CVS Health
Sanford, Florida, United States
Clinical Data Management & Integrations, Senior Manager
Posted over 1 month ago
Job Description
Job Description
Job Purpose and Summary:
The Clinical Data Management & Integrations, Senior Manager will implement and oversee data management processes and solutions for CTS. In this role you will collaborate with enterprise shared service IT stakeholder (Integration Developers, Digital Teams, virtual care platform team, Epic Care Analysts, Billing, Enterprise Analysts) to lead preliminary discoveries for business opportunities and execute the CTS enablement roadmap. Deliverables will include end to end Epic conduct workflow from digital recruitment to study close out in accordance with Good Clinical Practices. You will also work cross functionally with Operations and Quality to support reporting and trending requirements.
What You'll Do:
? Lead study opportunity discoveries to inform feasibility
? Inform roadmap planning
? Create and implement policies, processes, and procedures related to clinical trial data management in accordance with published standards, regulations, and guidance
? Lead enterprise stakeholders to execute end to end IT projects within aligned upon time, scope, and budget to meet business goals and objectives.
? Create and implement study-specific clinical data management solutions and processes such as study specific smart form development, EHR to EDC integrations, and dashboard incorporations.
? Assure projects are compliant with SOPs, local regulations, and CFR, ICH, and GCP guidelines
? Coordinate remote review of clinical data within the EDC system.
? Collaborate with Operations and Quality to implement data trending and reporting solutions
? Implement data security and confidentiality measures for PHA data in accordance with HIPAA regulations
Required Qualifications
? 8+ years of work experience in a Pharmaceutical or Clinical Operations Environment
Preferred Qualifications
Who You Are:
? Ability to manage multiple priorities within various clinical trials.
? Ability to reason independently and recommend specific solutions in clinical settings.
? Working knowledge of current ICH GCP guidelines and applicable regulations.
? BS/BA (or equivalent) in computer science, IT, or engineering with a minimum of 4 years direct experience in data architecture or equivalent level of education and experience.
Education
Bachelor's Degree
Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
Job Purpose and Summary:
The Clinical Data Management & Integrations, Senior Manager will implement and oversee data management processes and solutions for CTS. In this role you will collaborate with enterprise shared service IT stakeholder (Integration Developers, Digital Teams, virtual care platform team, Epic Care Analysts, Billing, Enterprise Analysts) to lead preliminary discoveries for business opportunities and execute the CTS enablement roadmap. Deliverables will include end to end Epic conduct workflow from digital recruitment to study close out in accordance with Good Clinical Practices. You will also work cross functionally with Operations and Quality to support reporting and trending requirements.
What You'll Do:
? Lead study opportunity discoveries to inform feasibility
? Inform roadmap planning
? Create and implement policies, processes, and procedures related to clinical trial data management in accordance with published standards, regulations, and guidance
? Lead enterprise stakeholders to execute end to end IT projects within aligned upon time, scope, and budget to meet business goals and objectives.
? Create and implement study-specific clinical data management solutions and processes such as study specific smart form development, EHR to EDC integrations, and dashboard incorporations.
? Assure projects are compliant with SOPs, local regulations, and CFR, ICH, and GCP guidelines
? Coordinate remote review of clinical data within the EDC system.
? Collaborate with Operations and Quality to implement data trending and reporting solutions
? Implement data security and confidentiality measures for PHA data in accordance with HIPAA regulations
Required Qualifications
? 8+ years of work experience in a Pharmaceutical or Clinical Operations Environment
Preferred Qualifications
Who You Are:
? Ability to manage multiple priorities within various clinical trials.
? Ability to reason independently and recommend specific solutions in clinical settings.
? Working knowledge of current ICH GCP guidelines and applicable regulations.
? BS/BA (or equivalent) in computer science, IT, or engineering with a minimum of 4 years direct experience in data architecture or equivalent level of education and experience.
Education
Bachelor's Degree
Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.
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