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.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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      Role: SENIOR CLINICAL DATA MANAGER

Location: Remote US-Based

Essential Functions:

• The Senior Clinical Data Manager is responsible for managing and overseeing all Clinical Data Management (CDM) activities for assigned studies required to meet corporate goals and timelines.
• This incumbent is responsible for the execution of clinical data capture, data review and cleaning, DM documentation, as well as study specific vendor management from study start-up to database lock.
• This incumbent is responsible for demonstrating the ability to ensure an investigation is conducted according to GCP regulations and internal control documents to protect the rights, safety, and well-being of subjects and the accuracy and validity of the trial data.

Qualifications:

• Bachelor's degree 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 experience.
• Experience in CRO communications, oversight, and management by working effectively both in a core team and functional team settings.
• Experience working cross functionally and supporting Clinical Operations, Clinical Development, Safety, Biostatistics, Regulatory, Medical and Quality Assurance functional areas.
• Demonstrated ability to ensure an investigation is conducted according to GCP regulations and internal control documents to protect the rights, safety, and well-being of subjects and the accuracy and validity of the trial data.
• Demonstrates a strong understanding of the medical aspects of clinical trials, Clinical Research Operations, and Structure of CMC, key terms, processes, compliance, and timelines as they relate to advancing Biotechnology research through the pre-clinical to clinical phases.
• Demonstrates a strong understanding of Clinical Research Operations, and Structure of key terms, processes, compliance, EDC systems (RAVE and Zelta preferred) and timelines.
• Demonstrated understanding of the critical importance of rigorous data generation and disciplined stewardship of the data.
• Knowledge 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 $135,000 - $150,000. 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 Rewards

CG 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 REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In 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 ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS – We observe 12 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
• ADDITIONAL 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.