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Clinical Trial Manager, Oncology
4 months ago
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
We are seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. The candidate must have the ability to work independently, be an effective leader, and an engaged clinical study team member in a dynamic, fast-paced environment. You will play a key role in contributing to high quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and the successful completion of global clinical studies. This role will require onsite presence a minimum of 3 days a week to ensure effective management of assigned Phase I-III insourced global clinical studies.
About You
You have strong communication skills and are a collaborative, agile, detail oriented trial leader with global trial experience, and you have a passion for operational excellence and advancing patient care for grievous diseases.
What You'll Do
* In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, delivering high quality study data, on time and on budget
* Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials
* Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective.
* Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagment & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation
* Collaborate with other Clinical Operations functions (Site Engagment & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines
* Collaborate with other Clinical Operations functions (Site Engagment & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention
* Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines
* Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle
* As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial
* Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs)
* Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements
* Lead the creation and maintenance of all study files, including the study master file, and oversight of site files
* Lead periodic review of the Sponsor Trial Master File.
Qualifications
* PhD with 3 years of experience; or a Master's Degree with 6 years of relevant experience or a Bachelor's degree with 8 years of relevant experience in a relevant field (e.g., life sciences, healthcare, or related discipline).
* In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research
* Demonstrated experience in managing and executing clinical trials from start-up to closeout
* Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets
* Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary
* Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations
* Proficiency in using Veeva clinical trial management systems (CTMS)
* Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology.
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 $139,000 to $152,000 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.
In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
