Senior Start-up Specialist
hace 2 días
Job Summary:
The jobholder, an SME for local/regional regulations, works with multiple vendors, drives and coordinates activities across a range of stakeholders in support of site start up delivery.
This role liaises with Covance Regulatory to ensure compliance, coordinates best practice solutions within region and coaches others in the more complex areas of SU. The Senior SU Specialist proactively anticipates and mitigates issues that could delay start up across a range of sites. Is the escalation point for negotiations with SUPM/SUCM’s on behalf of less senior colleagues.
Essential Job Duties: These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties
These are the specific areas of accountability requiring decisions or delivery of results. Most positions have between six to ten key job duties. In this section, list and describe the position’s principal responsibilities in concise, but comprehensive statements. Include those accountabilities that are critical to the successful performance of the job. Indicate % of time in a single work week spent on top 5-10 duties (no less than 5% increments).
Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.
When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness.
Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
Ensure efficient in country execution and local improvements aligned with global requirements.
Review and approve projections and timelines to study teams, ensuring that they accurately represent the country’s performance and suggests mitigation actions in agreement with SUCM.
Develop project specific plans for the Site Activation component of assigned studies
When appropriate, take a lead in team meetings to resolve issues and progress the trial
Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM.
Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
Liaise with Covance regulatory regarding document submission requirements Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes
Coach other start-up team members
May take country start up lead role for larger/more complex projects
May have line management responsibilities for a small number of staff, including performance management, career development, regular one to one’s salary and promo recommendations
Perform other duties as assigned by management
Experience: Minimum Required:
In depth experience of issue escalation and resolution.
Credible role model in effective communication and problem solving.
Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.
Education/Qualifications/Certifications and Licenses Recommended:
Level of education preferred (if required or experience level which may be substituted for level of education). Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our Privacy Statement.
-
Start-up Specialist
hace 4 semanas
Colonia Lomas de Chapultepec, México Labcorp A tiempo completoSupport the negotiation of site contracts and budgets with sites, and track progress of contract and budget milestones/developments, intervening and escating as appropriate. - Maintain awareness of legislation, guidance and practice in the assigned countries. - Coordinate, Collect and organize data and information required by EC/IRB/Third body/Regulatory...
-
Start-up Specialist
hace 3 semanas
Colonia Lomas de Chapultepec, México Labcorp A tiempo completo**Labcorp is proud to be an Equal Opportunity Employer**: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race,...
-
Start-up Specialist
hace 4 días
Colonia Lomas de Chapultepec, México Labcorp A tiempo completoCompleted job training (office management, administration, finance, health care preferred) or Bachelor’s Degree. Ideally an accountant by profession or with extensive experience in payments and financial processes. - Minimum 1-2Y in Clinical Research or relevant healthcare experience **Labcorp is proud to be an Equal Opportunity Employer**: As an EOE/AA...
-
Start-up Specialist
hace 1 semana
Colonia Lomas de Chapultepec, México Labcorp A tiempo completoCollect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance - Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner. - Proactively manage sites to ensure timely site activation and escalate study...
-
Study Start Up Associate I
hace 6 días
Ciudad de México, CDMX ICON Plc A tiempo completoStudy Start Up Associate I - Contracts & budgets - Mexico - Homebased 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 We are currently seeking a...
-
Study Start Up Associate
hace 1 día
Ciudad de México, CDMX Icon plc A tiempo completoStudy Start Up Associate (All levels: I, II and Sr) - Remote - Mexico 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 We are currently seeking a...
-
Start Up Specialist
hace 1 semana
Ecatepec de Morelos, México Icon A tiempo completoICON 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 role holder will contribute to best practices guidance or operational excellence activities to...
-
Regulatory And Start Up Specialist 2
hace 4 horas
Ecatepec de Morelos, México Tn Spain A tiempo completoSocial network you want to login/join with: Regulatory and Start Up Specialist 2 (FSP) (ICF Specialist), Madrid Client: IQVIA Location: Madrid, Spain Job Category: Other EU work permit required: Yes Job Views: 4 Posted: 06.03.2025 Expiry Date: 20.04.2025 Job Description: Job Overview Perform tasks at a country level associated with Site Activation (SA)...
