200+ applicants

This job has closed.

Company

Original Job Post

Advarra · 5 days ago

Business Operations Services Sr Analyst

United States

Full-time

Remote

Senior Level

4+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Pharmaceutical

Hiring Manager

Mary Moore - SHRM CP, CIR, CDR

Insider Connection @Advarra

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Complete clinical research study site specific Medicare coverage analysis, coding, internal budgets, and negotiate reimbursement with sponsors and CROs.

Work closely with the Business Operations Services team in India to complete site-specific internal budgets and Medicare coverage analyses.

Provide Quality Assurance oversight and collaborate on any required changes prior to delivering internal budgets and coverage analyses to the customer.

Act as a subject matter expert to ensure guidelines and builds are in accordance with the latest regulations and in alignment with the chosen industry certification provider.

Communicate with customers, including Clinical Trial Office administration, investigators, and study teams upon completion of services requiring communication.

Act as a liaison and escalation point for any requested changes or questions from customers.

Review, understand, and apply information in clinical research protocols, Informed Consent Forms, Clinical Trial Agreements, and other relevant study-related documents when managing or conducting quality assurance.

Define processes for internal and external workflows to ensure quality and efficiency, and excellent customer communication; identify and lead continuous improvements to processes over time.

Ability to be flexible to collaborate internationally as required.

Perform other job-related duties as assigned.

Act as primary point of contact for designated customers.

Lead customer kick-off calls as needed for introducing specific services.

Determine monthly workload related to each customer.

Maintain high level quality and customer SLAs for all services.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical TrialsMedicare RegulationsFDA RegulationsCodingClinical Research MethodologyClinical GuidelinesPharmaceutical Industry RegulationsStakeholder ManagementMS OfficeBusiness SoftwareProblem-SolvingHard WorkingCommunicationTeamworkOrganizational SkillsResearchMedical BillingClinicalHealthcare ComplianceAuditingClinical Trial Management Systems

Required

4+ years' work experience directly related in a clinical trials environment specific to the creation of Medicare coverage analysis, site specific internal budgets, and negotiating budgets directly with sponsors and CROs.

Knowledge of FDA and Medicare regulations related to clinical trials is required.

Coding experience is required, certification is preferred.

Sound knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research.

Knowledge of pharmaceutical industry regulations and Good Clinical Practice guidelines related to human research.

Expected to work independently, as well as in a team environment.

Excellent organizational and administrative abilities

Ability to liaise with key stakeholders across the organization.

Familiarity with MS Office and various business software.