Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 dri…
Skills: IT Compliance, Risk Assessment, Audit Management, Document Control, Validation
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 dri…
Skills: IT Compliance, Risk Assessment, Audit Management, Document Control, Validation
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 dri…
Skills: Clinical Research Support, Document Management, TMF Review, Site Management, Regulatory Submissions
Company Description Milestone One to międzynarodowa organizacja wspierająca prowadzenie badań klinicznych, współpracująca z ośrodkami badawczymi i szpitalami w wielu krajach. Pracując z nami, zyskasz możliwość poznania b…
Skills: Clinical Trial Coordination, Patient Visit Planning, Medical Documentation Management, Stakeholder Collaboration, Data Entry
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 dri…
Company Description Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronge…
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Skills: Digital Marketing, Social Media Marketing, HubSpot, B2B Email Marketing, Lead Qualification
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800+ dr…
Skills: Site Management, Clinical Trial Management System (CTMS), Trial Master File (TMF), Electronic Data Capture (EDC), Vendor Management
King of Prussia, Pennsylvania, United States · Hybrid
Mid level
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800+ dr…
Skills: Clinical Research, Site Management, TMF Management, CTMS, EDC Completion
Senior Clinical Research Associate/ Clinical Research Associate II
Ankara, Ankara, Turkey · Hybrid
Mid level
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driv…
Skills: Clinical Monitoring, Site Management, Regulatory Affairs, Oncology, MS Office
Company Description At Milestone One, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, p…
Company Description At Milestone One, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, p…
Company Description At Milestone One, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, p…
Skills: Country Expansion Strategy, Investigator Site Networking, Clinical Operations Management, Stakeholder Management, Business Development
Company Description At Milestone One, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to connect patients, p…
Skills: Country Expansion Strategy, Investigator Site Networking, Clinical Operations Management, Stakeholder Management, Business Development
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 dri…
Skills: IT Compliance, Risk Assessment, Audit Management, Documentation, Change Control
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedica…
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedica…
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Clinical Data Management, eCRF Design, EDC Databases, Medical Coding, Data Validation
Company Description Milestone One is a Site Enabling Organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need, and our mission is to strengthen study delivery by connecting …
Skills: Clinical Trial Coordination, ICH-GCP, Site Activation, Patient Recruitment, EDC Systems
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Regulatory Affairs, Document Management, Clinical Research, MS Office, Multitasking
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Full-time
bachelor degree
Posted 14d ago
~40 hrs/week
Responsibilities
The role focuses on managing compliance for in-house IT systems and processes to ensure adherence to industry standards and internal policies. Key duties include creating IT documentation, participating in audits, and monitoring compliance with quality system documents.
Requirements
Candidates must hold a college or university degree and have prior experience in IT and compliance matters. Proficiency in English and strong meticulousness in handling documentation and processes are required.
Full job description
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
This role is hybrid - Based in Budapest
Job Description
In this role, you will focus on compliance matters related to in-house IT systems and processes. You will work with documents to make sure that PSI meets standards, industry requirements, and internal policies.
Create, update and process internal IT documents (change control, risk assessment, computer system inventory, validation, disaster recovery plan and the like)
Generate and provide IT documentation for internal and external audits
Take part in IT interviews during internal and external audits
Provide answers to IT questions from sponsors and during review of client and vendor agreements
Follow up on resolution of audit findings related to IT compliance
Support development and update of IT-related documents
Participate in the development of departmental QSDs
Monitor and ensure compliance with PSI QSDs, relevant laws, regulations and standards
Participate in regular risk assessments to identify potential vulnerabilities in IT systems and processes
Qualifications
College or University degree
Prior experience in IT and compliance matters
Meticulous, able to work with documents and processes
Full working proficiency in English
Communication skills and ability to build relationships at all levels
Additional Information
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.
Related keywords
IT ComplianceChange ControlRisk AssessmentComputer System InventoryValidationDisaster Recovery PlanInternal AuditsExternal AuditsQSDMedical ScienceIT SystemsRegulatory Compliance
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3