Eikon Therapeutics - Senior Clinical Trial Manager, Oncology (APAC)

Jersey City, NJ; Millbrae, CA$143k - $173k+ Equity3w ago

In Office Senior NA Insurance Clinical Research Clinical Director Senior Community Manager Microsoft Office Team Management Clinical Trials Team Leadership Documentation

Requirements

• Substantial experience in clinical trial management, including leadership roles. • Require direct working experience with APAC countries, trial conduct experience in Japan and/or China, preferred. • Strong organizational skills with meticulous attention to detail. • Exceptional communication and leadership capabilities. • Proficiency in Microsoft Office Suite and clinical trial management software. • Ability to thrive in a fast-paced and evolving work environment. • In-depth knowledge of clinical trial processes, regulations, and industry best practices, especially for APAC countries. • Proficiency in Asian language (Chinese, Japanese, or Korean) in speaking, and require strong English skill (reading, writing, and speaking with an ability to effectively communicate with colleagues and stakeholders at all levels), highly preferred. • At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: • 401k plan with company matching • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) • Mental health and wellness benefits • Weeklong summer and winter holiday shutdowns • Generous paid time off and holiday policies • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies • Enhanced parental leave benefit • Daily subsidized lunch program when on-site • The expected salary range for this role is $143,000 to $173,250 depending on skills, competency, and the market demand for your expertise.

Responsibilities

• Trial Strategy and Oversight: Develop and implement strategic plans for clinical trials, overseeing all aspects of trial execution, including planning, monitoring, and closeout. • Oversight and coordination of local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention. requirements (in collaboration with TMF Operations team), insurance process management. • Team Leadership: Lead and mentor a team of clinical trial associates, coordinators, and specialists, fostering a high-performing and collaborative work environment. • Regulatory Compliance: Ensure strict adherence to relevant regulations, protocols, and standard operating procedures (SOPs), and keep abreast of changes in regulatory requirements. Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP and relevant country regulations and guidelines. • Trial Documentation: Manage and maintain accurate and up-to-date trial documentation, ensuring compliance with regulatory requirements and industry standards. • Patient Recruitment: Collaborate with recruitment teams to optimize patient recruitment strategies and ensure the timely enrollment of eligible study participants. • Data Management: Oversee data collection, entry, and validation processes to maintain the integrity of clinical trial data. • Cross-functional Collaboration: Foster effective communication and collaboration among cross-functional teams, including investigators, study coordinators, vendors, and other stakeholders. • Quality Assurance: Implement and oversee quality control processes to maintain the highest standards of data accuracy and trial conduct. • Budget and Resource Management: Manage trial budgets and allocate resources effectively to ensure trial success within financial constraints. • Enter and update country information in clinical, regulatory, safety and finance systems. • Contribute or lead initiatives and projects adding value to the enterprise, as required.

Benefits

• Weeklong summer and winter holiday shutdowns • Generous paid time off and holiday policies • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies • Enhanced parental leave benefit • Daily subsidized lunch program when on-site • The expected salary range for this role is $143,000 to $173,250 depending on skills, competency, and the market demand for your expertise.