Regulatory And Start Up Manager - Poland

Iqvia

3+ years

Not Disclosed

Warsaw

10 Jan. 1, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: SSU Study Start-Up Manager
Company: IQVIA
Location: [Insert Location]

Job Overview

We are seeking a SSU Study Start-Up Manager to support and drive study start-up activities for assigned projects, ensuring timely and high-quality execution in compliance with local and international regulations. This role involves close collaboration with internal teams, local IRBs/IECs, and Health Authorities to prepare and finalize submission packages, manage timelines, and ensure a smooth start-up process.

Accountabilities

Collaborate with SSU Study Start-Up Team Lead, SSO Country/Cluster Head Portfolio, SSOP Portfolio Team Leads, and global study teams to ensure SSU timelines and deliverables meet country commitments.
Accountable for timely start-up activities from country allocation to achieving the Green Light milestone (ready to initiate site milestone) in assigned projects.
Ensure collaboration with local IRBs/IECs and Health Authorities, preparing necessary documentation and obtaining approvals for study start-up.
Prepare and finalize local submission packages for submission to IRBs/IECs, CTA Hub (Europe: EU-CTR), and Health Authorities, including subsequent amendments, IBs, DSURs, and CSRs.
Coordinate responses to deficiency letters from regulatory bodies, collaborating closely with local and global stakeholders.
Manage reportable events and notifications to IRBs/IECs and Health Authorities as necessary.
Ensure accuracy and quality of country TMF documents in study start-up, ensuring TMF inspection readiness.
Adhere to financial standards, ICH/GCP, IRB/IEC, Health Authority regulations, and SOP requirements during study start-up.
Implement innovative and efficient processes to improve study start-up timelines and quality.
Support study feasibility in collaboration with Feasibility Manager, Site Partnership Manager, and global study team.
Lead site selection in collaboration with Portfolio Team Lead and Clinical Project Manager (CPM) if already assigned.
Oversee local vendor selection and performance in satellite countries as needed.
Act as the main contact for quality/compliance issues during SSU phase, escalating as necessary.
Ensure sites are ready for Green Light, with all documentation in place for drug release.
Review and sign off on site Green Light, ensuring all documentation and approvals are in place.
Oversee local SSU team activities to achieve study start-up timelines and quality execution, proposing corrective actions as needed.
Lead and chair local SSU team meetings, ensuring alignment with global study team goals.
Lead the development of country site initiation and patient enrollment plans in collaboration with SSU CRA, CPM, and SSU Lead.

Qualifications

Bachelor's Degree in Life Sciences or a related field.
3+ years of clinical research experience in study start-up, regulatory submissions, and contract negotiations.
In-depth knowledge of clinical systems, procedures, and corporate standards.
Strong negotiation, communication, and organizational skills.
Ability to work independently and manage multiple tasks with attention to timelines and quality.
Knowledge of GCP/ICH and applicable regulatory guidelines.
Proven ability to establish and maintain effective working relationships with colleagues, clients, and external stakeholders.

About IQVIA

IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments.

Learn more at IQVIA Careers.

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Regulatory And Start Up Manager - Poland

Job Description

Job Overview

Accountabilities

Qualifications

About IQVIA

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