We have an excellent job opportunity available as a Study Responsible Scientist!
Our role is expected to last 12 months
Responsibilities of the Study Responsible Scientist:
Partner with Study Responsible Physician (SRP) to provide clinical oversight to the study
Develop clinical research protocols, study case report forms, informed consent
Develop the medical review plan to support the statistical analysis plan
Play a key role in the medical review of the study data and assist in coding, analysis, and documentation
Validate and interpret results of phase I - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals
Ensure team member adherence to clinical research guidelines and safety procedures
Communicate detailed outcomes and results of research findings to relevant partners
Provide input in managing project budgets and projections
Serve as liaison to global clinical sites for medical questions related to the clinical research trial
Present study status at internal/external meetings, including investigator meetings and goverance committees
Train and mentor 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
Participate in/leads interactions with health authorities
Maintain expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies
Review and maintain correct standard operations, procedures, and protocol
Requirements of the Study Responsible Scientist:
A minimum of a bachelor's degree is required; and advanced degree is preferred
A minimum of 3 years of clinical research and development, or related experience within the industry (pharmaceutical, biotech, CRO, etc) is required
Oncology experience is a must for this position
Ability to problem solve, work independently and drive solutions are imperative
Effective communication skills.
Hands on project coordination experience.
Consensus building, meeting facilitation, deliverable follow up, etc.
Communicate and present at the executive level: proficiency in stakeholder buy in, strong cross functional communication, organizational navigation, building rapport across functions and levels of management
Experience in oncology therapeutic area is preferred
Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred
Excellent written communication, oral communication, and presentation skills are required
The individual must have demonstrated ability to work in a team environment
Ability to travel up to 10% required
Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an eglifesciences.com email address and never provide personal or financial information to anyone who is not clearly associated with EG Life Sciences. If you have any indication of fraudulent activity, please contact
Job ID: 375341
About EG Life Sciences:
Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.
Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
