Senior Clinical Lead
ProPharma · Raleigh, NC · 1 mo ago
RemoteRemoteHealthcareFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where there is real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate like EEO, scam warning, etc. Must preserve all substantive info.
Let's parse the posting.
First paragraph: "For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs."
That's about the company, could be "About the role"? Actually it's about the company. Could be placed under "About the role" maybe. The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have About the role section containing that description.
Next: "Essential Functions" then a long list of duties. That's responsibilities. So we need a Responsibilities section with
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have About the role section containing that description.
Next: "Essential Functions" then a long list of duties. That's responsibilities. So we need a Responsibilities section with - for each duty.
Then "Necessary Skills And Abilities" then bullet-like sentences. That's Skills.
Then "Educational Requirements" then "Experience Requirements". Those could go under Requirements or Qualifications. The instruction: Use sections Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide where to put education and experience. Likely under Requirements (or Qualifications). The distinction: Requirements could be education/experience; Qualifications could be skills? But we already have Skills section. So we can put education and experience under Requirements. Or we could have both Requirements and Qualifications sections: Requirements for education/experience, Qualifications for maybe other qualifications? But we have Skills separate. Let's follow typical: Requirements = education + experience; Qualifications = maybe certifications? Not present. So we can have Requirements section containing education and experience. Skills section containing necessary skills and abilities.
Benefits, Pay, Schedule: The posting mentions remote work, hybrid basis encouragement, but no explicit benefits, pay, schedule. It says: "Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager." That's about schedule/location. Could be considered Schedule? It's not explicit schedule like full-time/part-time, but it's about work arrangement. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does mention remote/hybrid work, which is about schedule/location. So we could include a Schedule section with that info. Benefits: not mentioned. Pay: not mentioned. So we omit Benefits and Pay.
We also need to remove boilerplate: EEO, diversity statement, equal opportunity, scam warning, etc. Also remove lines like "We celebrate our differences..." etc. Also remove "All applications to roles at ProPharma are personally reviewed..." etc. Also remove "***ProPharma Group does not accept unsolicited resumes..." etc.
We must preserve all substantive information. So we keep the company description, essential functions, necessary skills and abilities, educational requirements, experience requirements, and the hybrid work statement.
We need to format as HTML fragment: use
for each section heading, then content:
for prose,
- for lists.
We need to ensure we don't repeat job title as heading. No job title given.
Let's extract responsibilities list from "Essential Functions" paragraph. It's a long sentence with many duties separated by periods. We need to break into list items. We'll parse each duty.
Essential Functions text:
"Oversight and management of the investigator site management and monitoring activities and the clinical monitoring teams for the assigned studies during the startup, execution, and close out phase of the study.
Functions as the lead site management resource for the client, investigational site, and the internal study team.
Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, and standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations.
Provides input and supports development of study specific training material, and as appropriate provides study-specific training for the assigned clinical monitoring teams.
Oversees quality of clinical monitoring deliverables to clients and may conduct Quality Co-monitoring visits to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance.
Responsible for the review and approval of study monitors’ site visit reports for the investigational sites on assigned studies within appropriate process requirements.
Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is not limited to clinical monitoring plan.
Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring.
Assures compliance with study monitoring plan and collaborates with cross functional teams to ensure timely site initiate process.
Leads and supports any study specific requirements related to site performance, including but not limited to patient recruitment, site payments, study material needs, etc.
Works closely with clinical project management team and provides status report for onsite initiations, enrollment, visit schedules, trip report completion and any other status report as per the company and/or project specific requirements.
Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any issues and seeking guidance as needed.
Maintains timely and effective communication among team members and site personnel as assigned.
May be responsible for the supervision and administrative oversight of the direct reports within the company expected framework.
The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemed appropriate.
Other duties as assigned."
We'll turn each line into
- .
Now Necessary Skills And Abilities:
"Demonstrated ability to perform CRA activities at an advanced level.
Demonstrated ability to lead a team of Clinical Operations. professionals in the successful execution of clinical trials.
Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals.
Experience managing/mentoring and developing junior staff."
We'll make list.
Educational Requirements: "Bachelor’s degree preferred. Candidates with equivalent combination of education, training, and experience will be considered."
Experience Requirements: "5 + years of experience working in clinical research is preferred, including clinical research associate experience. Prior LCRA and/or Clinical Lead experience is preferred. Excellent verbal and written communication skills; interpersonal and presentation skills are required. Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials. Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials."
Note that some of these are skills; but they are under Experience Requirements. We could keep them there. However we also have Skills section for Necessary Skills And Abilities. There's overlap: communication skills, Microsoft Office, eTMF etc. Might be duplicated. But we must preserve all substantive information; we can keep them in Requirements section (education+experience) and also maybe in Skills? But to avoid duplication, we could put all experience-related items under Requirements, and the Necessary Skills And Abilities under Skills. However the Experience Requirements includes communication skills etc., which are also skills. It's okay to have them in Requirements.
We'll create Requirements section with two subparts: Education and Experience. Could be separate paragraphs.
Now Schedule: The hybrid work statement: "Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office."
We'll put that in Schedule section as prose.
Now we need to remove boilerplate: The diversity statement, EEO, scam warning, etc. Also remove the line about "We celebrate our differences..." etc. Also remove "All applications to roles at ProPharma are personally reviewed..." etc. Also remove "***ProPharma Group does not accept unsolicited resumes..." etc.
