Principal Clinical Data Scientist Lead (COA Lead) - Spain/Poland/Ireland/UK/US - Home or office based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in role and demonstrates ability to take more in quantity (TA portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications). Responsibilities - Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging - Contribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sponsor’s Best In Class / First In Class approach - Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research - Advise on the use and/or development of Fit-for-Purpose COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination - Ensure proper input into medical evidence generation plans, and effective implementation related to COAs throughout execution - Manage the qualitative and quantitative research projects to close the validation gap(s) on the selected COA instruments (including vendor management) - Prepare the scientific documents (reports, regulatory documents, publications,...) for internal and external communication - Manage vendors as needed (from Request For Proposal to reception of deliverables, including project management and budget control). Specific role activities for a COA Lead also include advanced activities: - Leads specific internal organizational initiatives, within COA and PID-HVT (eg. RACI, templates, guidance) - Advocate for the role of quantitative and qualitative COA across Sponsor, participate in creating and delivering education on COAs for internal business partners - Identify, track and participate in global external collaborations regarding policy, standards and use of COAs e.g. Critical Path PRO Consortium, ISPOR and DIA Working Groups, IMI… - Mentor more junior COA scientists, share specific knowledge and expertise with the COA team. - Provide direction and delegate specific tasks to associate COA scientist - Implement new methodologies and promote innovative approaches. - Define or update overarching approach and framework to COA endpoints strategies in strategic area (eg Oncology, I&I, rare diseases) - - Experience needed - Relevant experience in COA in Pharma/CRO/Consultancy : ideally proven track record from scientific publications in core COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation - Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment - Qualification - Relevant advanced academic degree (e.g. doctorate or masters in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics…) - Training in COA methods - Soft and technical skills : - Strong analytical and synthesis skills of qualitative and quantitative data - Accountability and hands-on mindset, autonomy and sense of initiative - Scientific rigor, Attention to detail, Analytical Thinking - Good interpersonal and communication skills, both written and oral - Ability to manage multiple priorities and projects, and balance workload and timelines - Appetite for innovation and change management - Ability to interact and manage external and internal networks 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Fortrea's FSP Team is hiring a TMF Lead II! Remote US. Seeking strong experience in heavy metrics reporting and KPI development. The TMF Management team is responsible for the completeness and accuracy of the Trial Master File (TMF) for all sponsored studies. The TMF Lead II is the Subject Matter Expert for TMF across all research phases and collaborates cross-functionally with members of the study teams. The TMF Lead II will provide project management principles for all sponsored clinical trials throughout the lifecycle of the trial. TMF Lead II will drive INSPECTION READINESS efforts for the team. Key deliverables include providing TMF expertise, monitoring and assessing the overall TMF Health (quality, completeness, and timeliness), delivering technical expertise on the electronic TMF (eTMF) and supporting Inspection Readiness goals in compliance with ICH/GCP guidelines. Job Overview: Manages and supports the study TMF right from the study set up to the closeout, including the transfer of the TMF. Managing study TMF health and completeness. Responsible for initiating the Review workflow. Summary of Responsibilities: · The position provides process, control, coordination, and approval of clinical trial documents. · The position is responsible for ECD, Phase I-IV electronic trial master file (eTMF). · Is the primary TMF Delivery Center point person for assigned studies. · Conduct TMF-specific Kick-off Meeting with Sponsor and Fortrea project team to establish expectations, requirements and deliverables in line with ICH and to support scope build. · Oversees the planning, set-up, maintenance, QC, and closure of the study TMF for clinical studies, in accordance with agreed TMF processes (Fortrea or sponsor SOPs) working with key study personnel as identified. · Confirms internal and external system access needs. · Assist with generating various reports, metrics and analyzing trends across studies, countries and sites. · Accountable for the creation and maintenance of the TMF Plan and TMF Index in collaboration with the Project Manager/Project Lead and Sponsor. · Maintenance of access within the TMF system in collaboration with the TMF access management team. · Complete required eTMF system