Clinical Trials Operations Manager
4 weeks ago
Job Summary
Advarra is seeking a highly skilled Clinical Trials Operations Manager to join our team. As a Service Owner, you will be responsible for the success of assigned services, including driving service development and expansion, providing updates to leadership, and acting as the primary liaison and expert for the service across the company.
Key Responsibilities
- Work closely with the Business Operations Services team to complete calendars, budget setups, Medicare coverage analyses, budget negotiations, EDC study design, and eReg data migration services.
- Provide Quality Assurance oversight and collaborate on required changes prior to delivering the end product to the customer.
- Act as a subject matter expert within Forte to ensure guidelines and builds are in accordance with the latest regulations and in alignment with the chosen industry certification provider.
- Act as a thought leader in the industry, working with the marketing team to promote Advarra services and expert knowledge across and beyond Advarra's customer base.
- 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.
- Train or oversee the training of new United States-based Business Operations Services team members performing coverage analysis and budget negotiation services, ensuring quality and consistency of customer deliverables.
- Ability to be flexible to collaborate internationally as required.
Requirements
- High School diploma required.
- 5+ years of directly related experience in a clinical trials environment, and certification with the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) as a certified clinical research professional within three years of employment.
- Knowledge of FDA and Medicare regulations related to clinical trials is required.
- Medical coverage determination experience is required.
Preferred Qualifications
- Degree in Science, healthcare, or related field preferred.
- Research, medical billing, clinical, or healthcare compliance/auditing experience are preferred.
- Experience with Clinical Trial Management Systems preferred.
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