Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - Non-MD
Job Category:Scientific/Technology
All Job Posting Locations:Raritan, New Jersey, United States of America
Job Description:The Clinical Project Scientist is responsible for the design, planning, implementation, monitoring, and reporting of clinical research trials.
The following responsibilities will be demonstrated in varying degrees of participation and leadership:
- 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
Required Skills: Preferred Skills: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
