Project Specialist (Sponsor Dedicated/Remote) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. - Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. - Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully apprised of sites and study status. May contact site staff as needed for critical information. - Provide administrative support to Project Leads and functional leads. - Ensure all study documents are archived based on the appropriate guidelines and policy. - Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues. Qualifications - Associate's degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience - Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements. - Strong organizational skills. - Ability to manage time and work independently. - High proficiency with full MS Office Applications. - Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade - Ability to travel if necessary preferred (approximately 5%) - High level of competence in English language Salary - 40,900 - 69,500 Location: - This is a remote/home-based position open to candidates located anywhere within the United States. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Dandy is transforming the massive and antiquated dental industry—an industry worth over $200B. Backed by some of the world’s leading venture capital firms, we’re on an ambitious mission to simplify and modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world-class support to achieve more for their practices, their people, and their patients. Job Description Dandy is hiring a Clinical Support Team Lead (CSL) to join our Customer Experience (CX) Operations team, delivering a best-in-class experience to our dental practice clients. In this role, you will lead a team that handles complex dental inquiries through live chat, phone calls, and other communication channels. You will work alongside a small team of peers to oversee daily operations, ensure high-quality interactions, manage escalations, and improve the efficiency of support processes. You’ll own key performance indicators (KPIs) and collaborate with cross-functional teams to foster continuous education for your team. The ideal candidate is a data-driven leader with a keen eye for operational efficiency, and a solid background in customer service. Shift Time: Mon-Fri, 12pm-9pm ET What You'll Do - Supervise and coach a team of front line associates focused on assisting customers with our dental products, services and tools; guiding best practices to achieve the best outcome for their patients. - Responsible for overall team performance and KPIs: - Manage team of CX reps; coaching and providing customer service guidance - Understand, track and report on KPIs including productivity, accessibility and quality. - Uphold performance standards and deliver feedback in 1:1s - Work with the QA team to audit and deliver actionable agent feedback, identifying gaps in process and building out SOPs to close identified gaps. - Identify operational bottlenecks, propose scalable solutions, and collaborate with cross-functional teams to implement improvements. - Develop, maintain, and optimize Standard Operating Procedures (SOPs) to ensure consistency, efficiency, and scalability. - When faced with problems, you use non-standard approaches and root cause analysis to independently resolve issues. - Demonstrates an understanding of data and uses analysis to positively impact your area of ownership. - Foster a positive, collaborative team environment that prioritizes customer experiences and operational excellence. What We're Looking For - 2+ years of frontline leadership experience in customer service, ideally in a startup or tech company. - 1+ years of direct people management or supervisory experience as a title manager is required. - Proven ability to manage and develop a team, driving measurable performance improvements. - Customer service experience required, with proven ability to adapt and empathize with customers to de-escalate situations and offer solutions. - Basic understanding of tech platforms and the ability to learn new platforms quickly. Prior experience with Zendesk is preferred. - Comfort operating in ambiguous, high-velocity environments with a proactive and resourceful approach. - Willingness to roll up your sleeves and fix problems in a hands-on manner. - Intellectual curiosity and a data-driven mindset, with the ability to analyze performance metrics and implement improvements. Additional Considerations - Previous experience in a healthcare or clinical setting. - Familiarity with the dental industry or prior experience in dentistry. - A positive attitude, sense of humor, and ability to foster a fun and engaging team culture. Req ID: J-21 For full-time positions, Dandy offers a wide range of best-in-class, comprehensive, and inclusive benefits tailored to each country where we operate. Our local benefits packages typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off—ensuring our team members are supported no matter where they live and work. Dandy is proud to be an equal-opportunity employer. We are committed to building a diverse and inclusive culture that celebrates authenticity to win as one. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, citizenship or immigration status, or any other legally protected characteristics. Dandy also fully complies with the Americans with Disabilities Act (ADA). We are dedicated to embracing challenges and creating an accessible, inclusive workplace for all individuals. If you require any accommodations for your interview or have any questions beforehand, rest assured that we will do everything we can to meet your needs. Visit Dandy Careers for more! Data Privacy Notice: By submitting your application, you consent to Dandy collecting, storing, and processing your personal information for recruitment purposes in accordance with our Privacy Policy and GDPR regulations. You have the right to access, rectify, or request the deletion of your data at any time by contacting Privacy Requests.

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.