Senior Clinical Research Specialist

Job Description

Job Description

About the role:
The Senior Clinical Research Specialist will join the Urology Biostatistics and Real World Evidence team. This role supports key commercialized products by developing and executing clinical research activities from real-world data sources and driving long-term evidence strategies. This role creates and maintains all documentation pertaining to clinical research activities, designs studies utilizing these non-clinical trial data sources, builds cohorts through data element identification and mapping, and collaborates cross-functionally to ensure cohesiveness and appropriateness of research scope.

Responsibilities will include:

• Support strategic growth of the team's Real-World Evidence (RWE) capabilities and demonstrate ROI in the use of these new clinical data sources
• Plan and execute feasibility and analysis of the Urology RWE studies programmatically utilizing data science techniques and contribute to post-market documentation, publications, and other documents as needed.
• Design studies utilizing administrative claims, Electronic Health Records (EHR), and other RWE data sources by applying clinical research methodologies (e.g., research question development, population inclusion/exclusion, reduction of bias, etc.)
• Develop coding definitions utilizing reimbursement code sets (ICD-10-CM, ICD-10-PCS, CPT, etc.) and medical terminologies (SNOMED, LOINC, RxNorm, etc.) for populations, outcomes, and co-variates of interest in the Urology space.
• Collaborate cross-functionally with Clinical Strategy, Scientific Communication, Biostatistics, Medical Safety, Legal, and Compliance to design and run RWE studies.
• Manage internal and external project materials and timelines.
• Participate as a key team member on process development and improvement efforts to meet Urology VIP goals.

Required Qualifications:

• Minimum of a Bachelor's Degree in a related field and 4 years of related work experience (including data analytics, data management, health economics, medical affairs, clinical risk, clinical trial operations, clinical safety, quality assurance or regulatory affairs) or advanced degree (PhD, research-based MS, MD, RN/DVM) in a related field with 4+ years of related work experience
• Expertise in leveraging medical coding systems and terminologies for research applications (ICD-9/10, CPT, SNOMED, LOINC, RxNorm, etc.)
• Proven experience using Python, R, other software for exploring, structuring, and analyzing data sets, relational data modeling and querying expertise (SQL)
• Ability to work in a team environment and possess clear, concise communication skills – both written and verbal

Preferred Qualifications:

• Preferred medical device or clinical experience in Urology
• Prior or current experience in retrospective research design with Real World data including claims data inclusive of Charge Master Data and/or Electronic Health Record (EHR) data
• Proven scientific writing experience
• Proven Physician-facing experience