Regional Project Lead
About the role
with. Then "Job Duties Include:" followed by a long list of duties (sentences separated by no punctuation? Actually they are concatenated with no spaces? Let's parse: "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 countriesPerforms study status review and progress reporting (if delegated by the Project Manager)Collects and reports project status updates for designated regions, both internally and externallyDevelops and updates project planning documents, essential study documents and project manuals/ instructionsManages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team membersEnsures that the project timelines and subject enrollment targets are met in designated countriesCoordinates maintenance of study-specific and corporate tracking systemsCoordinates site contractual startup and budget negotiationsEstablishes communication lines within the project team and supervises clinical project team members’ performanceIdentifies, escalates and resolves resourcing and performance issuesConducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)Prepares presentations and conducts training of InvestigatorsEnsures team compliance with project-specific training matrixPerforms field training of Monitors tailored to the project needsSupervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visitsOversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution processSupervises project team preparation for study audits/ inspections and resolution of audit/ inspection findingsCoordinates conduct of supervised monitoring visitsReviews site visit reports and ensures monitoring and reporting standards are met Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notificationsOversees the safety information flow and participates in feasibility researchReviews/approves project related expenses and timesheets (if delegated by the Project Manager)". This is a long paragraph with no separators. We need to turn into
- items. We need to split each duty. Likely each sentence starts with a verb. We can split at each capital letter after a period? But there are no periods. We need to infer boundaries: after each closing parenthesis maybe? Let's manually split by looking at phrases:
- 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
- Reviews/approves project related expenses and timesheets (if delegated by the Project Manager)
That seems correct.
Now Qualifications section: after duties we have "Qualifications College/University degree in Life Sciences or an equivalent combination of education, training & experience is requiredPrior experience in Clinical Research and independent on-site monitoring is requiredExperience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is requiredTherapeutic expertise in Oncology and/or Gastroenterology requiredFull working proficiency in EnglishProficiency in MS Office applications, including MS ProjectCommunication, presentation and customer-service skillsAbility to negotiate and build relationships at all levelsTeam building, leadership and organizational skills"
We need to split into list items. Likely each sentence separated by missing spaces. Let's split:
- College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
- Prior experience in Clinical Research and independent on-site monitoring is required
- Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required
- Therapeutic expertise in Oncology and/or Gastroenterology required
- Full working proficiency in English
- Proficiency in MS Office applications, including MS Project
- Communication, presentation and customer-service skills
- Ability to negotiate and build relationships at all levels
- Team building, leadership and organizational skills
Now after that: "For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future." That's a note about visa restriction. Could be part of Requirements? Might be a requirement. We'll include as a bullet under Requirements or Qualifications? Probably under Requirements (or Qualifications). Since it's a restriction, we can put under Requirements as a bullet.
Then "Additional Information Why Join PSI? At PSI, you'll join a privately owned, global CRO with over 30 years of steady growth. Unlike many organizations in our industry, we've remained independent, have never experienced layoffs, and continue to invest in our people. Here you'll find: Opportunities to lead complex global studiesA collaborative, people-first cultureCareer growth and professional developmentFlexible working arrangementsA stable organization where long-term careers are builtMeaningful work that helps bring innovative therapies to patients around the world"
We need to parse that into Benefits maybe. The list after colon: "Opportunities to lead complex global studiesA collaborative, people-first cultureCareer growth and professional developmentFlexible working arrangementsA stable organization where long-term careers are builtMeaningful work that helps bring innovative therapies to patients around the world"
Split:
- Opportunities to lead complex global studies
- A collaborative, people-first culture
- Career growth and professional development
- Flexible working arrangements
- A stable organization where long-term careers are built
- Meaningful work that helps bring innovative therapies to patients around the world
These are benefits. So we can create a Benefits section with ul.
No explicit Pay or Schedule info. So we omit those sections.
Now we need to output HTML fragment with headings
and appropriate
or
- .
We need to include About the role (p), Responsibilities (ul), Requirements (maybe combine qualifications and visa note?), Qualifications (maybe separate?), Skills (maybe combine communication etc?), Benefits (ul). The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should follow those headings exactly if content exists.
We have content for About the role, Responsibilities, Requirements (maybe visa note?), Qualifications (education etc), Skills (communication etc), Benefits.
We could separate Requirements as the visa note? Or combine qualifications and requirements? Usually Requirements are things like experience, education etc. Qualifications maybe similar. But we have both sets. We could put education/experience under Requirements, and skills under Skills. However the posting lumps them together under "Qualifications". The list includes degree, experience, therapeutic expertise, language, MS Office, communication, negotiation, team building. Those are qualifications/skills. The visa note is a requirement. So we could have:
- Requirements: visa restriction (maybe also include "Prior experience in Clinical Research..."? but that's also qualification). To avoid duplication, we could treat the bullet list as Qualifications, and the visa note as Requirements.
Thus:
- ... ...
- For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
- College/University degree in Life Sciences or an equivalent combination of education, training & experience is required ... etc (excluding visa note)
About the role
...
Responsibilities
Requirements
Qualifications
Skills
- Communication, presentation and customer-service skills
- Ability to negotiate and build relationships at all levels
- Team building, leadership and organizational skills