Pfm
Senior Clinical Trial Manager (LATAM)
Remote, Brazil; Remote, Colombia; Remote, Mexico. Posted a month ago
The role
The Senior Clinical Trial Manager will lead clinical operations across Latin America. This person will own the planning, execution, and oversight of clinical studies while serving as the primary client contact.
What you will do
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents
- Identify and develop training needs for CRAs and third-party vendors
- Generate potential site list and drive site feasibility process
- Identify potential risks to enrollment targets
- Develop and finalize the country recruitment/retention strategy
- Lead internal clinical team meetings
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees
- Develop clinical monitoring strategies
Required qualifications
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field
- Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
- Professional working proficiency in English
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
- Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance
- Working knowledge of clinical management techniques and tools
- Direct work experience in a cross-functional environment
- Proven experience in functional management including proven experience in delegating
- Proven experience in planning, risk management and change management
Nice to have
- Advanced degree
Before you apply
- Candidates must be legally authorized to work in the country of employment without employer sponsorship
About the company
pfm is building and leading expanding clinical operations across Latin America.