Category: Scientific & Clinical
LOCATION: Florham Park, NJ. Will start out remote but will eventually be office-based. Not considering 100% remote candidates at this time
- BA/BS; Life Science degree a plus or higher degree
- Work experience to include a minimum of 8-10 years’ industry oncology clinical trial experience (at least 5 years as a study lead) with a solid understanding of functional area responsibilities associated with the clinical development process
- Minimum 2 years of direct supervisory experience
- Strong working knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Must have strong project management, communication (oral and written), and analytical skills
- Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required
- Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment
- Must be able to travel
As a key member of the Clinical Operations team, successful candidate will work closely with the Executive Director/Vice President of Clinical Operations and will be responsible for leading the activities in the preparation, implementation, and completion of various clinical trials in accordance with the Clinical Development Plan.
This position also provides an opportunity to join a growing development organization and contribute substantially to how the company will operationalize oncology trials in the future, while expanding internationally. In addition, there is an opportunity to expand your knowledge in the scientific and research aspects in oncology across multiple areas working on several assets, through day-to-day activities and close interactions with the Research and Discovery teams within COMPANY (US) and teams in Shanghai, China
MAJOR RESPONSIBILITIES AND DUTIES
- Represent COMPANY (US) Inc in front of our sites and investigators, in close collaboration with our CRO partners
- Develop and drive study timelines and study plans and its execution
- Responsible for vendor oversight (CRO, central lab, specialty vendors, etc.)
- Responsible for managing approved trial budget(s)
- Develops and oversees study operational plan(s)
- Interface with the CRO regarding follow-up of status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities)
- Proactively identifies project risks and resolves with some supervision, as needed
- Review and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure.
- Maintain and ensure the quality and completeness of study master files across programs in compliance with GCP
- Represent Clinical Operations in cross-functional initiatives – work closely with clinical development, discovery, translational and pre-clinical research colleagues.
MAJOR SECONDARY RESPONSIBILITIES AND DUTIES
- Prepare QC plan based on designed project;
- Conduct co monitoring visits based on trial status;
- Develop CAPA according to identified issue.