Country Start Up Specialist

hace 9 horas


Buenos Aires, Argentina Medpace, Inc. A tiempo completo

Job Summary:
As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands on experience to enable you to develop a career in clinical research.

Responsibilities:

- Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
- Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
- Conduct quality control of documents;
- Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
- Perform other tasks as needed.

Qualifications:

- Bachelor's degree is required (preferably in a Life Sciences field) and experience in study start up preferred;
- Excellent organizational and prioritization skills;
- Knowledge of Microsoft Office;
- Great attention to detail and excellent oral and written communication skills; and
- Fluency in spoken and written 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_


  • Start-up Specialist

    hace 9 horas


    Buenos Aires, Argentina Labcorp A tiempo completo

    Role Description Study-Start-Up/QC Specialist: Purpose: Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to...


  • Buenos Aires, Argentina FullStack Labs A tiempo completo

    Regulatory & Start Up Specialist We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! What You'll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and...


  • Buenos Aires, Argentina Labcorp A tiempo completo

    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...


  • Buenos Aires, Argentina Baker Hughes A tiempo completo

    Regulatory & Start Up Specialist We are currently looking for a Regulatory & Start Up Specialist to join our team in a Home Based role! Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and...


  • Buenos Aires, Argentina BairesDev A tiempo completo

    Country Approval Specialist – PPD PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose — to improve health. Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our...


  • Buenos Aires, Argentina Medpace, Inc. A tiempo completo

    Job Summary: Join Medpace in CABA! As a Regulatory Submissions Coordinator you will have the opportunity to work within the Regulatory Submissions team, supporting our many projects and gaining vital experience in the study start up and site activation process of clincial trials. You will be a productive member of the team, and will be mentored and...

  • Start Up Associate

    hace 5 días


    Buenos Aires, Argentina Labcorp A tiempo completo

    Primary contact and liaison with investigative sites during study maintenance and -when assigned-, site start-up activities, with responsibility for collection of the required investigator and regulatory essential documents to ensure EC/IRB submissions are made within the timelines agreed with project management and Start-up team. - Collect, track and...


  • Buenos Aires, Argentina Novartis A tiempo completo

    390776BR **SSO Study Start-Up Manager**: Argentina **About the role** 100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO The SSO Study Start-Up Manager is...


  • Buenos Aires, Argentina Wimbush & Associates, Inc. A tiempo completo

    Fsp - Regulatory and Start Up Specialist 2 - Arg IQVIA Job Overview The Regulatory & Start Up Specialist 2 will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines....

  • Start Up Manager

    hace 2 días


    Buenos Aires, Buenos Aires C.F., Argentina ICON plc A tiempo completo

    Start Up ManagerICON 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 developmentWe are currently seeking a Manager, Study Start-Up to join our diverse and dynamic...