Clinical Research Services Manager

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Overview Summary

Deliver clinical research services that enhance research effectiveness, study activation timelines, and billing compliance and which are both specific to the software applications (Clinical Trial Management System as well as Electronic Data Capture) of Advarra and are software agnostic.

Job Duties & Responsibilities

Service Delivery:

• Complete clinical research Medicare coverage analysis, coding, internal budgets and negotiate reimbursement with sponsors and CROs based on the internal budget and on behalf of customers.
• Work closely with the Business Operations Services team, based in India, who will also 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.

Account Management:

• 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.

Location

This role is open to candidates working remotely in the United States

Basic Qualifications

• 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.

Preferred Qualifications

• Research, medical billing, clinical or healthcare compliance/auditing experience are preferred.
• Experience with Clinical Trial Management Systems preferred.
• Coding experience is required, certification is preferred.
• Knowledge of pharmaceutical industry regulations and Good Clinical Practice guidelines related to human research.
• A highly personable nature that fosters teamwork.
• Excellent communication skills – oral as well as written.
• High energy and positive attitude towards working in a culturally diverse environment.
• A passion for ensuring outstanding customer support with a solutions-oriented attitude.
• Proactive and takes ownership in all tasks from start-to-finish.

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary workstation
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Learn and comprehend basic instructions
• Focus and attention to tasks and responsibilities
• Verbal communication; listening and understanding, responding, and speaking

Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.

Pay Transparency Statement

The base salary range for this role is $​61,200 - $​104,100. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.