Clinical Trials Scientist

at  CG ONCOLOGY INC

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.

Role: Clinical Trials Scientist
Location: Remote US-Based

Essential Functions:

• Focuses on the strategic design, management, oversight, and effective execution of global clinical studies (Phase II-III) including, but not limited to, clinical strategy and design, protocol writing, clinical operations, data management, statistical analysis, and reporting and interpretation of clinical data.
• Works in a team environment comprising Clinical Operations, Regulatory Affairs, Safety, Clinical Supply Chain, Quality Assurance, and Clinical Research Organizations/external vendors to deliver and drive the completion of all clinical activities on time and within budget.
• Participates in investigator meetings.
• Participates in writing protocols, clinical study reports, and review clinical trial documents.
• Participates in the preparation of key regulatory documents including pre-submission documents and briefings, pre-market and other meetings with the FDA and other regulatory agencies, as needed.
• Participates in the preparation of study budgets; negotiation of contracts and vendors; supports invoice review through payment.
• Oversees vendors in conjunction with study managers to ensure ensuring compliance with all protocol and regulatory requirements using appropriate Quality Assurance procedures.

Qualifications:

• Bachelor’s Degree in a relevant scientific discipline
• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including clinical investigators and other clinical staff
• Proficient in Medical Terminology and medical writing skills
• Knowledge of ICH, GCP, and other relevant regulatory guidelines
• Proven ability to analyze clinical information succinctly and efficiently with strong written communication – especially as it relates to developing clinical protocols, assessing the quality of data, and presenting trial results
• Experienced in a fast-paced, high-growth company environment with minimal direction and a high-degree of independence and able to adjust workload based on changing priorities
• Available for approximately 10% travel both domestic and international, including overnight stays
• Flexible work hours to accommodate meetings in the evenings

The U.S. target annual salary range for this remote, full-time, position is currently set at $140,000 - $160,000. 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.

• Focuses on the strategic design, management, oversight, and effective execution of global clinical studies (Phase II-III) including, but not limited to, clinical strategy and design, protocol writing, clinical operations, data management, statistical analysis, and reporting and interpretation of clinical data.
• Works in a team environment comprising Clinical Operations, Regulatory Affairs, Safety, Clinical Supply Chain, Quality Assurance, and Clinical Research Organizations/external vendors to deliver and drive the completion of all clinical activities on time and within budget.
• Participates in investigator meetings.
• Participates in writing protocols, clinical study reports, and review clinical trial documents.
• Participates in the preparation of key regulatory documents including pre-submission documents and briefings, pre-market and other meetings with the FDA and other regulatory agencies, as needed.
• Participates in the preparation of study budgets; negotiation of contracts and vendors; supports invoice review through payment.
• Oversees vendors in conjunction with study managers to ensure ensuring compliance with all protocol and regulatory requirements using appropriate Quality Assurance procedures