Senior Clinical Trial Manager, Oncology
About The Position
As a Senior Clinical Trial Manager, you will play a pivotal role in leading and overseeing our global clinical trial operations. Operating in a dynamic and collaborative environment, you will provide strategic direction and hands-on management to ensure the successful execution of global clinical trials in multiple regions, contributing to the development of groundbreaking therapies with the potential to transform patient lives. The successful candidate will need minimal oversight, will work closely with cross-functional teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support excellence and world class clinical study management. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, NJ or Millbrae, CA offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
Requirements
- Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline).
- Substantial experience in clinical trial management, including leadership roles.
- 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.
Responsibilities
- 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
- Lead and mentor a team of clinical trial associates, coordinators, and specialists, fostering a high-performing and collaborative work environment.
- 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, EMEA, PMDA and other relevant regulations and guidelines.
- Manage and maintain accurate and up-to-date trial documentation, ensuring compliance with regulatory requirements and industry standards.
- Collaborate with recruitment teams to optimize patient recruitment strategies and ensure the timely enrollment of eligible study participants.
- Oversee data collection, entry, and validation processes to maintain the integrity of clinical trial data.
- Foster effective communication and collaboration among cross-functional teams, including investigators, study coordinators, vendors, and other stakeholders.
- Implement and oversee quality control processes to maintain the highest standards of data accuracy and trial conduct.
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
