Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
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 onsite presence a minimum of 3 days a week to ensure effective management of assigned Phase I-III in-sourced global clinical studies.
About You
You are a talented, experienced, growth minded individual and have a passion for excellence in advancing patient care and driving strategic operating priorities to advance patient care in Oncology or other therapeutic areas.
What You'll Do
- 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, EMEA, PMDA and other relevant 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.
Qualifications
- 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.
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 $156,750 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
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