EHR Analyst

EHR Analyst - Real-World Evidence (RWE)

Remote

Long term contract

Overview:

We are seeking a highly skilled NextGen/e-Clinical Works Analyst to join our team in advancing our Real-World Evidence (RWE) capabilities within the pharmaceutical industry. This role will be instrumental in leveraging electronic health records (EHRs) and clinical data to drive insights that inform decision-making across various stages of drug development and commercialization.

Key Responsibilities:

1. System Optimization: Collaborate with cross-functional teams to optimize NextGen or e-Clinical Works systems to efficiently capture, standardize, and integrate clinical data for RWE generation.
2. Data Management: Design and implement data management strategies to ensure the quality, integrity, and security of clinical data collected from healthcare providers and clinics.
3. RWE Analytics: Utilize advanced analytical techniques to analyze large-scale clinical data sets and derive meaningful insights that contribute to evidence generation for regulatory submissions, market access, and post-market surveillance.
4. Protocol Development: Assist in the development of study protocols and analytical plans for RWE studies, ensuring alignment with regulatory requirements and industry best practices.
5. Collaboration: Foster strong partnerships with healthcare providers, clinics, and research organizations to facilitate data sharing agreements and streamline data acquisition processes.
6. Regulatory Compliance: Stay abreast of evolving regulatory guidance and industry standards related to RWE generation, ensuring compliance with relevant regulations such as GDPR, HIPAA, and 21 CFR Part 11.
7. Cross-Functional Support: Provide technical expertise and support to cross-functional teams, including Medical Affairs, Market Access, Clinical Development, and Commercial teams, to incorporate RWE insights into strategic decision-making.

Qualifications:

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, or related field; advanced degree (MS, PhD) preferred.
• Proven experience (3+ years) working with NextGen, e-Clinical Works, or similar electronic health record (EHR) systems in a pharmaceutical or healthcare setting.
• Strong proficiency in data manipulation, analysis, and visualization using tools such as SQL, Python, R, or SAS.
• Familiarity with RWE methodologies, including retrospective cohort studies, observational research, and comparative effectiveness analyses.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders and translate technical concepts to non-technical audiences.
• Experience with regulatory submissions and compliance in a pharmaceutical or healthcare environment is desirable.
• Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.