training for sponsor systems. · Provide project team training on study specific TMF plan and Index or other Trainings, as required. · Document and escalate all identified compliance issues. Follow-up findings until resolution/CAPA implementation. · Monitor project scope and communicate any identified out-of-scope activity or requests to the Project Lead. · Receive sponsor-specific report requests (confirm required, within scope). Work with appropriate TMF operational services and TMF system experts to evaluate the feasibility of sponsor-specific report requests and ensure development and delivery as appropriate. · Oversees the preparation of the TMF for QA or Sponsor Audits and Inspections and participates in Audit and Inspections as required. Responds to any CAPAs issued on guidance with the Management Team. · Maintains the TMF in a state of audit/inspection readiness by: · Completing the Initial matching of Index with Expected Document List (EDL) update for required documents and count, in collaboration with leads from each functional group within the study. · Ensure ongoing "real-time" EDL maintenance updates are maintained by each functional group per assigned study. · Oversee timely kick-off of TMF Review Workflows on or before 25th Day of the Milestone Release. · Responsible for monitoring completeness of the study TMF at each Milestone Review. · Escalates missing, incomplete, incorrect, inaccurate artifacts to the appropriate study team members. Setting up a monthly meeting with the Study Team. · Oversee the processing of essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs (as applicable), GCP, and ICH guidelines. · Leads Project Review/Governance debrief and set up meetings on the same. · Reports on Portfolio and Study Level Key Performance Indicators (KPIs) as applicable, monitors study metric compliance, and provides remediation guidance as required. · Identifies trends per study and across programs; alerts management of trends as applicable. · Review and respond to TMF content quality issues. · Assists the TMF Remediation team as and when required for assigned studies. · Attend and/or present at internal or external study team meetings as required. · Maintain awareness of study events and the associated documentation requirements. · Maintains effective internal and external communication. · Collaborates with all members of TMF Operational Services. · Contributes overall client satisfaction. · Maintains an understanding of applicable regulatory requirements. · Contributes to business development opportunities. · Act as the Point of Contact for Technical Issues faced by other TMF DC roles (e.g.: Classifiers, Reviewers) during maintenance of the TMF in the UCV system. · Manage complex and large studies. · Helps in drafting the job aids and WI if any. · Helps in Migration if any. · Performs training and mentoring as required. · All other duties as needed or assigned. Qualifications (Minimum Required): - BS/BA degree in related discipline and a minimum of six-seven years of related experience; or, - MS/MA degree in related discipline and a minimum of three years of related experience; or, - Equivalent combination of education and experience. Experience (Minimum Required): - Minimum 7 years’ experience working in a clinical research environment. - 5+ years experience in TMF - Clear understanding of GCP and ICH guidelines. - Knowledge of Regulatory/Clinical document requirements. - Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs. Preferred Qualifications Include: - Masters’s Degree with a Life Sciences/Business focus. - Equivalent experience within clinical research environment of a minimum of 11-13 years, may be substituted for education requirements. - Experience working in clinical electronic systems preferred. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: - Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) - 401(K) - Paid time off (PTO) – Flex Plan - Employee recognition awards - Multiple ERG’s (employee resource groups) - Target Pay Range (based on title): $100-118K #LI - Remote Applications will be accepted on an ongoing basis. Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. Learn more about our EEO & Accommodations request here.

• The Senior Clinical Trial Manager (Sr. CTM) serves as the clinical functional lead, accountable for the delivery of site management, clinical monitoring and central monitoring of assigned study(ies). • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • This may include accompanying CRA team members to sites for observation or conflict resolution. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Reviews and provides feedback on other functional plans (eg. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and/or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. • Document requested revisions and approvals in CTMS. • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. • Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). • Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. • Develop and support execution of corrective action plans at site and study level. • Supports and completes activities to achieve data cut and lock deadlines. • Provides feedback to line managers on staff performance including strengths as well as areas for development.