasks, as assigned

Partner Management:Attend new partner orientation in order to orient new team members as added to the project Work closely with the Clinical Services Lead, as needed, for case-specific questions Other partner tasks, as delegated by the Clinical Services Lead or the Senior Manager/Manager

Required Skills/Abilities: Demonstrates high standards for accuracy and attention to detail Demonstrates technical savvy and strong desire to learn new systems and technology Thrives working independently and takes ownership of projects Consistently and clearly communicates, adjusting style and tone as needed to effectively collaborate with hospital partners, peers, abstractors and others Demonstrates strong self-organizational and time management skills to concurrently manage multiple accounts, adjusting as needed to shifting timelines and priorities Adapts to changes in project timelines, requirements, and assignments Maintains a high degree of responsibility in keeping PHI secure and confidential

Education and Experience:3+ years direct data abstraction experience in the applicable division/service line Other certifications as required by applicable measure of registry Exposure to multiple patient medical record systems (EMRs) and clinical databases1+ years providing coaching and guidance to teams (preferred) RN, LPN, RT, RVT, or RCIS credentials (preferred) Intermediate proficiency with MS Office (Microsoft Excel)

At Q-Centrix, we hire people who love learning, value innovation, and believe in our mission and values to improve outcomes in healthcare. We applaud qualified applicants who are accountable and committed to producing quality work. As an Equal Opportunity Employer, we support and value diversity, dignity, and respect in our work environment, and are committed to creating an inclusive environment in which everyone can thrive.

We employ people based on the needs of the business and the job, and their individual professional qualifications. Here's what does not impact our employment decisions: race, religious creed, religion, color, sex, sexual orientation, pregnancy, parental status, genetic information, gender, gender identity, gender expression, age, national origin, ancestry, citizenship, protected veteran or disability status, health, marital, civil union or domestic partnership status, or any status or characteristic protected by the laws or regulations in locations where we operate. If you are an individual with a qualified disability and you need accommodation during the interview process, please reach out to your recruiter.
We celebrate and embrace these differences and take pride in our commitment to being an equal opportunity team.

About this role

The Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They will provide operational leadership and be accountable for of all Clinical Data Management activities throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR).

What you'll do

Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.

Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)

Develops risk mitigation or action plans and oversees execution when appropriate.

Reviews operational performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution.

Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed.

Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM Portfolio Lead, DM management. Develops appropriate risk mitigation, as needed.

Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.

Who You Are

You are recognized as an operational specialist in clinical data flow and study execution by all cross-functional groups. You enjoy leading project teams , thrive on project deadlines, and are passionate about the clinical trial arena.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive

This is a hybrid/remote position within the Software Defined Vehicle (SDV) organization and does not require you to be onsite full time to perform most effectively. You are empowered to work remotely or on location as frequently as desired. The position may require occasional onsite work and travel based on business needs. Do you imagine a world of zero crashes, zero emissions, and zero congestion? We do! To reach this ambitious goal we are creating the next generation vehicle compute platform. Ultifi is transforming the way automotive software is developed and deployed, creating a ubiquitous connection with cloud.Data governance is so much more than compliance. Data must be accurate, available, and useful. The systems we put in place for data governance must address “traditional” governance concepts, with a strong focus on accuracy, usability, and waste elimination. Data governance tools must not be “piled on top” of existing business processes but be integrated within them to make the business more effective.
Job Description:
The Software Defined Vehicle (SDV) Data Governance Lead will be responsible for the definition and integration of strategies and process for data originating from the Ultifi Platform. In this role, you will work with multiple teams across GM to establish processes that will ensure appropriate governance from data creation to consumption.

Responsibilities Include:
In partnership with these key stakeholders, develop the SDV Data Governance operational strategy and corresponding frameworks, aligning existing processes, standards, and priorities Develop and implement short and long-term roadmaps for maturing the organizations data governance approach Work in partnership with legal and compliance stakeholders to ensure adherence to global regulatory requirements Provide support in performing data privacy and compliance for key issues related to PII, CCPA, Right-To-Repair, and other regulations on a global level with the Ultifi platform Support metadata management processes and standards to ensure data integrity and standardization Help capture data quality rules and metrics and investigate data quality process issues in collaboration with the DataOps team

Additional Job Description
Qualifications:
Degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience Experience with global data requirements and regulations8+ years of experience working with large-scale data sets in an enterprise environment Industry experience in solution/technical architecture in the cloud Experience with Microsoft Azure and PurviewStrong background and working knowledge of data quality improvements

Compensation and Benefits:
GM's Work Appropriately philosophy supports our foundation of inclusion and provides employees the flexibility to work where they can have the greatest impact on achieving our goals, dependent on role needs.GM's comprehensive compensation and benefits plan is carefully designed and thoroughly benchmarked against the companies that we compete for talent in the local market.
The goal of the General Motors of Canada total rewards program is to support the health and well-being of you and your family. Our comprehensive compensation plan currently includes the following benefits, in addition to many others:
Paid time off including vacation days, holidays, and supplemental benefits for pregnancy, parental and adoption leave.Healthcare, dental and vision benefits including health care spending account and wellness incentive.Life insurance plans to cover you and your family.Company and matching contributions to a Defined Contribution Pension plan to help you save for retirement.Global recognition program for peers and leaders to recognize and be recognized for results and behaviors that reflect our company values.Tuition Assistance and Employee Assistance Program. GM Vehicle Purchase Plan for you, your family and friends.

About GM
Our vision is a world with Zero Crashes, Zero Emissions and Zero Congestion and we embrace the responsibility to lead the change that will make our world better, safer and more equitable for all.

Why Join Us
We aspire to be the most inclusive company in the world. We believe we all must make a choice every day - individually and collectively - to drive meaningful change through our words, our deeds and our culture. Our Work Appropriately philosophy supports our foundation of inclusion and provides employees the flexibility to work where they can have the greatest impact on achieving our goals, dependent on role needs. Every day, we want every employee, no matter their background, ethnicity, preferences, or location, to feel they belong to one General Motors team.

Diversity Information
General Motors is committed to being a workplace that is not only free of discrimination, but one that genuinely fosters inclusion and belonging. We strongly believe that workforce diversity creates an environment in which our employees can thrive and develop better products for our customers. We understand and embrace the variety through which people gain experiences whether through professional, personal, educational, or volunteer opportunities.

We encourage interested candidates to review the key responsibilities and qualifications and apply for any positions that match your skills and capabilities.

Equal Employment Opportunity Statement
Accommodation is available for applicants with disabilities. Should you be contacted by General Motors of Canada, please advise if you require accommodation. General Motors of Canada values diversity and is an equal opportunity employer.