Clinical Scientist

KPS Life; United States; Remote; USD 140,000 - 155,000; Full time

Job summary

KPS Life seeks a Clinical Scientist dedicated to oncology clinical studies. The role involves designing, implementing, and analyzing studies, requiring proficiency in the clinical development process and collaboration with various teams. A bachelor’s degree and four years of experience in drug development are essential. This position is fully remote within the US, offering competitive compensation.

Qualifications

• 4+ years in clinical trials/drug development experience.
• Knowledge of ICH, GCP, and regulatory guidelines.
• Medical writing skills and proficient in Medical Terminology.

Responsibilities

• Design and analyze clinical studies for Phase II-III.
• Collaborate with Clinical Operations and Regulatory Affairs.
• Participate in protocol writing and regulatory document preparation.

Skills

Clinical Development Knowledge

Resilience

Communication

Collaboration

Technical Acumen

Education

Bachelor’s Degree in a relevant scientific discipline

Job description

Join to apply for the Clinical Scientist role at KPS Life

Join to apply for the Clinical Scientist role at KPS Life

Get AI-powered advice on this job and more exclusive features.

KPS Life is seeking a Clinical Scientist to be fully dedicated to one of our oncology focused sponsor clients. If you have experience working as a clinical scientist within the pharmaceutical/drug development industry and have oncology experience, please reach out to us! This role can be remote based anywhere in the US.

Position Summary

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 the Medical Monitors, the Clinical Operations team, along with a variety of external vendors,

clinical research organizations (CROs), clinical investigators, and other clinical personnel to help lead Phase II-III

studies.

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.
  
  

Competencies

The following competencies describe the desired behaviors, skills, and abilities that will facilitate success in this role:

• COMMUNICATION – Expresses ideas clearly and constructively (written and spoken, upward and
  
  

downward, one-on-one and with groups).

• COLLABORATION – Is politically savvy and able to tactfully navigate scientific, procedural, and cultural
  
  

differences and competing concerns to maintain productive relationships to work proactively with others to

streamline work and achieve mutual goals timely.

• CLINICAL DEVELOPMENT KNOWLEDGE – Demonstrates understanding of the required steps to
  
  

progress a new biologic through the stages necessary to allow it to be assessed in human clinical trials;

ability to ensure high quality in the design, development, execution, statistical analysis, clinical interpretation, and reporting of clinical studies.

• PROFESSIONALISM – Treats others with respect; abides by the institutional and cultural values; displays a positive and cooperative attitude; adheres to the standards of conduct and compliance policies. Able to present oneself in a professional manner displaying executive presence, approachability, confidence, and credibility.
• RESILIENCE – Must be resilient and able to manage around constraints and challenges to develop solutions that will involve establishing consensus from parties subject to different international regulatory standards.
• TECHNICAL ACUMEN – Demonstrates a strong understanding of Clinical Operations, key terms, processes, compliance, and timelines as they relate to advancing Biotechnology research through the pre-clinical to clinical phases I-III.
• CULTURAL ACUMEN – Demonstrates understanding of diverse cultures to facilitate and effectively communicate, collaborate, and advance the scientific process in a balanced and compliant manner.
• GOOD CLINICAL PRACTICE (GCP) – 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.
• TEAMWORK –Collaborates effectively with cross-functional teams to achieve project objectives. Contributes positively to team dynamics, fostering a supportive and inclusive work environment. Share knowledge and expertise with team members to enhance collective performance.
• CLINICAL DATA MANAGEMENT – Understands the importance of accurate and reliable clinical data for decision-making. Demonstrates proficiency in data management processes, including collection, cleaning, and analysis. Ensures data integrity and quality through rigorous review and validation procedures.
  
  

Professional Qualifications

Minimum Education

Bachelor’s Degree in a relevant scientific discipline

Minimum Experience

• Four (4) years of experience in clinical trials/drug development
  
  

Other Requirements

• 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Research Services

Referrals increase your chances of interviewing at KPS Life by 2x

Get notified about new Clinical Scientist jobs in United States.

Clinical Scientist, Clinical Development

Waltham, MA $140,000.00-$155,000.00 4 days ago

Associate Director, Pharmacovigilance Scientist - Contract

Medical Science Liaison - Northeast - Hematology/Oncology

United States $130,000.00-$165,000.00 1 week ago

Clinical Genetic Scientist (Genetic Counseling)

Thousand Oaks, CA $60.60-$66.64 2 weeks ago

New York, NY $180,000.00-$195,000.00 1 week ago

Clinical Genomic Scientist II - Exome Analysis (REMOTE:USA)

New York, United States $120,000.00-$145,000.00 1 day ago

Analytical Development Scientist/Senior Scientist

United States $97,600.00-$146,400.00 1 day ago

Medical Science Liaison, US Thoracic Oncology (West)

New Jersey, United States $90.00-$120.00 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.