Lead Clinical Research Manager (Hybrid/Remote)

MedXCRO; Toledo (OH); Hybrid; USD 75,000 - 95,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Med X CRO in Toledo, Ohio, seeks a Lead Clinical Research Manager to oversee operational execution of clinical trials from startup through closeout. This hybrid role requires you to coordinate sponsors, sites, vendors, and internal teams, ensuring studies comply with regulations and SOPs while driving timelines and deliverables.

You will mentor CRAs and CTAs, manage budgets, and support study startup, monitoring, and closeout activities across phases, balancing speed with quality in a dynamic

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred.
• Minimum 5 years of clinical trial management experience within CRO/pharma/biotech.
• Experience managing full-cycle clinical trials.
• Strong knowledge of GCP, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312) and ICH guidelines.
• Experience managing sponsor relationships and vendor oversight.
• Proficiency with eTMF systems, EDC platforms, and clinical project management tools.
• Excellent communication, leadership, and organizational skills.
• Ability to manage multiple studies and priorities in a fast-moving environment.
• Primarily remote role with occasional travel to investigational sites, sponsor offices, or company locations

Responsibilities

• Develop and maintain study timelines, trackers, and project plans.
• Ensure protocol, GCP, FDA compliance and SOP adherence.
• Identify operational risks and implement mitigations.
• Monitor study progress, enrollment, and site performance.
• Lead study team meetings and sponsor calls.
• Oversee site management and monitoring activities.
• Coordinate external vendors and maintain sponsor communication.
• Support site startup activities including regulatory collection.
• Maintain TMF/eTMF documentation.

Skills

GCP knowledge

FDA regulations

Project management

Vendor oversight

Communication

Leadership

Time management

Remote work

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

eTMF

EDC platforms

Clinical PM tools

Job description

Med X CRO in Toledo, Ohio, seeks a Lead Clinical Research Manager to oversee operational execution of clinical trials from startup through closeout. This hybrid role requires you to coordinate sponsors, sites, vendors, and internal teams, ensuring studies comply with regulations and SOPs while driving timelines and deliverables.

You will mentor CRAs and CTAs, manage budgets, and support study startup, monitoring, and closeout activities across phases, balancing speed with quality in a dynamic