Clinical Scientist

KPS Life; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

KPS Life is seeking a Clinical Scientist with oncology experience to lead Phase II-III clinical studies. The role involves strategic design, management, and oversight of global clinical trials, ensuring compliance with regulatory standards. The ideal candidate will have strong analytical and communication skills, with a Bachelor's degree and at least 4 years of relevant experience.

Qualifications

• 4 years of experience in clinical trials/drug development.
• Proficiency in medical writing and knowledge of ICH, GCP guidelines.

Responsibilities

• Design, implement, and analyze clinical studies for Phase II-III.
• Collaborate with teams to ensure compliance with protocols and regulatory requirements.

Skills

Analytical Skills

Communication

Presentation Skills

Medical Terminology

Education

Bachelor's Degree in a relevant scientific discipline

Job description

Join to apply for the Clinical Scientist role at KPS Life.

KPS Life is hiring a Clinical Scientist dedicated to an Oncology-focused client. If you have at least 4 years of experience as a Clinical Scientist in the pharmaceutical industry with oncology experience, please reach out to KPS Life!

The Clinical Trials Scientist functions as an integral member of the Clinical Development and Operations teams to design, implement, and analyze clinical studies. They report to the Lead Clinical Trials Scientist and collaborate with Medical Monitors, Clinical Operations, external vendors, CROs, investigators, and other clinical personnel to lead Phase II-III studies.

Essential Functions

• Focus on strategic design, management, oversight, and execution of global clinical studies (Phase II-III), including clinical strategy, protocol writing, operations, data management, statistical analysis, and reporting.
• Work with Clinical Operations, Regulatory Affairs, Safety, Clinical Supply Chain, Quality Assurance, and external vendors to deliver clinical activities on time and within budget.
• Participate in investigator meetings, protocol and clinical study report writing, and review of clinical trial documents.
• Assist in preparing regulatory documents, including pre-submission documents, briefings, and meetings with agencies like the FDA.
• Contribute to study budgets, vendor negotiations, and invoice reviews.
• Oversee vendors with study managers to ensure compliance with protocols and regulatory requirements using QA procedures.

Professional Qualifications

Minimum Education: Bachelor's Degree in a relevant scientific discipline.

Minimum Experience: 4 years in clinical trials/drug development.

Other Requirements

• Ability to develop and maintain excellent relationships with colleagues and external contacts.
• Proficiency in Medical Terminology and medical writing skills.
• Knowledge of ICH, GCP, and relevant regulatory guidelines.
• Strong analytical, communication, and presentation skills related to clinical data and protocols.
• Experience in a fast-paced, high-growth environment with independence and adaptability.
• Willingness to travel approximately 10%, domestically and internationally.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analysis, Consulting
• Industries: Research Services