Now produce HTML.
Structure:
About the role
... company description ...
Responsibilities
- ...
...
Requirements
Education: Bachelor’s degree preferred. Candidates with equivalent combination of education, training, and experience will be considered.
Experience: 5+ years of experience working in clinical research is preferred, including clinical research associate experience. Prior LCRA and/or Clinical Lead experience is preferred. Excellent verbal and written communication skills; interpersonal and presentation skills are required. Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials. Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
Skills
- Demonstrated ability to perform CRA activities at an advanced level.
- Demonstrated ability to lead a team of Clinical Operations professionals in the successful execution of clinical trials.
- Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals.
- Experience managing/mentoring and developing junior staff.
Schedule
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
We should not include Benefits or Pay sections.
Check that we preserved all substantive info: company description, responsibilities list, necessary skills, education, experience, hybrid work statement. Did we miss any? The original also had "Essential Functions Oversight and management..." we captured. Also "Other duties as assigned." included.
We removed the line "We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed." That's boilerplate EEO, removed.
We removed "All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not." That's application instructions/boilerplate, removed.
We removed "Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices
for each section heading, then content:
for prose,
- for lists. We need to ensure we don't repeat job title as heading. No job title given. Let's extract responsibilities list from "Essential Functions" paragraph. It's a long sentence with many duties separated by periods. We need to break into list items. We'll parse each duty. Essential Functions text: "Oversight and management of the investigator site management and monitoring activities and the clinical monitoring teams for the assigned studies during the startup, execution, and close out phase of the study. Functions as the lead site management resource for the client, investigational site, and the internal study team. Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, and standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations. Provides input and supports development of study specific training material, and as appropriate provides study-specific training for the assigned clinical monitoring teams. Oversees quality of clinical monitoring deliverables to clients and may conduct Quality Co-monitoring visits to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance. Responsible for the review and approval of study monitors’ site visit reports for the investigational sites on assigned studies within appropriate process requirements. Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is not limited to clinical monitoring plan. Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring. Assures compliance with study monitoring plan and collaborates with cross functional teams to ensure timely site initiate process. Leads and supports any study specific requirements related to site performance, including but not limited to patient recruitment, site payments, study material needs, etc. Works closely with clinical project management team and provides status report for onsite initiations, enrollment, visit schedules, trip report completion and any other status report as per the company and/or project specific requirements. Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any issues and seeking guidance as needed. Maintains timely and effective communication among team members and site personnel as assigned. May be responsible for the supervision and administrative oversight of the direct reports within the company expected framework. The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemed appropriate. Other duties as assigned." We'll turn each line into
- .
Now Necessary Skills And Abilities:
"Demonstrated ability to perform CRA activities at an advanced level.
Demonstrated ability to lead a team of Clinical Operations. professionals in the successful execution of clinical trials.
Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals.
Experience managing/mentoring and developing junior staff."
We'll make list.
Educational Requirements: "Bachelor’s degree preferred. Candidates with equivalent combination of education, training, and experience will be considered."
Experience Requirements: "5 + years of experience working in clinical research is preferred, including clinical research associate experience. Prior LCRA and/or Clinical Lead experience is preferred. Excellent verbal and written communication skills; interpersonal and presentation skills are required. Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials. Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials."
Note that some of these are skills; but they are under Experience Requirements. We could keep them there. However we also have Skills section for Necessary Skills And Abilities. There's overlap: communication skills, Microsoft Office, eTMF etc. Might be duplicated. But we must preserve all substantive information; we can keep them in Requirements section (education+experience) and also maybe in Skills? But to avoid duplication, we could put all experience-related items under Requirements, and the Necessary Skills And Abilities under Skills. However the Experience Requirements includes communication skills etc., which are also skills. It's okay to have them in Requirements.
We'll create Requirements section with two subparts: Education and Experience. Could be separate paragraphs.
Now Schedule: The hybrid work statement: "Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office."
We'll put that in Schedule section as prose.
Now we need to remove boilerplate: The diversity statement, EEO, scam warning, etc. Also remove the line about "We celebrate our differences..." etc. Also remove "All applications to roles at ProPharma are personally reviewed..." etc. Also remove "***ProPharma Group does not accept unsolicited resumes..." etc.
Now produce HTML.
Structure:
About the role
... company description ...
Responsibilities
- ... ...
Requirements
Education: Bachelor’s degree preferred. Candidates with equivalent combination of education, training, and experience will be considered.
Experience: 5+ years of experience working in clinical research is preferred, including clinical research associate experience. Prior LCRA and/or Clinical Lead experience is preferred. Excellent verbal and written communication skills; interpersonal and presentation skills are required. Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials. Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
Skills
- Demonstrated ability to perform CRA activities at an advanced level.
- Demonstrated ability to lead a team of Clinical Operations professionals in the successful execution of clinical trials.
- Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals.
- Experience managing/mentoring and developing junior staff.
Schedule
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
We should not include Benefits or Pay sections. Check that we preserved all substantive info: company description, responsibilities list, necessary skills, education, experience, hybrid work statement. Did we miss any? The original also had "Essential Functions Oversight and management..." we captured. Also "Other duties as assigned." included. We removed the line "We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed." That's boilerplate EEO, removed. We removed "All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not." That's application instructions/boilerplate, removed. We removed "Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices