Study Start Up Associate Ii

hace 3 semanas

México ICON A tiempo completo

The Study Start Up. Assocate II, collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.

Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

**What you will be doing**:
Recognize, exemplify and adhere to ICON’s values of Accountability and Delivery, Collaboration, Partnership and Integrity, which center around our commitment to Ownership.

Travel (approximately 5%) domestic and/or international. Anticipated activities may include attendance at kick-off, investigator or study team meetings.
- Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
- Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
- For specific projects, serve as the main point of contact with Sponsor, Project Manager, Clinical Trial Manager, Site Activation Lead, other functional leads and third parties. Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes.
- Assume responsibility as Subject Matter Expert (SME) as required.
- Coordination of all necessary translations required for any start-up documentation.
- Attend study team meetings as required.
- Other duties as assigned
- Responsible, as assigned, for one or more of the following tasks related to each of the key study start-up and/or maintenance activities:

- Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):

- Prepare, review and approve Global Master ICF templates for Sponsors, coordinate with Clinical Trial Manager and/or Site Activation Lead through to approval by Sponsors.
- Prepare, review and approve Country Master ICF templates inserting any required country elements, coordinate with Clinical Trial Manager and/or Site Activation Lead through to approval by Sponsors. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
- Proficiently negotiate Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
- Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.
Proficiently prepare, review and approve amended Global, Country and Site Specific amended ICFs.
- Negotiation and Execution of Clinical Trial Agreements (CTA):
Prepare, and review Study Site level budgets and contract templates and facilitate finalization and approval with the Sponsor, Legal, and any applicable internal personnel.
Proficiently negotiate CTAs, budgets and ancillary agreements.
Proficiently oversee all contractual documents and correspondence, including the facilitation of the indemnification process between Sponsor and Study Site.
- Establish and maintain effective and proactive communication with Study Sites, Sponsors and internal personnel regarding the status of budgets, contracts and any other contract-related documents.
- Ensure CTAs, budgets and ancillary agreements are negotiated within the Study specific agreed parameters and if not, appropriate approvals are obtained and documented.
As required, proficiently prepare, review and negotiate amendments to CTAs, budgets and ancillary agreements.
- Conduct second level quality control review of completed CTAs, budgets and ancillary agreements prior to execution.
- Serve as the internal liaison on study site budgets with respect to country needs and requirements.
- Forecast Budget and Clinical Trial Agreements execution timelines and ensures they are achieved; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.
Prepare, review and negotiate Master Service Agreements with sites.
- Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions: Proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
- Effective interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pe

  • Start-up & Regulatory Specialist

    hace 2 semanas

    Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    Start-up & Regulatory Specialist page is loaded Start-up & Regulatory Specialist Apply locations Mexico City Mexico time type Full time posted on Posted 30+ Days Ago job requisition id 2412781 As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides...

  • Regional Clinical Research Associate Level II

    hace 4 semanas

    México ESTERN Medical LLC A tiempo completo

    Regional Clinical Research Associate Level II & III Mexico Business Title Regional Clinical Research Associate Level II & III Requisition ID EM-R-CRA-1003 Job Category Regional Clinical Research Locations Job Description Job Summary: Assures the implementation of project plans as assigned. Site administration and site monitoring responsibility for...

  • Associate Ii

    hace 1 mes

    Ciudad de México Santander A tiempo completo

    Associate II Country: Mexico **WHAT YOU WILL BE DOING** 1. Mínimo 4 años de experiência en alguna área de expertis de de Santander Corporate & Investment Banking:Global transactional banking, Mercados, Global Debt Financial, ACPM, Corporate Investment Banking, COO. 2. Desempeñar funciones complejas y/o de especialización técnica elevada en alguna...

  • Country Approval Associate

    hace 4 semanas

    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. -...

  • Clinical Trial Associate Global

    hace 1 mes

    Ciudad de México IQVIA A tiempo completo

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Mex Associate Ii

    hace 1 mes

    Ciudad de México Santander A tiempo completo

    MEX Associate II Country: Mexico **WHAT YOU WILL BE DOING** 1. Mínimo 4 años de experiência en alguna área de expertis de de Santander Corporate & Investment Banking:Global transactional banking, Mercados, Global Debt Financial, ACPM, Corporate Investment Banking, COO. 2. Desempeñar funciones complejas y/o de especialización técnica elevada en...

  • Senior Site Activation Lead

    hace 1 mes

    Ciudad de México ICON plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Process Engineer/Vertical Start up

    hace 4 semanas

    México Mondelez International A tiempo completo

    Process Engineer/Vertical Start up page is loaded Process Engineer/Vertical Start up Apply locations Monterrey, Mexico Salinas, Mexico time type Full time posted on Posted 2 Days Ago job requisition id R-110796 Job Description Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It With Pride....

  • Clinical Project Manager

    hace 4 semanas

    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,...

  • Ssu & Regulatory Specialist Ii or Sr in Mexico

    hace 1 mes

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Job Description**: JOB TITLE: Site Start-Up & Regulatory Specialist II SELECT ONE: Clinical Solutions JOB CODE: 01022 REPORTS TO: Manager, Site Start-Up & Regulatory; or designee JOB SUMMARY Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for...

  • Lead CRA.

    hace 4 semanas

    Ciudad de México PSC Industries A tiempo completo

    i Ad · Clinical Project Manager · Clinical Project Manager · Location : CDMX · Hybrid Work ( 3 office days a week) · Role description · To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budg ... i Ad Lead Cra i Ad Clinical Project Manager · Clinical Project...

  • Quality Assurance Associate II

    hace 1 mes

    Ciudad de México Marken A tiempo completo

    Description Title: Quality Assurance Associate II  Job Purpose: The Quality Assurance Associate II (QAA II) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and...

  • Process Engineer/Vertical Start up

    hace 4 semanas

    México Mondelez España Galletas Production SLU A tiempo completo

    R-110796 |Monterrey, Mexico| 1 other location(s) available Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It With Pride. You will leadthe production operations in the Plant and delivering key performance targets(SQCDSM) in safety, quality, productivity, volumes, cost, sustainability,...

  • Site Activation Manager Ii

    hace 1 mes

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Site Activation Manager II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

  • Associate Artist Ii

    hace 1 mes

    Ciudad de México Activision A tiempo completo

    Job Title: Associate Artist II - Requisition ID: R020171 - Job Description: **Your Platform** Founded in 2002, Infinity Ward is the original studio behind the _Call of Duty_®_ franchise. The titles developed by Infinity Ward have won more than 200 "Game of the Year" awards and 100 "Editor's Choice" awards, among many other industry accolades. Some of our...

  • Clinical Operations Specialist

    hace 4 semanas

    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....

  • Site Relationship Partner I

    hace 4 semanas

    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...

  • Investigator Initiation Package Sr Associate

    hace 1 mes

    Ciudad de México Pfizer A tiempo completo

    JOB SUMMARY An Investigator Initiation Package (IIP) Sr Associate will ensure Pfizer maintains compliance with all requirements relating to release of investigational Product (IP) to clinical trial sites. Members of this team hold responsibility for verifying presence and consistency of required investigator related documents in the electronic Trial Master...

  • Ctry Approval Assoc

    hace 2 semanas

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job Description 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. Coordinates, under guidance,...

  • Ctry Approval Assoc

    hace 2 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...