Clinical Program Quality Excellence Lead - FSP Team
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate etc. The posting seems to have no boilerplate besides maybe navigation etc not present.
We need to ensure we don't create sections with filler like "commensurate with experience". In EDUCATION section there is "Bachelor’s degree preferred or commensurate with experience". That's a phrase we should keep as is? It's not filler; it's actual content. It's okay.
We must not create Pay/Schedule/Benefits sections unless posting actually states them. We have schedule: "Work Schedule Standard (Mon-Fri) Environmental Conditions Office". That's schedule info. So we can include Schedule section with that line as a
. Benefits and Pay not present, so omit.
Now structure:
About the role
Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle... (the purpose paragraph). We need to include the entire OBJECTIVES/PURPOSE paragraph(s). Let's extract:
"Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle
Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance.
Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation
Champion proactive and continuous prioritization of inspection readiness, focusing on key study operational processes and GCP process excellence, including TMF quality strategies, study-level risk assessments and actioning compliance monitoring signals"
That's multiple sentences; we can combine into a paragraph.
Responsibilities
- Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
- Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
- Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspections
- Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues
- Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
- Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.
- Lead and participate in Strategy Team Meetings and Lead Core Team Meetings for assigned projects
- Ensure effective communication and issue escalation internally and externally with vendors
- Maintain project management documentation such as plans, timelines, and progress reports for ongoing inspection readiness
- Coordinate key activities to enable study team readiness for internal study audits and regulatory inspections, including management of required listings and study team preparedness
- Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses.
- Facilitate and monitor study-specific CAPA related activities in collaboration with GCP Compliance Management and QA
- Identify and implement improvements in inspection readiness and study execution processes.
- Provide regular status updates to stakeholders and leadership.
- Ensure alignment with functional SMEs and cQA in real time throughout study lifecycle and during audits and inspections.
Now Technical/Functional (Line) Expertise, Leadership, Decision-making and Autonomy, Interaction, Innovation, Complexity could be considered Skills or Qualifications. We need to decide sections.
We have "Technical/Functional (Line) Expertise" list: items like Comprehensive understanding..., Effective project management leader..., Advanced expertise in GCP..., Advanced expertise in complex TMF..., Strong ability to learn..., Demonstrated abiltity to monitor... (typo). We'll keep as is.
Leadership list: Demonstrated ability to work across functions..., Excellent communicator..., Proven skills as an effective team player..., Embraces and demonstrates a diversity..., Navigation of changing priorities..., Managing deliverables...
Decision-making and Autonomy list: Accountable for implementing..., Ability to work in fast-paced..., Ability to work with timelines...
Interaction list: Effectively navigates..., Effectively resolve conflict..., Ability to collaborate effectively...
Innovation list: Ability to take risks..., Applies lessons learned...
Complexity list: Ability to work in global ecosystem..., Requires strong attention..., Ability to take ownership...
Education, Behavioural Competencies and Skills: list includes Minimum of 6+ years..., Solid knowledge..., Experience with CROs..., Solid knowledge of drug development..., Experience in clinical trials systems management..., Proven awareness..., Experience in problem solving..., Strong project management..., Must be able to work..., Solid knowledge of regulatory..., Bachelor’s degree preferred..., Must be able to efficiently utilize computer software...
We need to map to sections: Requirements (maybe education/experience), Qualifications (maybe technical expertise), Skills (maybe leadership etc). But we must not create thin sections; prefer few substantive sections.
We could combine all competency lists into a single "Skills and Qualifications" section? But the instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can decide to include Requirements (education/experience), Qualifications (technical/functional expertise), Skills (leadership, decision-making, interaction, innovation, complexity). That seems reasonable.
We must ensure we don't create sections with filler. All have content.
Thus:
Requirements
- Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
- Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
- Solid knowledge of drug development and clinical trial processes, including related standards and documents.
- Experience in clinical trials systems management and oversight (Veeva preferred)
- Proven awareness of sponsor oversight requirements and regulations
- Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required
- Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
- Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
- Solid knowledge of regulatory requirements governing clinical trials and industry best practices
- Bachelor’s degree preferred or commensurate with experience
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Qualifications
- Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, operating models, the prescription drug distribution process, etc)
- Effective project management leader
- Advanced expertise in GCP, ICH and applicable global and local regulatory standards governing clinical research
- Advanced expertise in complex Trial Master File deliverables, TMF structures and electronic document management systems (ie.CTMS, SSU, eTMF), Veeva preferred
- Strong ability to learn new systems and technology quickly and provide training to cross-functional study teams
- Demonstrated abiltity to monitor, interpret and action key performance metrics including study compliance and TMF health data
Skills
- Demonstrated ability to work across functions, regions and cultures
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can influence stakeholders, engender credibility and confidence within the company
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Navigation of changing priorities and communication managment
- Managing deliverables; demonstrating the ability to lead others to drive deliverables forward
- Accountable for implementing resourceful and effective strategies for cross functional team performance; ability to make independent decisions for designated function; escalation of issues as needed.
- Ability to work in a fast-paced environment with demonstrated ability to manage mulitple competing tasks and demands.
- Ability to work with timelines and complete tasks according to deadline.
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Effectively resolve conflict in a constructive manner
- Ability to collaborate effectively with internal and external study team including vendors as needed
- Ability to take risks implementing innovative solutions; comfortable with flexibility to adapt to changing environment.
