Senior Clinical Trial Manager

Clinovo; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Clinovo is seeking an experienced Clinical Trial Manager to oversee end-to-end operations of oncology trials conducted across global sites. The role emphasizes strong vendor management, data cleaning, and closeout activities to ensure timely delivery and regulatory compliance.

The ideal candidate has 5+ years in clinical operations within pharma or CRO settings, with experience spanning start-up to close-out and proficiency in managing budgets and study timelines.

Qualifications

• Bachelor's degree in life sciences or healthcare discipline.
• 5+ years' clinical trial management experience in pharma or CRO.
• Experience from start-up through close-out, including inspection readiness.
• Oncology trials experience preferred.

Responsibilities

• Manage day-to-day operations of assigned trial(s) to meet goals and regulatory requirements.
• Lead cross-functional study teams, including vendors; coordinate with other functions.
• Understand lab sampling practices and lab vendor oversight with cross-functional teams.
• Develop informed consent forms, study training materials, and study tools.
• Provide input into protocol, ICF, CRF design, monitoring conventions, and vendor specs.
• Review and approve key study documents in a timely manner.
• Oversee CROs and third-party vendors to ensure protocol compliance and scope of work.
• Explain study protocol requirements clearly to others.
• Identify risks and develop mitigation strategies with the study team.
• Manage study timeline and provide progress reports to management.
• Maintain tracking for study metrics and data management activities.

Skills

Clinical trial management

Vendor management

Data cleaning

Study closeout

Budget/invoicing

Cross-functional communication

Education

Bachelor’s degree in life sciences or healthcare discipline

Tools

CTMS (Clinical Trial Management System)

GCP/ICH knowledge tools

Job description

100% remote - Have a preference for EST and CST

Misc. Notes:

• Global experience is a plus as they have sites in EU, Australia, and the US (majority of the sites are in the US)
• Must have strong vendor management experience
• Oncology experience is an absolute must
• Must have a strong understanding of study finances
• The primary focus of the role will be supporting an ongoing GVHD study that is under-enrolled in the U.S. The individual will need to lead substantial data cleaning efforts, manage queries, partner closely with Data Management, and drive study closeout and database lock activities.
• The team is seeking someone with hands‑on experience in database lock, study closeout, and CRO management who can operate independently. Prior experience managing strategic partnerships is a plus.
• Due to multiple Study Manager transitions on the Client side, there has been a lack of continuity on the program. The team is looking for an experienced clinical operations professional who can provide stability, partner effectively with Medpace, and ensure seamless execution through study completion so external partners have confidence in the study's leadership and oversight.

The Role:

The CTM is a key contributor to the successful execution of clinical trials, performs a key role in building and maintaining relationships with Investigators and other study site personnel, CRAs, CRO team members, and all external vendors. Based on a thorough understanding of the mechanics of conducting clinical trials, the CTM will closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CRA monitoring activities and vendor management, and will work cross‑functionally to ensure trials are delivered on time, with appropriate quality and within budget.

Key Responsibilities:

• Manage and lead the day‑to‑day operations of assigned trial(s) to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Depending on the scope of assigned trial(s), participate in or manage and lead cross‑functional study teams, including vendors; liaise with other functional areas in order to accurately coordinate clinical study activities.
• Understand lab sampling practices and lab vendor oversight in cooperation with cross‑functional team(s).
• Develop informed consent forms, study training materials, and study tools for assigned trial(s).
• Provide input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications.
• Provide timely review, approval, and sign‑off of key study documents.
• Oversee the performance of CROs and third‑party vendors to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalation to Clinical Operations management.
• Able to understand, interpret, and explain study protocol requirements to others.
• Identify risks and develop mitigation strategies in collaboration with cross‑functional study team.
• Manage study timeline and provide study progress reports to management.
• Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.)
• Basic fiscal awareness (eg, contract, budget, invoicing) and ability to review invoices against statement of work documentation.
• Must have general, functional expertise to support SOP development and implementation.

Desired Experience/Education and Personal Attributes:

• Bachelor’s degree in life sciences or healthcare discipline
• At least 5 years of clinical trial management experience in the pharmaceutical industry or a CRO with progressive responsibilities within operations.
• Must have an understanding of clinical trials from start‑up through close‑out, including experience with Inspection Readiness
• Oncology trials experience is preferred
• Ability to lead effective meetings, demonstrate a good sense of judgment, and ensure cross‑functional communication of important study decisions and milestones
• Working knowledge of GCPs and FDA and ICH regulations and guidelines
• Experience managing external service providers
• Experience with international clinical trials including those run in EU, CA and Australia
• Good understanding of cross‑functional areas including data management/biostatistics, regulatory affairs and pharmacovigilance
• Proven verbal and written communication skills; enjoys interacting with others regularly
• Able to prioritize tasks and work independently
• Able to travel an average of 5-10%, both domestically and internationally