Site Solutions Executive Level 2

Premier Research International; Indien; Vor Ort; INR 350.000 - 600.000; Vollzeit

Zusammenfassung

Premier Research International in India seeks a Site Solutions Executive Level 2 to coordinate clinical trial activities at the site, ensuring adherence to protocol, GCP guidelines, and local regulations. You will support the PI and site team to meet sponsor and regulatory criteria and help roll out improved site processes.

The role requires a degree in clinical/biological/mathematical sciences or a related field, plus strong English communication, interpersonal and organizational skills.

Qualifikationen

• Bachelor’s or Master’s degree in clinical/biological or mathematical sciences or a medical/dental/nursing qualification; exceptions require 4+ years at clinical research sites.
• Excellent communication in English and at least one local Indian language.
• Excellent interpersonal, coordination and organizational skills.
• Attention to detail and data accuracy in clinical trials; ethical and patient-safety focus.
• Familiarity with computers and standard office tools.

Aufgaben

• Coordinates and facilitates all clinical trial activities at site in compliance with protocol, GCP guidelines and local regulations.
• Supports PI and site study team to ensure trials meet sponsor/regulator criteria.
• Reviews site processes, identifies gaps, and supports rollout of site processes.
• Performs timely data entry of Case Report Forms (CRF) or eCRF with PI/Investigator.
• Maintains clinical trial documents at site including Trial Master File.
• Prepares for, facilitates and aids site initiation, monitoring and close-out visits and inspections.
• Reports site performance metrics at predefined frequency.

Kenntnisse

English communication

Local Indian language

Interpersonal skills

Coordination

Problem solving

Attention to detail

Ausbildung

Clinical/biological/mathematical sciences degree

Tools

Office tools

Jobbeschreibung

Premier Research is looking for a Site Solutions Executive Level 2 to join our India Operations team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

Your ideas influence the way we work, and your voice matters here.

As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What you'll be doing:

• Coordinates and facilitates all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations;


• Supports Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators,


• Reviews the site processes, identifies gaps and supports roll-out of site processes.


• Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator


• Maintaining clinical trial-related documents at site including Trial Master File.


• Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections.


• Reporting site-performance metrics at pre-determined frequency.

What we are looking for:

• A Bachelor's or Master's degree in clinical, biological or mathematical sciences or related fields, or a medical or dental degree or a nursing qualification; Exceptions to this would require a minimum of 4 years of experience of working at clinical research sites.


• Good oral and written communication skills in English and at least one local Indian language


• Excellent interpersonal skills


• Good coordination and organizational skills and also problem-solving and analytical skills


• Attention to detail and documentation and conscious of the importance of time and data accuracy in the clinical trial context


• Conscious of ethical and scientific requirements and of patient-safety and patient-rights in the clinical trial context


• Familiarity with computer usage and office communication tools