- Applies lessons learned to continuous improvement of GCP excellence, training and documentation management practices across study teams
- Ability to work in a global ecosystem (internal)
- Requires strong attention to detail in oversight and completion of competing delivarables
- Ability to take ownership and manage tasks, as well as communicate effectively, establishing priorirties, scheduling and monitoring deadlines for multiple complex studies or programs
Now Schedule section:
Schedule
Work Schedule Standard (Mon-Fri) Environmental Conditions Office
We should not include Benefits or Pay.
Now About the role section: we need to include the purpose paragraph. Let's craft a single containing the purpose sentences.
We need to ensure we don't lose any content: The purpose includes four bullet-like sentences but they are separate lines. We'll combine into a paragraph with spaces.
Let's write:
Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle. Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance. Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation. Champion proactive and continuous prioritization of inspection readiness, focusing on key study operational processes and GCP process excellence, including TMF quality strategies, study-level risk assessments and actioning compliance monitoring signals.
Now check for any duplicated lines: none.
Check for boilerplate: none.
Now output only HTML fragment.
Make sure to close
for prose. We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate etc. The posting seems to have no boilerplate besides maybe navigation etc not present. We need to ensure we don't create sections with filler like "commensurate with experience". In EDUCATION section there is "Bachelor’s degree preferred or commensurate with experience". That's a phrase we should keep as is? It's not filler; it's actual content. It's okay. We must not create Pay/Schedule/Benefits sections unless posting actually states them. We have schedule: "Work Schedule Standard (Mon-Fri) Environmental Conditions Office". That's schedule info. So we can include Schedule section with that line as a
. Benefits and Pay not present, so omit. Now structure:
About the role
Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle... (the purpose paragraph). We need to include the entire OBJECTIVES/PURPOSE paragraph(s). Let's extract: "Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance. Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation Champion proactive and continuous prioritization of inspection readiness, focusing on key study operational processes and GCP process excellence, including TMF quality strategies, study-level risk assessments and actioning compliance monitoring signals" That's multiple sentences; we can combine into a paragraph.
Responsibilities
- Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
- Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
- Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspections
- Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues
- Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
- Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.
- Lead and participate in Strategy Team Meetings and Lead Core Team Meetings for assigned projects
- Ensure effective communication and issue escalation internally and externally with vendors
- Maintain project management documentation such as plans, timelines, and progress reports for ongoing inspection readiness
- Coordinate key activities to enable study team readiness for internal study audits and regulatory inspections, including management of required listings and study team preparedness
- Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses.
- Facilitate and monitor study-specific CAPA related activities in collaboration with GCP Compliance Management and QA
- Identify and implement improvements in inspection readiness and study execution processes.
- Provide regular status updates to stakeholders and leadership.
- Ensure alignment with functional SMEs and cQA in real time throughout study lifecycle and during audits and inspections.
Requirements
- Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
- Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
- Solid knowledge of drug development and clinical trial processes, including related standards and documents.
- Experience in clinical trials systems management and oversight (Veeva preferred)
- Proven awareness of sponsor oversight requirements and regulations
- Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required
- Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
- Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
- Solid knowledge of regulatory requirements governing clinical trials and industry best practices
- Bachelor’s degree preferred or commensurate with experience
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Qualifications
- Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, operating models, the prescription drug distribution process, etc)
- Effective project management leader
- Advanced expertise in GCP, ICH and applicable global and local regulatory standards governing clinical research
- Advanced expertise in complex Trial Master File deliverables, TMF structures and electronic document management systems (ie.CTMS, SSU, eTMF), Veeva preferred
- Strong ability to learn new systems and technology quickly and provide training to cross-functional study teams
- Demonstrated abiltity to monitor, interpret and action key performance metrics including study compliance and TMF health data
Skills
- Demonstrated ability to work across functions, regions and cultures
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can influence stakeholders, engender credibility and confidence within the company
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Navigation of changing priorities and communication managment
- Managing deliverables; demonstrating the ability to lead others to drive deliverables forward
- Accountable for implementing resourceful and effective strategies for cross functional team performance; ability to make independent decisions for designated function; escalation of issues as needed.
- Ability to work in a fast-paced environment with demonstrated ability to manage mulitple competing tasks and demands.
- Ability to work with timelines and complete tasks according to deadline.
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Effectively resolve conflict in a constructive manner
- Ability to collaborate effectively with internal and external study team including vendors as needed
- Ability to take risks implementing innovative solutions; comfortable with flexibility to adapt to changing environment.
- Applies lessons learned to continuous improvement of GCP excellence, training and documentation management practices across study teams
- Ability to work in a global ecosystem (internal)
- Requires strong attention to detail in oversight and completion of competing delivarables
- Ability to take ownership and manage tasks, as well as communicate effectively, establishing priorirties, scheduling and monitoring deadlines for multiple complex studies or programs
Schedule
Work Schedule Standard (Mon-Fri) Environmental Conditions Office
We should not include Benefits or Pay. Now About the role section: we need to include the purpose paragraph. Let's craft a singlecontaining the purpose sentences. We need to ensure we don't lose any content: The purpose includes four bullet-like sentences but they are separate lines. We'll combine into a paragraph with spaces. Let's write:
Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle. Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance. Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation. Champion proactive and continuous prioritization of inspection readiness, focusing on key study operational processes and GCP process excellence, including TMF quality strategies, study-level risk assessments and actioning compliance monitoring signals.
Now check for any duplicated lines: none. Check for boilerplate: none. Now output only HTML fragment. Make sure to close