Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Connecting the clinical research ecosystem, Advarra delivers solutions through a site-centric approach that unifies and accelerates the drug development lifecycle, making clinical trials safer, smarter, and faster.

General Summary:

The Business Operations Services Manager will play a critical role in growing and improving professional services provided by our Business Operations Services team, operating both out of India and the United States. This will help reduce effort for our customers and reduce study activation timelines at each organization.

Principal Duties & Responsibilities:

• Complete clinical research study site specific internal budgets and negotiate reimbursement with sponsors and CROs based on the internal budget and coverage analysis 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.

Education:

• High School diploma required.
• Degree in Science, healthcare, or related field preferred.

Experience:

• 3+ years of directly related experience in a clinical trials environment specific to the creation of site specific internal budgets and negotiating budgets directly with sponsors and CROs, Directly related experience may substitute on a year-for-year basis for the required education.
• Knowledge of FDA and Medicare regulations related to clinical trials is required.
• Medical coverage determination experience is preferred.
• Research, medical billing, clinical or healthcare compliance/auditing experience are preferred.
• Experience with Clinical Trial Management Systems preferred.

Knowledge, Skills, Abilities:

• Ability to be flexible to collaborate internationally as required.
• Innate curiosity about processes, systems and user functionality.
• Proactive personality who enjoys working with others.
• Ability to identify opportunities for improvement and work proactively and collaboratively with team to drive change.
• Excellent customer service skills.
• Strong time management and organization skills; ability to determine how to simplify complex tasks and effectively communicate what needs to be done.
• Excellent communication skills, including listening, writing, and speaking.
• Demonstrated ability to effectively negotiate and build consensus with various audiences, plan and manage project activities while facilitating and developing business strategy through internal and external relationships.
• Ability to present and lead customer-facing discussions with confidence and conciseness.
• Demonstrated accountability in project ownership and solution-oriented work approach.
• Proficient in the use of Microsoft Word, Excel and PowerPoint. Proficient in email.

Physical and Mental Requirements:

• Sit or stand for extended periods of time at stationary workstation.
• Regularly carry, raise, and lower objects of up to 25 Lbs.
• Learn and comprehend basic instructions.
• Focus and attention to tasks and responsibilities.
• Verbal communication; listening and understanding, responding, and speaking.

#mogul

EEO Statement:Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state, or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated. EEO/M/F/Disabled/Vets

Advarra employees must be fully vaccinated as a condition of employment unless a medical or religious exemption is approved as a reasonable accommodation. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen. New hires must be fully vaccinated or have received approval of an exemption as a reasonable accommodation as of their first day of employment.

#LI-MM1

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)