Job Closed

This listing is no longer active.

BeOne Medicines

BeOne Medicines, formerly known as BeiGene, is a global next-generation oncology company founded in 2010 with the vision of expanding access to high-quality can

Director, Clinical Operations Compliance, GCP

Location

United States

Posted

120 days ago

Salary

$175.6K - $235.6K / year

Seniority

Lead

Postgraduate DegreeEnglishGCP

Job Description

Director, Clinical Operations Compliance, GCP

BeOne Medicines

• Identifying and anticipating potential issues impacting business goals • Leading global initiatives and working groups • Collaborating with study teams to ensure quality compliance • Designing study documents to ensure quality by design • Developing risk identification and management strategies • Consulting on business initiatives and tools for compliance • Maintaining expertise in global GCP guidance and regulations • Conducting quality issue trending and root cause analysis

Job Requirements

  • Impeccable ethics
  • Sound judgement and discretion
  • Demonstrated experience with planning and prioritizing
  • Strong organizational skills
  • Knowledgeable in stakeholder management
  • Proven interpersonal skills
  • Knowledge of evolving legal and regulatory environment
  • Understanding of corporate and organizational policies

Benefits

  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

Related Categories

Related Job Pages

More Clinical Operations Jobs

ClinChoice logo

Clinical Project Manager II

ClinChoice

The Standard of Excellence

OtherRemoteTeam 1,001-5,000Since 1998H1B Sponsor

• Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project. • Apply principles, concepts and techniques for effective and proactive project management of a clinical study. • Balances resource constraints (i.e. time, money, people, and equipment) against deliverables. • Develop clinical study budget and may assist in quarterly departmental budget reviews. • Seeks input from higher-level clinical experts or program management as issues warrant. • Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department. • Implement and maintain risk-based monitoring processes to drive efficient and effective study management. • Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance. • Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance.

United States
Job Closed

Senior Clinical Care Navigator, Substance Use Disorder

Carrum Health

Carrum Health is a healthcare company that partners with employers to provide employees access to high-quality medical care through a network of top providers. Carrum Health aims t

Role Description At Carrum, we are transforming how we pay for, deliver and experience healthcare. If you are passionate about changing healthcare and want to finally get rid of surprise bills, poor quality, and high prices, while thriving in an entrepreneurial, cutting-edge environment, we would love to connect with you. The heart of Carrum Health is a seamless and highly personalized patient experience, enabled by expert care coordination and navigation. As a senior member of the Care Team, the Senior Clinical Care Navigator, Substance Use Disorder serves as the lead architect for the most complex patient journeys and multi-system coordination needs for our Substance Use Disorder patients. The SCCN masters the intersection of clinical excellence and operational strategy, managing high-acuity cases while simultaneously refining the workflows that drive care continuity. By collaborating with clinical, operational, and external partners, the SCCN ensures elite patient outcomes and actively shapes how care delivery is designed and executed at scale across the organization. You’re excited about this opportunity because you will: - Take ownership of the clinical and operational success of your Substance Use Disorder line, ensuring patients achieve the best possible health outcomes. - Use your technical writing skills to transform complex, messy workflows into clear, scalable Standard Operating Procedures (SOPs) that empower a growing team. - Influence our care models, setting the gold standard for navigation workflows across the organization. - Act as the critical bridge between COE (Center of Excellence) clinical experts and our clinical operations teams, ensuring business logic always aligns with clinical best practices. - Partner with cross-functional teams to ensure our internal tools and processes are built to support nuances and reduce the "administrative burden" on care teams. Qualifications - 7+ years of clinical experience in Substance Use Disorder and Behavioral Health patient care with an LCSW, LCPC, LSW, or LPC License with at least 3+ years of direct patient care or coordination experience. - Substance Use Disorder certification is strongly encouraged. - Nice to have: Spanish Speaking preferred. - Nice to have: Direct patient experience in broader behavioral health including eating disorders, other addictions (gambling, sex, digital), and acute mental health needs. Requirements - You have demonstrated progression and sustained performance within patient services, care navigation, access operations, or related internal roles. - You have the proven ability to manage complex workflows, high-impact responsibilities, and advanced patient scenarios. - You maintain a consistent track record of reliability, growth, and increasing scope of responsibility. - You are familiar with Google Suite, Microsoft Office, Talkdesk, and other standard applications. - You’re committed to providing the highest level of service through the right mix of empathy, professionalism, and integrity. - You have the ability to cut through the noise of a fast-paced start-up environment and affect real change. - You appropriately handle confidential information and adhere to HIPAA requirements. - You have strong “patient first” values. - You are comfortable interacting through a variety of tech platforms and can quickly learn new software. Benefits - Stock option plan. - Flexible schedules and remote work. - Chicago and San Francisco offices available. - Self-managed vacation days, within reason. - Paid parental leave. - Health, vision, and dental insurance. - 401K retirement plan. Company Description We’re a health tech company that brings value-based care to the masses. We help employers deliver a memorable patient experience, immediately lower healthcare costs, and drive better outcomes and achieve this through the power of technology and human-centered design. Since launching in 2014, we’ve partnered with Fortune 500 employers and top hospitals across the nation. We’ve been recognized by Harvard Business School and featured in TechCrunch, The Los Angeles Times, Washington Post, and Modern Healthcare. We believe we’re only scratching the surface of our opportunity and we’re looking for incredible people like you to help us realize our full impact. Carrum Health is an equal opportunity employer and encourages all applicants from every background and life experience.

United States
Job Closed
Alimentiv logo

Senior Clinical Operations Lead

Alimentiv

Learn about career opportunities, our culture, and our mission to improve human health.

OtherRemoteTeam 201-500Since 2020H1B No Sponsor

• Responsible for the clinical operations of a project within a defined regional/global level • Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites • Acts as a primary liaison between the CRAs and the clinical project team • Project specific training of CRAs and conducting assessment visits • Implementation of enrollment and recruitment strategies and preparation of the monitoring plan • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions • Development of study tools for site and CRA use, review visit reports, review and track protocol deviations

District Of Columbia + 8 moreAll locations: District Of Columbia | Florida | New Jersey | New York | North Carolina | Maryland | Massachusetts | Pennsylvania | Washington
$86K - $143K / year
SonderMind logo

Clinical Operations Associate

SonderMind

SonderMind is a tech company that connects people with licensed therapists who are available for both face-to-face and online, video telehealth sessions. SonderMind understands tha

• Collaborate with clinical, customer support, product, and analytics teams to build scalable processes ensuring timely care for high-risk clients. • Triage daily clinical quality cases, including gaps in care, documentation requests, and member outreach, ensuring timely resolution. • Track and maintain key clinical quality metrics (HEDIS, STARs, preventive care measures) and support dashboards and internal reporting. • Assist with preparation, validation, and submission of payer-required quality reports. • Support planning and execution of clinical projects, including provider education and value-based care initiatives. • Coordinate cross-functional tasks, maintain project trackers, and provide progress updates to stakeholders. • Monitor adherence to SLAs, workflows, and escalation protocols, flagging issues and supporting corrective actions. • Maintain accurate documentation, audit-ready files, and evidence for quality programs and accreditation activities. • Assist in implementing process improvements to enhance efficiency and scalability of clinical programs.

Colorado
$68K - $78K / year
Job Closed