Clinical Operations Lead (Oncology)

Everest Clinical Research Corporation; Northern (KY); Hybrid; USD 135,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid time off

Tuition reimbursement

Wellness reimbursement

Job summary

Everest Clinical Research is seeking a Clinical Operations Lead for an on-site (Bridgewater, NJ) or remote work arrangement in the USA. The role focuses on leading site management and monitoring to ensure quality deliverables, timelines, and budget adherence across clinical studies.

Ideal candidates will have 7+ years in clinical research, strong ICH-GCP knowledge, oncology/pain therapy experience, and ability to mentor a diverse operations team while traveling ~25%.

Qualifications

• Bachelor’s degree or RN in life sciences or related field.
• Seven (7) years’ clinical research trial and/or monitoring experience.
• Thorough knowledge of ICH‑GCP guidelines and applicable regulations.
• Experience conducting clinical trials in Pain therapeutic area (acute and chronic).
• Flexible and resilient in evolving environments.
• Oncology experience required; Pain/CV/Metabolic experience advantageous.

Responsibilities

• Provide leadership and strategic planning for assigned clinical studies through all phases.
• Drive site identification, initiation, and motivation for patient recruitment/retention.
• Ensure high-quality deliverables via CTMS/eTMF and tracking tools.
• Oversee CTMS and TMF set‑up and maintenance; quality control reviews.
• Conduct training for the study team on project matters and therapeutic areas.
• Support site contracts/budgets preparation and vendor payments.
• Prepare and submit regulatory documents to authorities and IRBs.

Skills

Leadership

Clinical Trials

ICH-GCP

Site Monitoring

Regulatory Compliance

Travel

Mentoring

Education

Bachelor's degree or RN

Job description

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team asClinical Operations Leadfor our Bridgewater, New Jersey, USA on‑site location, or remotely from a home‑based office anywhere in the USA in accordance with our Work from Home policy.

The Clinical Operations Lead will serve as the clinical functional lead, accountable for the site management/clinical monitoring delivery of assigned tasks and project(s) as per scope. The position will provide leadership, mentoring, and technical support to the Clinical Operations team to ensure quality deliverables and achievement of milestones and financial goals. The Clinical Operations Lead is responsible for tracking study progress and assessing compliance of the conduct of clinical trials with regulatory requirements, the clinical study protocol, study‑specific plans, and Standard Operating Procedures.

Key Accountabilities:

• Provide leadership, local/global strategic planning and operational delivery of assigned clinical studies/program through all phases of study management (study start‑up, conduct/maintenance, closure), in accordance with Everest quality standards, all applicable regulations, timelines and budget commitments.
• Ensure the effective identification, initiation and motivation (patient recruitment/retention) of clinical study sites.
• Focus on internal and external customers service (Sponsors, study sites, vendors) related to site management and clinical monitoring activities to ensure timely and high quality deliverables through CTMS/eTMF and/or tracking tools.
• Provide oversight and quality control review for set‑up and maintenance of studies in Clinical Trial Management System (CTMS) and Trial Master File (TMF).
• Plan and conduct initial and ongoing training for the study team on project‑specific matters and enlists therapeutic assistance where applicable.
• Drive the successful activation of trial sites according to time, quality/scope and budget parameters.
• Serve as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required.
• Develop a monitoring plan as well as monitoring tools.
• Oversee the preparation, conduct and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues. May conduct monitoring visits as necessary.
• Collaborate with other functional departments to identify issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk.
• Assist functional clinical operations delivery team.
• Assist with the preparation and negotiation of sites contracts/budgets and prepare payments for vendors/study sites.
• Assist with preparation and submission of regulatory documents to responsible regulatory agencies, authorities, IRBs and/or Research Ethics Committees.
• Develop and/or review information provided to study subjects, i.e., informed consent forms.
• Monitoring the quality of clinical deliverables and addresses quality issues with the appropriate team member.
• Perform COL II responsibilities as needed.

Qualifications and Experience:

• Bachelor’s degree or RN in a life science or related field of study.
• Seven (7) years’ clinical research trial and/or monitoring experience.
• Thorough knowledge of ICH‑GCP guidelines and applicable regulations.
• Demonstrated experience conducting clinical trials within the Pain therapeutic area (acute and chronic).
• Works in an environment that is constantly evolving with new processes and systems. Flexible and resilient with ability to evolve in changing and challenging environment.
• Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team, and organizational objectives.
• Oncology experience required. Pain / CV / and Metabolic experience would be advantageous.
• Thorough comprehension of medical terminology and project financial principles.
• Moderate travel may be required, approximately 25%.
• Must maintain a valid driver’s license and be able to drive to monitor sites.

Benefits & Compensation:

We offer a robust benefits package to support your health, well‑being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short‑and long‑term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement / pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com

Estimated Salary Range: $135,000 - 160,000.

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.