Location: Remote US-Based Essential Functions<ul><li>Manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings as applicable.</li><li>Partners with Clinical Research Organization (“CRO”) to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed; revises scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.</li><li>Oversee monitoring activities at clinical CROs by reviewing visit reports, and any protocol deviations; attend monitoring visits as required.</li><li>Work in a team environment comprising of clinical operations, regulatory, technical operations, quality, and CROs to assess and meet data management needs; including ensuring data is accurately collected in an efficient and timely manner.</li><li>May assist the study Clinical Operations Lead with timeline maintenance and may lead smaller cross-functional team meetings with oversight of study Clinical Operations Lead</li><li>Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation</li><li>Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead</li><li>Uses operational and therapeutic expertise to optimize trial design and execution works with the study team to design clinical trial protocols and assists in developing/managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met; supports the creation of the ICF template, CRFs, etc.</li><li>Prepares and/or reviews study-related documents.</li><li>Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).</li><li>Assists in the management of study budget and maintains it within financial goals; including review of invoices against approved budget.</li><li>Ensures all clinical trials are executed in compliance with ICH/GCP guidelines/regulations and applicable SOPs: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.</li><li>Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.</li></ul>Qualifications<ul><li>Bachelor’s degree in a life science or a health-related field.</li><li>Three (3) years or more of progressive clinical management experience with the biotech / pharmaceutical industry or in a clinical research organization (oncology experience highly preferred but not required), global trial experience highly preferred.</li><li>Experience in full-cycle drug development required including participation in multi-disciplinary project teams working on phase I-IV global clinical studies</li><li>Prior experience supporting regulatory filings, inspections, and audits.</li><li>Available for approximately 25% travel both domestic and international, including overnight stays</li><li>Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.</li></ul> The U.S. target annual salary range for this remote, full-time, position is currently set at ($140,000-$156,500). 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

Clinical Trial Manager

CG Oncology

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