-
Senior Centralized Study Associate
hace 5 días
Colonia Lomas de Chapultepec, México Labcorp A tiempo completoYou will join an international team dedicated to support all types of clinical trials at the start up as during the course of the study. Main tasks consist of document review: - Review Initial Greenlight Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical...
-
Study Start Up Associate Ii
hace 5 días
Ciudad de México ICON A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
-
Site Start-Up Manager
hace 5 días
Pachuca de Soto, Hidalgo, México Syneos Health, Inc. A tiempo completoRole DescriptionThe Senior Clinical Contract Specialist will lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents. The specialist will also work closely with internal and external teams to ensure smooth execution of projects.About the ProjectsWe are working on various projects related to clinical trials....
-
Study Start Up Coordinator
hace 3 días
Ciudad de México, Ciudad de México CTI Clinical Trial and Consulting Services A tiempo completoRegulatory Affairs, Study Start Up Specialist IICompany Overview:CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.Job Description:This role involves assisting project teams with...
-
Sales Specialist
hace 4 semanas
Colonia Lomas de Chapultepec, México Landing A tiempo completo**About Landing**: Since 2019, Landing has redefined apartment renting with the industry’s first flexible living model. Our membership program provides consumers with access to a network of apartments in 50+ markets with no deposits, hassles, or stress. With fully furnished, flexible-lease apartments across 375+ cities, Landing has transformed the rental...
-
Senior Technical Account Specialist
hace 5 días
Ciudad de México, Ciudad de México Information Technology Senior Management Forum A tiempo completoAbout UsAt Information Technology Senior Management Forum, we strive to provide open and transparent markets that empower everyone to access opportunities. By centralizing data, analytics, and market intelligence, we aim to break down barriers to inclusive prosperity.We are currently seeking a Senior Technical Account Specialist to join our team in Vilnius....
-
Site Start-Up Specialist
hace 21 horas
Ciudad de México, Ciudad de México ICON plc A tiempo completoRole Overview:In this role, you will have the opportunity to work with a dynamic team, contributing to the success of our clients through expert site activation services. As a Senior Site Activation Lead, your primary responsibility will be to oversee the activation of investigative sites, ensuring timely and high-quality delivery of key milestones. You will...
-
Sales Market Merchandising Specialist
hace 2 semanas
Colonia Lomas de Chapultepec, México H&M A tiempo completoCompany Description As one of the world’s largest fashion companies with more than 120,000 employees worldwide, H&M is an exciting and dynamic place to pursue a career within the fashion industry. Our business concept is to offer fashion and quality at the best price in a sustainable way and with our fast expansion we are always looking for new talents....
-
Senior Information Security Specialist
hace 2 días
Ciudad de México, Ciudad de México Citigroup Inc. A tiempo completoSenior Information Security Specialist Job SummaryWe are seeking an experienced Senior Information Security Specialist to join our Information Security team. As a Senior Information Security Specialist, you will be responsible for leading the development and implementation of information security policies and procedures. You will also be responsible for...
-
Membership Sales Specialist
hace 4 semanas
Colonia Lomas de Chapultepec, México Landing A tiempo completo**_Important note: This position is in office not remote. In order to be considered for the position, submitted resume must be in English._** We are looking for our next **Membership Sales Specialist **to join us at Landing! In this role, you’ll work on our New Member Team to follow up with new leads, generate revenue by closing new memberships and...
-
Study Start Up Associate I
hace 6 días
Ciudad de México, CDMX ICON Plc A tiempo completoStudy Start Up Associate I - Site Activation Associate I - Mexico - Remote 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 At ICON, it’s our...
-
Senior Database Specialist
hace 3 días
Santiago de Querétaro, Querétaro de Arteaga, México Scale Up Recruiting Partners A tiempo completoWe are seeking an experienced Sr DBA to join our team at Scale Up Recruiting Partners as a part-time Senior Database Administrator for a 3-week project.About the Project:This is a part-time role, requiring 10-20 hours of work per week.The project duration is 3 weeks.The successful candidate will be responsible for designing, installing, configuring, and...