Clinical Team Manager - Contractor (Spanish Speaking)

Ergomed • Raleigh, NC

1d

About The Position

The Clinical Team Manager will be responsible for operational project management. The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary. This role involves verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments. Additionally, the CTM will be involved in developing, reviewing, and revising project documents (e.g., monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.) and initiating corrective/preventative measures (e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.).

Requirements

• Extensive clinical research lead experience in multiple studies
• Experience in managing Clinical part of studies in more than one region or equivalent study complexities
• Experience of phase 2/3 trials, ideally complex studies such as oncology or rare disease
• Able to work in a fast-paced small CRO environment and manage multiple projects
• A minimum of a science-based bachelor’s degree
• Able to work effectively with minimal supervision
• Spanish Speaking

Responsibilities

• Operational project management
• Proactively identify, resolve/mitigate, and escalate risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
• Verify and ensure that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments
• Develop, review, and revise project documents (e.g., monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
• Initiate corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level