Senior Manager, Data Management

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

Essential Functions:Lead and oversee clinical data management activities, ensuring the integrity, quality, and timely delivery of clinical trial data.Provides hands-on clinical data management and vendor oversight of assigned clinical trials, including internal review and approval of deliverables.Provides input CRF design with the medical and clinical operation team according to clinical protocol and study data requirements, edit check specifications, CRF completion guidelines.Manages clinical data management activities throughout the life cycle of a clinical study, including the support of site monitoring and query generation/resolution.Manages data transfers from the CRO and reporting at required intervals and database locking and archiving at the end of the clinical study. Inclusive of creation and modification of Data Transfer Agreements.Monitors the tracking of key metrics on data entry, query status, and presenting metrics to clinical operations and field teams.Actively participate in hands-on data management tasks, including database setup, data cleaning, and database lock activities.Manage relationships with external vendors, including contract negotiation, performance evaluation, and oversight of deliverables.Provide project management leadership for data management projects, including resource planning, timeline management, and risk mitigation.Collaborate with cross-functional teams to ensure alignment of data management activities with overall project goals and timelines.Develop and implement data management processes and standards to ensure compliance with regulatory requirements and industry best practices.Mentor and provide guidance to junior staff members, fostering their professional development and growth.Serve as a key point of contact for internal and external stakeholders on data management-related issues.Collaborate with cross-functional teams on projects globally.

Qualifications:BS/BA in a relevant scientific discipline.Seven (7) years of progressive clinical data management experience within the biotech/pharmaceutical industry or in a clinical research organization.At least three (3) years of oncology therapeutic area experienceKnowledge of GCP, ICH Guidelines and use of good clinical data management practices.Ability to travel for company business <5%.

The U.S. target annual salary range for this remote, full-time, position is currently set at $165,000 - $175,000 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 visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

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.HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWSANNUAL PERFORMANCE BONUSESEQUITYSPECIAL RECOGNITION

Well-Being BenefitsIn addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet most 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.FULLY REMOTE WORK ENVIRONMENTREST AND RECHARGE BENEFITS - Unlimited Flexible Time OffHOLIDAYS – We observe 12 Holidays/yearRETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salaryHEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLifeHEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DCILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary PlansLIFE INSURANCE – Company Paid 1 x base salary + Voluntary PlansADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

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. 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.