Specialist, Country Study Start Up

hace 3 semanas


Ciudad de México ABBVIE A tiempo completo

**Purpose**:The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.
- Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads_

**Primary responsibilities**:

- Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites
- Establish the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs
- Proactively identify and communicate issues impacting delivery and providing proposed solutions.
- Attend regional/area start up calls and providing input for assigned sites/studies
- Collection of essential documents from sites and completing quality check (ALCOA)
- Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting
- Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements
- Collaborate with contract manager, CRA, Area CSM Lead as required to assure timely site activation
- Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas
- Trigger clinical supply shipments
- Complete IP release activities and triggering IP shipment
- Issue site green light letter and activating sites in IXRS
- Track all start up and maintenance related activities in Vault SSU as appropriate
- Maintain local country and site intelligence database and EDLs in Vault.
- Maintain SSU performance metrics and KPIs for assigned sites/studies.
- Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
- Ensure audit/inspection readiness
- Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
- Participate in process improvement initiatives as required

**Qualifications**:

- Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
- A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
- Experience working with remote/virtual teams
- Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
- Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
- Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment
- Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment



  • Ciudad de México Novasyte A tiempo completo

    Unleash Your Potential It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see where...


  • México Thermo Fisher Scientific A tiempo completo

    Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy. -...


  • Ciudad de México Medpace, Inc. A tiempo completo

    Job Summary: Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Study Start-Up Manager (Regulatory Submissions Manager) to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position plays a key role in the clinical trial management process at Medpace. If you want an...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...


  • Ciudad de México Novartis Argentina A tiempo completo

    Job ID- 363000BR- Mar 06, 2023- Mexico**Job Description**: - +3000 People in the Novartis CONEXTS team, a global network of internal specialists providing high quality commercial, scientific, legal, digital and consulting services and solutions across the entire Novartis organization, with a focus on key markets, product launches and strategic initiatives....


  • Ciudad de México Pfizer A tiempo completo

    JOB SUMMARY The Site Relationship Partner is the main Pfizer point of contact for investigative sites; accountable for site start-up activities through site activation; accountable for building and retaining investigator site relationships and providing support from site recommendation through the lifecycle of studies. The Site Relationship Partner is the...


  • Ciudad de México Novartis A tiempo completo

    The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements. The CPM is the single point of contact and study team lead,...


  • Ciudad de México Novartis A tiempo completo

    The SSO Site Partnership Manager optimizes the cooperation with selected trial sites, considered key accounts for Novartis with huge potential to significantly contribute to the portfolio execution, aiming to improve performance in clinical studies regarding patient numbers, timelines, data flow and quality and thus establishes Novartis as partner of choice...

  • Ctry Approval Assoc

    hace 3 semanas


    Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionEssential Functions and Other Job Information: Essential FunctionsPrepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.Coordinates, under guidance, with...


  • Ciudad de México ICON A tiempo completo

    **Specialist, Patient Recruitment - Mexico City** **The Patient Recruitment Specialist **will support the assigned Sr. Specialist/Manager/Sr. Manager with the development and execution of Patient Recruitment and Retention strategies and tactics appropriate to the awarded study needs and in alignment with the Sponsor requirements. **The Role** - Support...


  • Ciudad de México Stellantis A tiempo completo

    **Job ID**: 2002106 **Career Area**: Manufacturing **Job Category**: **Location**: FCA Mexico - Santa Fe Corporate Services 1210, MX **Date Posted**: May 9, 2023 **Brand**: FCA Group Job Overview **Qualifications**: The Pre-Study logistics process specialist will be responsible for all manufacturing roll-ups of future North America programs including...


  • Ciudad de México Fortrea A tiempo completo

    Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea 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, religion,...

  • Cx / UX Specialist

    hace 1 mes


    Ciudad de México Santander A tiempo completo

    CX / UX Specialist Country: Mexico **WHAT YOU WILL BE DOING** Diseñar User flows de las funcionalidades - Diseñar el UI del producto digital - Diseñar microinteracciones y soluciones usables - Diseñar los sitemaps - Enrtregar los assests al UX developer y Frontend para consruir los productos - Apoyar al PO a materializar las solcuciones del producto -...


  • Ciudad de México Stellantis A tiempo completo

    **Job ID**: 2002105 **Career Area**: Manufacturing **Job Category**: **Location**: FCA Mexico - Santa Fe Corporate Services 1210, MX **Date Posted**: May 9, 2023 **Brand**: FCA Group Job Overview **Qualifications**: The WTB (Want to Be) specialist within the PreStudy Team (PST) is responsible for coordination of all assembly plant WTB activities that...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThis position plays a key role in overseeing trial and site administration. Working closely with senior management, the individual is responsible for preparing, organizing, distributing, and archiving clinical documents. In addition, they provide vital support for clinical and non-clinical supply management, ensuring accurate tracking and...

  • Study Startup Lead

    hace 5 días


    México PSI CRO A tiempo completo

    **Company Description** We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to...


  • Ciudad de México IKEA A tiempo completo

    **Company description** The IKEA vision is to create a better everyday life for the many people. We do this by offering a wide range of well-designed, functional home furnishing products at prices so low that as many people as possible can afford them. We operate in Singapore, Malaysia and Thailand - and have an ambitious expansion plan to bring a little bit...

  • Tax Specialist

    hace 2 días


    Ciudad de México, Ciudad de México Alcon A tiempo completo

    The main responsibilities include:• The Tax & Statutory accounting Specialist is responsible for supervise and drive all operational tax with the Tax advisor in Country.This role will ensure tax activities are aligned to Alcon global tax strategy and follows local laws as well as international standards (OECD/BEPS).• The role will lead and prepare the...

  • Tax Specialist

    hace 2 días


    Ciudad de México Alcon A tiempo completo

    The main responsibilities include: • The Tax & Statutory accounting Specialist is responsible for supervise and drive all operational tax with the Tax advisor in Country.This role will ensure tax activities are aligned to Alcon global tax strategy and follows local laws as well as international standards (OECD/BEPS). • The role will lead and prepare the...

  • Clinical Trial Coord

    hace 4 semanas


    Ciudad de México Thermo Fisher Scientific A tiempo completo

    **Qualifications**: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). In some cases, an equivalency, consisting of a combination...