principal research specialist, clinical insights.

• hopkins , minnesota

• posted june 10, 2024

job details

summary

• $50 - $60 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48289

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Hopkins, Minnesota

job type: Contract

salary: $50 - 60 per hour

work hours: 8 to 4

education: Bachelors

responsibilities:

Come join the company's Urology Clinical Sciences organization where we partner together to advance Urology for patients. We are looking for a Principal Research Specialist to join our Urology Clinical Insights 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.

• Support strategic growth of our 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 company 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 ing 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, Sci Comm, 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.

Quality System Responsibilities:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

• For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the company Quality Policy.

• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

qualifications:

Required

• Bachelor's Degree in a related field and 9+ 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 7+ years of related work experience

• Expertise in leveraging medical coding systems and terminologies for research applications (ICD-9/10, CPT, SNOMED, LOINC, RxNorm, etc.)

• Significant 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 - written and verbal

• Excellent problem solving and analytical skills

Preferred

• Medical device or Clinical experience relating to Urology

• Experience in retrospective research design with Real World data including Claims data inclusive of Charge Master Data and/or Electronic Health Record (EHR) data

• Scientific writing experience

• Physician-facing experience

skills: Clinical research, R Language, Clinical Study Design

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.