PSI CRO
More roles at PSI CROClinical Regional Project Lead
Remote role where the employee must remain based in a particular country.
Chile only
From the listing details: Source listing states candidate location: "Santiago, Santiago Metropolitan Region, Chile, Santiago, Santiago Metropolitan Region, cl, Remote"
Employer listed it 12 days ago · Added 12 days ago
First listed 12 days ago and still open.
Salary
Not stated
Location
Chile only
Timezone
Not stated
Contract
Full-time
Experience
Lead
Category
Other
The employer did not publish a salary, and we have too few comparable roles to estimate one.
What the advert says
Quoted word for word from the employer's advert. Where it says nothing, we say so.
- Working hours
- Not mentioned in the advert
- Where you can work from
Prior experience in Clinical Research and on-site monitoring is required
- Contract
- Not mentioned in the advert
- Experience asked for
- Not mentioned in the advert
- Pay
- Not mentioned in the advert
Remote flexibility
Work from home
This is a remote role, but the employee must be based in Chile. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Santiago, Santiago Metropolitan Region, Chile, Santiago, Santiago Metropolitan Region, cl, Remote"
What Nomaders makes of it
- Residency required in Chile
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
Before you apply
Experience: employer states
Written as a requirement
- “College/University degree in Life Sciences or an equivalent combination of education, training & experience is required”
- “Prior experience in Clinical Research and on-site monitoring is required”
Written as a nice-to-have
- “Experience in GI is preferred ”
Questions worth asking: Nomaders interpretation
- No pay is stated. Ask for the salary range before investing time in interviews.
- The advert does not say whether this is employment or a contractor arrangement. Ask, as it affects tax and benefits.
Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.
About the role
PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.
The Regional Project Lead is a senior level clinical trial manager who oversees, manages, and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level.
Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)
Acts as primary or secondary project management contact for the project team and PSI support services in designated countries
Performs study status review and progress reporting (if delegated by the Project Manager)
Collects and reports project status updates for designated regions, both internally and externally
Develops and updates project planning documents, essential study documents and project manuals/ instructions
Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members
Ensures that the project timelines and subject enrollment targets are met in designated countries
Coordinates maintenance of study-specific and corporate tracking systems
Coordinates site contractual startup and budget negotiations
Establishes communication lines within the project team and supervises clinical project team members’ performance
Identifies, escalates and resolves resourcing and performance issues
Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)
Prepares presentations and conducts training of Investigators
Ensures team compliance with project-specific training matrix
Performs field training of Monitors tailored to the project needs
Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings
Coordinates conduct of supervised monitoring visits
Reviews site visit reports and ensures monitoring and reporting standards are met 
Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
Oversees the safety information flow and participates in feasibility research
Requirements
- ·Ability to negotiate and build relationships at all levels
- ·Team building, leadership and organizational skills
- ·Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.
Benefits
No benefits package published with this listing. Ask about it at first interview.
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at PSI CRO, mentioning your remote working experience.
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 13d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
Pay not stated · You'll be taken to the employer's careers page.