Clinical Trial Manager, Oncology
4 weeks ago
Eikon Therapeutics is a biopharmaceutical company that employs revolutionary technology to discover novel treatments for life-threatening diseases. We are seeking a talented and experienced Clinical Trial Manager to join our oncology Clinical Operations team.
About the RoleThis is a dynamic and fast-paced environment where 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.
Key Responsibilities- 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.
- Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions, to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation.
- Collaborate with other Clinical Operations functions 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 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.
- 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.
- 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 $130,000 to $142,500 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.
-
Clinical Trial Manager
1 month ago
Hayward, California, United States BioSpace, Inc. Full timeJob DetailsEikon Therapeutics is a pioneering biopharmaceutical company that leverages cutting-edge technology to develop innovative treatments for life-threatening diseases. Our discovery platform combines chemistry, engineering, computation, and biology to unlock novel drug targets. We are seeking a highly motivated and experienced Clinical Trial Manager...
-
Clinical Trial Manager
4 weeks ago
Hayward, California, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking a highly motivated and experienced Clinical Trial Manager to join our Oncology Clinical Operations team. As a Clinical Trial Manager, 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...
-
Senior Clinical Trial Manager, Oncology
4 weeks ago
Hayward, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly experienced Senior Clinical Trial Manager to lead our global clinical trial operations in Oncology. As a key member of our team, you will be responsible for developing and implementing strategic plans for clinical trials, overseeing all aspects of trial execution, and ensuring compliance with regulatory requirements.Key...
-
Clinical Program Manager
4 weeks ago
Hayward, California, United States BioSpace, Inc. Full timeAbout the RoleThe Clinical Program Manager in Clinical Operations Study Management will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas. This role requires a minimum of 3 days a week of onsite presence in our California, New York, or New Jersey offices to ensure effective management, operational...
-
Senior Biopharma Business Development Manager
4 weeks ago
Hayward, California, United States Predicine, Inc Full timeJob OverviewPredicine, Inc is seeking a highly skilled Senior Biopharma Business Development Manager to join our team. As a key member of our business development team, you will be responsible for growing our BioPharma business and shaping the liquid biopsy industry.Key Responsibilities:Lead large BioPharma accounts to successfully integrate Predicine's...
-
Hayward, California, United States Eikon Therapeutics Full timeAbout the RoleEikon Therapeutics is a pioneering biopharmaceutical company at the forefront of revolutionary technology, combining chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Our discovery platform is built on groundbreaking innovations from our founders, culminating in the creation of...
-
Diagnostic Imaging Specialist
3 weeks ago
Hayward, California, United States US Oncology Network-wide Career Opportunities Full timeJob SummaryUS Oncology Network-wide Career Opportunities invites applications for the position of Diagnostic Imaging Specialist. The selected candidate will perform diagnostic PET/CT and CT imaging procedures, collaborate with Medical Director and Supervisor on technical issues, and support the US Oncology Compliance Program.Key ResponsibilitiesPerform...
-
Regional Nurse Manager
1 month ago
Hayward, California, United States Soleo Health Full timeJob Title: Regional Nurse ManagerSoleo Health is seeking a highly skilled Regional Nurse Manager to oversee the administration of nursing services in the Hayward, CA area. As a key member of our team, you will be responsible for directing, planning, and coordinating the service activities and staffing performance of professional nursing and auxiliary nursing...
-
Hayward, California, United States Arcus Biosciences Full timeJob SummaryWe are seeking an experienced Associate Director to join our Outsourcing and Vendor Governance team at Arcus Biosciences. As a key member of our team, you will be responsible for managing and optimizing Vendor Engagement, supporting outsourcing needs for current and future clinical trials, and collaborating with internal stakeholders to resolve...
-
Process Management Director
4 weeks ago
Hayward, California, United States Eikon Therapeutics Full timeAbout the RoleWe are seeking a highly skilled Associate Director, Process Management to join our Clinical Research & Development team at Eikon Therapeutics. This dynamic and strategic role will focus on creating and driving business process optimization and continuous improvement to support the growth and organizational effectiveness of our team.Key...
