Site Solutions Executive Level 2

Premier Research; Indien; Vor Ort; INR 600.000 - 800.000; Vollzeit

Benefits dieser Stelle

Corporate training opportunities

Zusammenfassung

Premier Research seeks a Site Solutions Executive Level 2 to join our India Operations team. You will support biotech, medtech, and pharma clients by coordinating clinical trial activities at the site while ensuring compliance withprotocols, GCP guidelines, and local regulations.

You will help PI and site teams to meet sponsor and regulatory criteria, review site processes for gaps, and facilitate site initiation, monitoring, and close-out visits with meticulous data entry and documentation.

Qualifikationen

• Experience in clinical research sites or similar settings.
• Proficient English communication and at least one local Indian language.
• Strong interpersonal and organizational skills with attention to data accuracy.
• Awareness of ethical, scientific, and patient-safety considerations in trials.
• Familiarity with computer usage and office software.

Aufgaben

• Coordinates and facilitates clinical trial activities at site per protocol and GCP.
• Supports PI and site team to meet sponsor/regulator criteria.
• Reviews site processes, identifies gaps, and supports roll-out.
• Performs timely data entry of CRF/eCRF in consultation with PI.
• Maintains Trial Master File and trial-related documents.
• Prepares for site initiation, monitoring, close-out visits, QA, sponsor visits.

Kenntnisse

Clinical trial coordination

GCP guidelines

Data entry/eCRF

Documentation

Ethics and patient safety

Communication (English + local)

Ausbildung

Bachelor's or Master's in clinical/biological/mathematical sciences, or medical/dental/nursing

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.
• The following key functions are required routinely:
• 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