Clinical Team Manager - Spanish language & LATAM experience required

Ergomed • Raleigh, NC

7d • Remote

About The Position

The Clinical Team Manager will be responsible for site level operational study management
The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
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
Developing, reviewing and revision of project documents (e.g., clinical monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
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
• Spanish language skillls and experience in LATAM
• A minimum of a science-based bachelor’s degree
• Able to work effectively with minimal supervision

Responsibilities

• site level operational study management
• proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
• 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
• Developing, reviewing and revision of project documents (e.g., clinical monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
• Initiating 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