Global Study Associate Director
ICON Strategic Solutions · United States · 3 wk ago
RemoteRemoteAnalystFull-time
We need to output HTML fragment with sections: About the role? The posting includes description after "Global Study Associate Director (oncology) At ICON Strategic Solutions, you will work..." That's like about the role. Then "What You Will Do" is responsibilities. Then "Your Profile" is qualifications/requirements. Then "What ICON Can Offer You" includes benefits. No explicit Pay or Schedule. So we should include sections: About the role (maybe not required but we can include as heading). The instruction: use inside
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use those headings if content exists. We need to preserve all substantive information, remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes EEO statement and accommodation request, also "Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless..." and "Are you a current ICON Employee? Please click here to apply". Those are application instructions / EEO boilerplate, should be removed. Also remove "Visit our careers site to read more about the benefits ICON offers." maybe part of benefits but it's a link instruction; could be considered boilerplate. We'll keep benefits description but remove that sentence. We need to not repeat job title as heading. So no heading for the title. We need to output only HTML fragment. Let's extract content: About the role: first paragraph: "Global Study Associate Director (oncology) At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide." We can put that in
under
About the role
. Responsibilities: "What You Will Do" bullet list (actually sentences). We'll convert each sentence to- . Need to preserve all details.
List items:
- Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
- Lead and facilitate communication across all functions, including external partners and service providers.
- Lead and conduct investigator meetings and other study related meetings.
- Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
- Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
- Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
- Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
- Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
- Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
- The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
- Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
We need to ensure no duplication. Looks fine.
Your Profile: "University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research5 + years of relevant clinical experience in the pharmaceutical industry focused in Clinical Project/Trial ManagementExperience overseeing large global clinical trial projects Experience overseeing Oncology studies/projects is required"
There's a missing space after "research5". We'll keep as is but maybe fix spacing? We must preserve ALL substantive information; we should not invent or summarize away detail, but we can correct obvious typo? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. Changing "research5" to "research. 5" might be considered inventing? It's a typo; but we could keep as is. Probably better to keep exactly as given: "research5 + years". We'll keep.
We'll split into list items:
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research5 + years of relevant clinical experience in the pharmaceutical industry focused in Clinical Project/Trial Management
- Experience overseeing large global clinical trial projects
- Experience overseeing Oncology studies/projects is required
But the first bullet is long; maybe better to keep as a paragraph? The instruction: Use
- for any list of duties/requirements/benefits, and
for prose. So if it's a list, we should use list. The "Your Profile" seems like a list of requirements. We'll make list. Benefits: "What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers." We need to remove the sentence "Visit our careers site to read more about the benefits ICON offers." as it's application instruction/link. Also maybe remove "Our Benefits Examples Include" as heading? We'll keep as prose. We'll make a
- for each benefit item? The benefits are listed as sentences: "Various annual leave entitlements", "A range of health insurance offerings to suit you and your family’s needs.", "Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.", "Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.", "Life assurance", "Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others." We'll put each as
- . Also we have introductory prose before list: "Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family." That can be a
before the list. We must not include Pay or Schedule sections as not present. Now construct HTML:
About the role
Global Study Associate Director (oncology) At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Responsibilities
- Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget and quality standards. May hold accountability and/or oversight of several studies.
- Lead and facilitate communication across all functions, including external partners and service providers.
- Lead and conduct investigator meetings and other study related meetings.
- Provide input into and hold accountability for the development of essential study level documents (i.e., Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs.
- Develop and maintain relevant study plans including required input into study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
- Ensure all external service providers (i.e., Contract Research Organizations (CROs), central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented and any issues are escalated appropriately. May participate in vendor selection activities.
- Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.)
- Oversee Trial Master File (TMF) completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times
- Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, financial system attestations, Clinical Trial Transparency)
- The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process)
- Ensure studies are inspection-ready at all times, according to ICH-GCP and SOP and relevant policies/guidelines; GSAD is the primary Study Management point-of-contact in the event of an audit or inspection
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
Requirements
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research5 + years of relevant clinical experience in the pharmaceutical industry focused in Clinical Project/Trial Management
- Experience overseeing large global clinical trial projects
- Experience overseeing Oncology