Associate Director of Clinical Development
il y a 7 jours
Johson & Johnson is a global healthcare leader that delivers innovative medical solutions to transform the lives of people around the world. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured.
Job Summary:
The Clinical Project Scientist will work in the Oncology Therapeutic Area Development group and will actively participate and may lead aspects of the development, oversight, and execution of Ph I-IV clinical research trials working closely with Study Responsible Physicians, Clinical Leaders, and other Clinical Project Scientists.
Key Responsibilities:
- In collaboration with the Study Responsible Physician and Clinical Leader, will actively participate in or lead aspects of medical review of clinical trial data, including adverse events, efficacy data, patient screening/eligibility evaluation, PK/PD data, coding, and other data critical to study endpoints.
- Participate or may lead drafting protocol synopsis, sections of full protocols, informed consent documents, review, and development of Case Report Forms (eCRFs), and other data collection tools against draft protocols and central vendor scope of work.
- Partner or lead Cross Functional Trial Team to mitigate issues in initiation and management of one or more clinical trials and participate in review of Monitoring Guidelines, SET/IDMC charter, Statistical Analysis Plan, Data Management, and Safety Management Plans.
Requirements:
- High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to oncology clinical research and the highest personal and ethical standards.
- Successful work experience in a matrix team environment with global cross-functional teams is required.
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