About the role<ul><li>Location: Remote US-Based</li></ul>Essential Functions:<ul><li>Implement strategy for in-house, regional monitoring activities on assigned studies applying a risk-based approach when indicated.</li><li>Lead monitoring activities on assigned studies. Activities including, however not limited to, review of protocols, CRFs and completion guidelines, study manuals and other related documents.</li><li>Author and/or review Clinical Monitoring Plan in collaboration with Sr. CPM and ensure CRA compliance to current plan.</li><li>Manage the CRA monitoring visit schedule for each assigned study ensuring visit frequency and scheduled time on site aligns with risk-based indicators and site metrics.</li><li>Review and finalize visit reports for regional CRAs managed by CG Oncology according to study timelines. Follow up with CRAs regarding outstanding trip reports and follow-up letters.</li><li>Maintain, and/or act on metrics related to CRA performance or site status.</li><li>Support CRAs and CPM with the implementation of site corrective actions related to issues identified during monitoring activities.</li><li>Track and report to study team and leaders on compliance, trends and metrics related to monitoring and site management.</li><li>Support TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents as needed.</li><li>With direction from the CPM, manage the monitoring oversight strategy, including risk-based approaches, to assess the quality and compliance of CRO or FSP partners on assigned studies.</li><li>Manage or conduct monitoring oversight visits (MOVs) with CRO or FSP CRAs to assess compliance to the protocol and Clinical Monitoring Plan and document results of the visit.</li><li>Review monitoring visit reports from CRO CRAs and escalate monitoring trends or findings to the CPM</li><li>Mentors and provides leadership and direction to the CRA team members on study related questions from start-up through closure</li><li>Ensure adequate resourcing for CRAs on assigned studies; work with CPM to plan for CRA reassignment or acquisition of additional resources.</li><li>Support CRAs, study team, and Quality with responses to audits or inspections.</li><li>Support development and manage Clinical Monitoring budget requirements for assigned studies.</li></ul>Qualifications:<ul><li>Bachelor’s degree (relevant discipline preferred) or experience may substitute for minimum educational requirements.</li><li>Minimum of five (5) years of monitoring experience for biopharmaceutical or Contract Research Organization (CRO) in late phase oncology studies.</li><li>Thorough understanding of all applicable FDA, ICH and GCP/GxP regulations and guidelines.</li><li>Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.</li><li>Ability to travel up to 50% for site visits and meetings.</li></ul> The U.S. target annual salary range for this remote, full-time, position is currently set at ($139,000-$153,000). The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role. Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid. Total RewardsCG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.<ul><li>HIGHLY COMPETITIVE SALARIES   </li><li>ANNUAL PERFORMANCE/MERIT REVIEWS</li><li>ANNUAL PERFORMANCE BONUSES</li><li>EQUITY</li><li>SPECIAL RECOGNITION</li></ul>Well-Being BenefitsIn addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to the meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.<ul><li>FULLY REMOTE WORK ENVIRONMENT</li><li>REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off</li><li>HOLIDAYS – We observe 12 Holidays/year</li><li>RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary</li><li>HEALTH (MEDICAL, DENTAL, VISION) – PPOs &amp; HDHP – Cigna/Principal</li><li>HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC</li><li>ILLNESS &amp; DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans</li><li>LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans</li><li>ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More</li></ul> CG Oncology is an Equal Opportunity Employer:All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.

CG Oncology

Manager, Clinical Monitoring

CG Oncology

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