Clinical Research Study Start-up Project Manager

hace 4 semanas

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 exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities:

- Efficiently manage and successfully execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits.

Qualifications:

- At least 4 years of experience in clincial research, preferably with a CRO, including at least 2 years of experience leading regulatory/start-up project teams;
- Knowledge and experience of Clinical Trial Applications within Latam;
- Strong oral and written communication skills;
- Team oriented approach and strong leadership skills; and
- Fluency in English.

Medpace Overview:
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?:
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

**Organic Growth**:
***Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.

**Perks (**
**_vary by location and position_**
**)**:

- On-site fitness center(s)
- Campus walking paths
- Company-sponsored social and wellness events
- Official Sponsor of FC Cincinnati
- Hybrid work-from-home options and flexible work schedule
- On-site Market Place
- Free and covered parking
- Discounts for local businesses
- On campus restaurants and banks coming soon

**Awards**:

- Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
- Recognized by Forbes as one of America's Best Mid-size Companies in 2021
- Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

**What to Expect Next**:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
- EO/AA Employer M/F/Disability/Vets_

  • Sso Study Start-up Manager

    hace 4 horas

    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...

  • Study Start-up Manager, Mexico

    hace 2 meses

    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...

  • Study Start Up Associate Ii

    hace 3 semanas

    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

    hace 1 mes

    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...

  • Clinical Project Manager

    hace 2 semanas

    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...

  • Clinical Project Manager

    hace 1 mes

    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

    hace 1 mes

    Ciudad de 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 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 organization: Accountability & Delivery,...

  • Study Start Up Associate I-biotech

    hace 7 días

    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,...

  • Clinical Project Manager

    hace 2 meses

    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,...

  • Specialist, Country Study Start Up

    hace 1 semana

    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 I

    hace 1 semana

    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 Ii

    hace 1 semana

    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 All Levels

    hace 1 semana

    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,...

  • Clinical Research Associate

    hace 2 semanas

    Ciudad de México MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Clinical Research Associate

    hace 2 semanas

    Ciudad de México MSD A tiempo completo

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Sr Clinical Research Asociate

    hace 2 semanas

    Ciudad de México MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...

  • Sr Clinical Research Asociate

    hace 2 semanas

    Ciudad de México MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager, the person ensures compliance of study conduct with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...

  • Clinical Research Associate

    hace 2 meses

    Ciudad de México ABBVIE A tiempo completo

    Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality...

  • Clinical Trial Manager Any Therapeutic

    hace 1 semana

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager any therapeutic area-assigned to client Mexico** 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...

  • Study Start Up

    hace 1 mes

    México Cidvid A tiempo completo

    Somos un holding mexicano con presencia global y con diversas líneas de negocio, pero con un fin en particular: PROCURAR LA SALUD Y EL BIENESTAR DEL SER HUMANO ¡ÚNETE A NUESTRO EQUIPO DE TRABAJO CÓMO STUDY START UP! El Study Start Up es el responsable de coordinar y dar seguimiento a los procesos de inicio y cierre de los estudios clínicos, atracción...