Sso Study Start-up Manager

hace 6 meses

Ciudad de México Novartis A tiempo completo

390215BR

**SSO Study Start-Up Manager**:
Mexico

**About the role**

Location: Ciudad de Mexico
On this role, you will be responsible for
The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager.
Key responsibilities:
Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio
- Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required
- Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)
- Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
- Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
- Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

Essential Requirements

**Education**:

- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable

Languages:

- Fluent in both written and spoken English, local language as needed

Experience/Professional requirement:

- Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports

You’ll receive: Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups and virtual self-development tools.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Ciudad de México

**Company/Legal Entity**

NOV CORPORATIVO MEX

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

  • Specialist, Country Study Start Up

    hace 3 meses

    Ciudad de México, CDMX AbbVie A tiempo completo

    **Company Description** **Job Description**: The Specialist, Country Study Start Up proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries. For studies that only involve one country, the Specialist, Country Study Start Up is responsible and...

  • Study Start Up Associate I

    hace 1 mes

    Ciudad de México, CDMX ICON Plc A tiempo completo

    Study 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 Ii

    hace 6 meses

    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...

  • Study Start Up Associate I

    hace 3 semanas

    Ciudad de México, CDMX ICON Plc A tiempo completo

    Study Start Up Associate I - Hybrid - Mexico City 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...

  • Specialist, Country Study Start Up

    hace 7 meses

    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...

  • Study Start Up Associate Ii

    hace 6 meses

    México ICON plc A tiempo completo

    At 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 fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Study Start Up Associate II Specialist

    hace 1 semana

    Ciudad de México, Ciudad de México Icon A tiempo completo

    At Icon, we are seeking a highly skilled Study Start Up Associate II to join our team. This role is an exciting opportunity for individuals who are passionate about delivering high-quality results in a fast-paced environment.Job Summary:The Study Start Up Associate II will be responsible for collecting, preparing, reviewing, approving, processing, and...

  • Ssu Cra

    hace 7 meses

    Ciudad de México Novartis A tiempo completo

    Site relationship management role to ensure sustainable trial start-up at Site. The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local...

  • Study Start Up Associate

    hace 2 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Study 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...

  • Area Study Start Up Lead

    hace 4 meses

    Ciudad de México, CDMX AbbVie A tiempo completo

    **Company Description** Purpose: The Area SSU Lead is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the...

  • Clinical Project Manager

    hace 7 meses

    Ciudad de México Novartis A tiempo completo

    392018BR **Clinical Project Manager**: Mexico **About the role** **Work Model**:Hybrid **Locality**:Ciudad de Mexico **About the Role**: 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...

  • Study Start Up Associate I-biotech

    hace 7 meses

    Ciudad de México ICON A tiempo completo

    At 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,...

  • Study Start Up Associate I

    hace 4 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Study Start Up Associate I (Regulatory Submissions) Mexico City - Hybrid Scheme 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...

  • Study Start Up Associate I

    hace 1 semana

    Ciudad de México ICON A tiempo completo

    As a Site Activation Partner/ Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive...

  • Regulatory Start Up Director for Clinical Trials

    hace 1 semana

    Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completo

    OverviewWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Mexico City. This is an exciting opportunity for individuals with experience in clinical trial management to grow their career and contribute to the success of Medpace.

  • Senior Clinical Trials Manager

    hace 1 semana

    Ciudad de México, Ciudad de México Healthcare Businesswomen's Association A tiempo completo

    Company OverviewThe Healthcare Businesswomen's Association is a leading organization in the healthcare industry, dedicated to empowering women to achieve their full potential.About the RoleWe are seeking an experienced Senior Clinical Trials Manager to join our team. This role will be responsible for contributing to the delivery of clinical trial...

  • Study Start Up Associate I

    hace 1 mes

    Ciudad de México, CDMX ICON Plc A tiempo completo

    Study 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...

  • Study Start Up Associate Ii

    hace 6 meses

    Ciudad de México ICON A tiempo completo

    As a Study Start Up Associate II you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting...

  • Country Study Operations Manager I

    hace 2 meses

    Ciudad de México, CDMX Pfizer A tiempo completo

    Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary...

  • Study Start Up Associate Ii

    hace 2 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Study Start Up Associate II (Site Activation Associate) - 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 At ICON, it’s our...