Clinical Project Scientist

仕事内容

Clinical Project Scientist - 2306141515W

Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Clinical Project Scientist located in Beerse, Belgium. An internal pre-identified candidate has been identified however all applications will be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Clinical Project Scientist works in the Oncology Therapeutic Area Development group, and participates in the development, oversight, and execution of Ph I-IV clinical research trials working closely with Study Responsible Physicians and other Clinical Project Scientists. The position reports to a more senior Clinical Project Scientist.

Essential Functions

• For ongoing clinical trials, this individual in collaboration with the Study Responsible Physician/other Clinical Project Scientists, will participate in or lead aspects of aggregate and participant level data, including patient screening/eligibility evaluation, PK/PD data, adverse events, efficacy, coding, and other data critical to study endpoints
• May participate in drafting protocol synopses, sections of full protocols, informed consent documents, and will review Case Report Forms (CRFs) and other data collection tools against draft protocols and central vendor scope of work
• May partner with the lead Clinical Scientist/Cross Functional Trial Team to mitigate issues in initiation of clinical trials and may participate in review of Monitoring Guidelines, SET/IDMC Charter, Statistical Analysis Plan, Data Management, and Safety Management Plans
• May perform medical monitoring/reporting, evaluates ongoing clinical trial data
• May partner with the lead Clinical Project Scientist drafting Medical Review Plan and Medical Review Forms
• May liaise with vendor laboratories, Translational Research lead, pharmacokinetic operations and/or biomarker operations to ensure sample collection, processing, and tracking
• May liaise with Integrated Data Analysis & Reporting team in set-up of data visualization tools (e.g., iDARTs)
• May participate in or lead aspects of training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study
• May participate in data review and drafting documents for Health Care Authority interactions.
• Will actively participate in mentorship and training opportunities to expand clinical development knowledge, therapeutic area expertise, and leadership capabilities
  

Principal Relationships

Contacts within the Company:

• Members of the Clinical and Cross Functional Trial teams
• Members of Oncology TA
  

Contacts Outside The Company

• May act as a liaison, in partnership with, Study Responsible Physician, Clinical Project Scientist and Global Operations, between company and Investigators, Site Managers, and Site staff, vendor project managers, and CROs
  

Qualifications

Education and Experience:

• Minimum of a bachelor’s degree in a scientific discipline required, with advance degree (i.e., MSc, Ph.D., or Pharm D) preferred
• A minimum of 4 years of experience in a related clinical research position, spending at least part of the time within the pharmaceutical industry, is preferred
  

Required Technical Knowledge And Skills

• Knowledge of scientific research with an understanding of applications to drug development
• 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
• Fluent in written and spoken English with excellent communication skills
• Working knowledge of the use of Microsoft suite of software products
• Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety is preferred
• Ability to travel approximately 10% domestic/international travel may be required
  

The anticipated base pay range for this position is $106,500 to $184,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization Janssen Research & Development, LLC (6084)

Job Function Clinical Research non-MD

Req ID: 2306141515W