Note: The job is a remote job and is open to candidates in USA. Johnson & Johnson is a leader in healthcare innovation focused on developing treatments and cures for complex diseases. The Clinical Project Scientist role involves overseeing clinical research trials, developing protocols, and ensuring adherence to clinical guidelines while collaborating with various partners in the oncology field.
Responsibilities
- Partners with Study Responsible Physician (SRP) to provide clinical oversight to the study
- Develops clinical research protocols, study case report forms, informed consent
- Develops the medical review plan to support the statistical analysis plan
- Plays a key role in the medical review of the study data and assists in coding, analysis and documentation
- Validates and interprets results of phase II - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals
- Ensures team member adherence to clinical research guidelines and safety procedures
- Communicates detailed outcomes and results of research findings to relevant partners
- Provides input in managing project budgets and projections
- Serves as liaison to global clinical sites for medical questions related to the clinical research trial
- Presents study status at internal/external meetings, including investigator meetings and governance committees
- Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities
- Participates in/leads interactions with health authorities
- Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
- Reviews and maintains correct standard operations, procedures and protocol
Skills
- A Master's Degree, Ph.D., Pharm.D., or a B.A./B.S. with commensurate exceptional clinical research experience is required
- A minimum of 3 years of industry experience in Oncology
- Significant knowledge of basic and translational research with an understanding of applications to cancer drug development is required
- The ability to work in a matrix team environment and adherence to the highest personal and ethical standards with a commitment to patient-centered clinical research is required
- Clinical Evaluations
- Corrective and Preventive Action (CAPA)
- Drug Discovery Development
- Entrepreneurship
- Good Clinical Practice (GCP)
- Leadership
- Medicines and Device Development and Regulation
- Presentation Design
- Regulatory Affairs Management
- Relationship Building
- Research Documents
- Safety-Oriented
- Scientific Research
- Strategic Change
- Study Management
- Tactical Planning
- Technical Credibility
Benefits
- Annual performance bonus in accordance with the terms of the applicable plan
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Company Overview
Company H1B Sponsorship