Clinical Trial Leader Job

CLINICAL TRIAL LEADER needed for a CONTRACT opportunity with Yoh's client located in East Hanover, NJ.

Top Skills You Should Possess:
- Good GCP knowledge
- Basic understanding of oncology and/or hematology
- Early Clinical Development experience
- Publishing Clinical Studies

What You'll Be Doing:
- Accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials.
- Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.
- Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
- Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget
- Sits on Early Program Team (EPT) to contribute to program strategy.
- Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties

What You Need to Bring to the Table:
- Four (4) or more years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
- Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
- Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred.
- Hands-on experience in data cleaning and analysis recommended.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kara Lloyd

WHAT ARE YOU WAITING FOR? APPLY NOW!

Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.

J2W: CLINICAL

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