Clinical Trial Manager, Oncology

Eikon Therapeutics; New York (NY); On-site; USD 130,000 - 143,000; Full time

Job summary

An established industry player is looking for a Clinical Trial Manager to lead oncology clinical studies. In this dynamic role, you will ensure compliance with regulatory guidelines while managing all aspects of clinical trials from start to finish. You will collaborate with cross-functional teams to deliver high-quality data on time and within budget. This position offers the opportunity to make a significant impact on patient care for grievous diseases while working in a supportive and innovative environment. If you have a passion for clinical excellence and a desire to advance your career, this is the perfect opportunity for you.

Benefits

401k plan with company matching

Medical, dental, and vision insurance

Mental health and wellness benefits

Paid time off and holiday policies

Enhanced parental leave benefit

Daily subsidized lunch program

Weeklong summer and winter holiday shutdowns

Life/AD&D Insurance

Qualifications

• 3+ years of clinical trial management experience in oncology.
• Strong knowledge of ICH-GCP and FDA regulations.
• Proven ability to lead and collaborate with cross-functional teams.

Responsibilities

• Oversee the management of international clinical trials, ensuring quality and compliance.
• Collaborate with teams to develop operational plans and manage trial activities.
• Monitor study progress and implement corrective actions as necessary.

Skills

Clinical Trial Management

Project Management

Communication Skills

Analytical Skills

Problem-Solving

Collaboration

Education

PhD in Life Sciences

Master’s Degree in Life Sciences

Bachelor’s Degree in Life Sciences

Tools

Veeva CTMS

Job description

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 a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California, New York or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

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

1. 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.
2. Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials.
3. 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.
4. Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation.
5. Collaborate with other Clinical Operations functions (Site Engagement & 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.
6. Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention.
7. Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines.
8. Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle.
9. As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial.
10. 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).
11. Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements.
12. Lead the creation and maintenance of all study files, including the study master file, and oversight of site files.
13. Lead periodic review of the Sponsor Trial Master File.

Qualifications

1. 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).
2. In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research.
3. Demonstrated experience in managing and executing clinical trials from start-up to closeout.
4. Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets.
5. 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.
6. Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations.
7. Proficiency in using Veeva clinical trial management systems (CTMS).
8. 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:

1. 401k plan with company matching.
2. Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%).
3. Mental health and wellness benefits.
4. Weeklong summer and winter holiday shutdowns.
5. Generous paid time off and holiday policies.
6. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies.
7. Enhanced parental leave benefit.
8. 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.