-
Clinical Research and Development Manager
4 weeks ago
Hayward, California, United States Eikon Therapeutics Full timeEikon Therapeutics is a pioneering biopharmaceutical company that leverages cutting-edge technology to develop novel treatments for life-threatening diseases. Our discovery platform combines chemistry, engineering, computation, and biology to unlock previously inaccessible classes of proteins as drug targets.Job SummaryWe are seeking a highly skilled...
-
Outpatient Clinical Manager
4 weeks ago
Hayward, California, United States ColumbiaCare Services Full timeAbout the JobWe are seeking a highly skilled Outpatient Clinical Manager to join our team at ColumbiaCare Services. As a Clinical Supervisor, you will provide clinical supervision to our Outpatient Services' Qualified Mental Health Professional (QMHP) and Qualified Mental Health Associate (QMHA) staff.The ideal candidate will have a Master's Degree in...
-
Clinical Nurse Specialist
3 weeks ago
Hayward, California, United States Neogen Care Full timeAbout This RoleNeogen Care is a leading provider of medical and non-medical home care services in the California Bay Area. We are seeking a highly skilled Registered Nurse to join our team of clinical professionals.Job SummaryThe successful candidate will provide direct patient care in the patient's home under the supervision of a physician. Responsibilities...
-
Physical Therapy Clinic Director
4 weeks ago
Hayward, California, United States Next Move Healthcare Full timeJob Title: Physical Therapy Clinic DirectorLocation: Hayward, CaliforniaShift: Monday to Friday, 8:00 AM - 5:00 PMShifts Per Week: 5Scheduled Hours: 40 hours per weekSalary Range: $90,000 - $115,000 annuallyBonuses:Up to $20,000 for relocation, sign-on bonuses, and/or student loan assistanceCenter Managers can earn an annual bonus of up to 8% of yearly...
-
Clinical Program Director
4 weeks ago
Hayward, California, United States Tiburcio Vasquez Health Center Full timeJob Title: Clinical Program DirectorTiburcio Vasquez Health Center is seeking a highly skilled Clinical Program Director to lead our New Graduate NP/PA Training Program. As a key member of our leadership team, you will be responsible for implementing and overseeing the program's clinical services, ensuring high-quality patient care and exceptional patient...
-
Hayward, California, United States Arcus Biosciences Full timeJob SummaryWe are seeking a highly experienced Associate Director, Outsourcing and Vendor Governance to join our team at Arcus Biosciences. As a key member of our Clinical Operations department, you will be responsible for managing and optimizing Vendor Engagement, ensuring seamless collaboration with internal stakeholders and service providers.Key...
-
Chiropractic Clinic Coordinator
4 weeks ago
Hayward, California, United States The Joint Chiropractic Full timeJob OverviewThe Joint Chiropractic is seeking a highly motivated and customer-focused individual to join our team as a Wellness Coordinator. As a key member of our clinic staff, you will play a vital role in delivering exceptional patient experiences and promoting our chiropractic services.Key Responsibilities:Provide exceptional patient care and support,...
-
Regional Nursing Director
4 weeks ago
Hayward, California, United States Soleo Health Full timeJob Summary:Soleo Health is seeking a skilled Regional Nurse Manager to oversee the administration of nursing services within our region. As a key member of our team, you will be responsible for directing, planning, and coordinating the service activities and staffing performance of professional nursing and auxiliary nursing personnel.Key...
-
Clinical Nurse Specialist
1 month ago
Hayward, California, United States Neogen Care Full timeJob OverviewNeogen Care is seeking a highly skilled and compassionate Home Health Registered Nurse to join our team. As a key member of our clinical staff, you will provide high-quality patient care in the comfort of patients' homes, working collaboratively with our multidisciplinary team to achieve positive patient outcomes.Key Responsibilities:Conduct...
-
Regional Clinical Liaison
4 weeks ago
Hayward, California, United States Skilled Wound Care Full timeWe are seeking a highly motivated and experienced RN/LVN to join our team as a Regional Clinical Liaison. In this role, you will be responsible for developing and managing clinical accounts throughout multiple regions in the United States.As a Regional Clinical Liaison, you will work closely with our physician development team to ensure that our providers...
