PSI CRO

Clinical Regional Project Lead

Work from home

Remote role where the employee must remain based in a particular country.

Peru only

From the listing details: Source listing states candidate location: "Lima, Callao Region, Peru, Lima, Callao Region, pe, Remote"

Employer listed it 12 days ago · Added 12 days ago

First listed 12 days ago and still open.

Salary

Not stated

Location

Peru only

Timezone

Not stated

Contract

Full-time

Experience

Lead

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 Peru. It is work from home rather than work from anywhere.

What the employer says

Source listing states candidate location: "Lima, Callao Region, Peru, Lima, Callao Region, pe, Remote"

What Nomaders makes of it

Residency required in Peru
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.