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Skills: Clinical research, Study start up, Regulatory affairs, Site activation, Risk assessment
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Full-time
bachelor degree
Posted 20h ago
~40 hrs/week
Responsibilities
The specialist drives and executes all start-up and maintenance activities for assigned clinical studies and sites. They are responsible for establishing activation plans, managing regulatory submissions, and ensuring audit readiness while maintaining performance metrics.
Requirements
Candidates should possess a bachelor's degree in a healthcare or scientific field and 1-2 years of clinical research experience. Proficiency in English and Polish, along with a working knowledge of ICH and GCP guidelines, is required.
Full job description
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Job Description
The role purpose: The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries.
Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads.
Primary RESPONSIBILITIES include but not limited to:
Ensuring successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites.
Establishing the country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs.
Proactively identifying and communicating issues impacting delivery and providing proposed solutions.
Attending regional/area start up calls and providing input for assigned sites/studies.
Collection of essential documents from sites and completing quality check (ALCOA).
Compiling and submitting ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting.
Coordinating with Regulatory and CTS on CA submission and approval status to assure alignment with other site activation requirements.
Collaborating with contract manager, CRA, Area CSM Lead as required to assure timely site activation.
Reviewing site and/or IRB/EC comments on ICFs and routing for approval by required functional areas.
Triggering clinical supply shipments.
Completing IP release activities and triggering IP shipment.
Issuing site green light letter and activating sites in IXRS.
Tracking all start up and maintenance related activities in Vault SSU as appropriate.
Maintaining local country and site intelligence database and EDLs in Vault.
Maintaining SSU performance metrics and KPIs for assigned sites/studies.
Providing start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
Ensuring audit/inspection readiness.
Ensuring compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
Participating in process improvement initiatives as required.
Qualifications
Bachelor's Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required.
A minimum of 1-2 years of clinical research experience and preferably 1+ years of study start up management experience for the designated region.
Experience working with remote/virtual teams.
Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives.
Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment.
Working knowledge of ICH and GCP guidelines and operational understanding of the country's regulatory environment.
Very good verbal and written communication in both English and Polish.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
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How many Science & Research jobs are open in Warsaw, Poland right now?
There are currently 385 open science & research positions in Warsaw, Poland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Warsaw, Poland?
Companies currently hiring include ICON plc, AstraZeneca, IQVIA, Bristol Myers Squibb, ICEYE, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Warsaw, Poland?
Yes — 277 of the 385 open science & research positions offer remote or hybrid work (76 remote, 201 hybrid).
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