Reg & Start Up Spec 2

hace 1 semana

Buenos Aires, Argentina IQVIA A tiempo completo

Join us on our exciting journey

IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare.

Job Overview
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. May also include maintenance activities.

Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.

**Qualifications**:

- Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Good negotiating and communication skills with ability to challenge, if applicable.
- Effective communication, organizational, and interpersonal skills.
- Ability to work independently and to effectively prioritize tasks.
- Ability to manage multiple projects.
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

ard.

  • Start-up Specialist

    hace 3 días

    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...

  • Start Up Manager

    hace 21 horas

    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...

  • Start Up Manager

    hace 4 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...

  • Fsp - Regulatory and Start Up Specialist 2 - Arg

    hace 5 días

    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 Associate

    hace 7 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...

  • Study Start Up Lead

    hace 1 día

    Buenos Aires, Argentina Novo Nordisk A tiempo completo

    Study Start up Lead **Category**:Clinical Development**Location**:Vicente Lopez, Buenos Aires, AR- Are you ready for a life-changing career at Novo Nordisk Argentina? Join us.- Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career - you grow professionally.**The Position**Activities and Responsibilities** -...

  • Senior Start-up Specialist

    hace 2 semanas

    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...

  • Regulatory & Start Up Specialist, Fsp

    hace 4 semanas

    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...

  • Study Start Up Manager

    hace 6 días

    Buenos Aires, Buenos Aires C.F., Argentina Medpace A tiempo completo

    Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-basedRegulatory Submissions Managerto join our Study Start Up team in Buenos Aires This position plays a key role in the study start up process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your...

  • Study Start-up Associate Senior

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Emmes Global A tiempo completo

    OverviewStudy Start-up Associate SeniorLATAM RemoteEmmes Group: Building a better future for us all.Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the...