In Clinical Operations Oncology, we work with domestic and international co-development partners and overseas team members to develop clinical development strategies and clinical trial plans. Our team executes clinical trials, collects data, contributes new drug application (NDA), and discusses and obtains approval from regulatory authorities.

We are seeking a new member who is interested in drug development in the oncology field and can take on new challenges while working with overseas members.

This position will assist the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution, and close-out of assigned drug trials.

This position is accountable for supporting the clinical trial team and working collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans.

Essential Job Responsibilities:

We are responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to the trial team and other stakeholders.

We participate in or lead trial-related systems set-up, including implementation and maintenance of appropriate systems, standards, and processes.

We participate in feasibility assessments and select countries and sites for trial conduct.

We manage CRO and vendor set-up and management during clinical trial execution.

We ensure quality and completeness of TMF for assigned clinical trials.

Qualifications:

We require a BA/BS degree in a relevant field, with at least 5 years of clinical trial experience or an advanced degree with at least 3 years of clinical trial experience.

A minimum of 2 years of clinical trial experience in Oncology is required.

We must have strong knowledge of ICH/GCP guidelines and regulatory requirements.

Salary:

$120,000 - $150,000 per year

Work Environment:

This position allows flexible work as determined by the department or division.

We recommend working at the office twice a week.