CLINICAL PROJECT SCIENTIST, ONCOLOGY

At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.
nj.
om/.
Johnson & Johnson is recruiting for a Clinical Project Scientist, Oncology.
The position can be located in Spring House, PA; Raritan, NJ; High Wycombe, UK; Beerse, Belgium; Breda, Netherlands; or Issy-les-Moulineaux, France.
Remote work options within the United States, United Kingdom and European Union may be considered on a case-by-case basis and if approved by the company.
The Clinical Project Scientist (CPS) 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.
Primary Responsibilities Include.
·        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 CPS/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 CPS 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.
., 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 Qualifications ·        Minimum of a bachelor’s degree in a scientific discipline required, with advance degree (i.
., MSc, Ph.
., 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.
·        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.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.  This job posting is anticipated to close on April . The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.