Massimo Pokrajac

Managed end-to-end site activation activities for global clinical trials across multiple therapeutic areas.

Acted as the primary point of contact for investigative sites during start-up, ensuring timely document collection, regulatory submissions, and site readiness.

Oversaw the preparation, submission, and tracking of ethics and regulatory documents in compliance with ICH-GCP, local regulations, and sponsor requirements.

Coordinated closely with cross-functional teams including clinical operations, regulatory affairs, and contract specialists to drive project timelines.

Identified potential site activation risks and implemented mitigation strategies to ensure timely start-up deliverables.

Provided regular status updates and metrics reporting to project managers and stakeholders.

Supported process improvement initiatives by mentoring junior team members and contributing to standard operating procedure (SOP) revisions.

Ensured high-quality documentation and audit-readiness across all assigned projects.

While working as a Multilingual Medical Information Specialist my responsibilities were the following:

• Responded to over 100 technical inquiries weekly regarding designated pharmaceutical products, ensuring 95% customer satisfaction.

• Ensured 100% compliance with client-specific Working Practices by tailoring responses to meet pharmaceutical regulatory standards.

• Identified and reported adverse events and defective products using MedDRA, Veeva and other regulatory tools, handling 30+ cases per month.

• Translated over 100 documents from English to Italian, achieving 98% translation accuracy in quality checks over a six-month period.

• Logged and documented over 100 inquiries into the CRM system, ensuring 100% data accuracy and adherence to timelines.

• Managed confidential patient data for over 100 inquiries, maintaining strict compliance with GDPR and HIPAA data privacy regulations.

• Monitored and ensured 100% compliance with EMA and FDA regulations, resulting in zero non-compliance issues during audits.

• Conducted quality checks on 50+ Adverse Events and Product Quality Complaints monthly, improving reporting accuracy by 15% .

While working as a PV Coordinator my responsibilities were the following:

• Performed reporting's of Aggregate reports to Regulatory Authorities (Ras), Ethics Committees (ECs), Institutional Review Boards (IRB) and Investigators

• Performed aggregate reporting electronically to:

• European Medicines Agency (EMA) via EudraLink and CTIS

• WEB Trader and/or Food and Drug Administration (FDA)

• Common European Submission Portal (CESP)

• Ensayos Clinicos con Medicamentos (ECM)

• Medicines & Healthcare products Regulatory Agency (MHRA)

• My Connexus portal Submissions

• via courier (DHL)

• Via E-mail

• Led a submission team of 5, coordinating efforts that reduced submission time by 20%, ensuring all reports met regulatory deadlines while maintining a high KPI of 97% .

• Tracked and archived 100+ Aggregate reports monthly, improving document retrieval speed by 30% through enhanced tracker organization.

• Prepared invoice data for over 20 submissions weekly, ensuring accuracy and timeliness in financial documentation and submissions.

• Maintained Submissions mailbox.

• Participated in Audits and Inspections.

• Trained 3 new Pharmacovigilance team members, improving team adherence to SOPs by 25% within their first month of onboarding.

• Maintained Medical Writing team's tracker.

• Organised envelopes for signing of documents through DocuSign.

• Provided regulatory support for medical writing teams in CTA-related documentation.