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

Bulgaria

Sofia

PSI CRO AG

<main><section class="job-section" id="st-companyDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Company Description</h2></div><div class="wysiwyg"><p>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&nbsp;3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.</p></div></section><section class="job-section" id="st-jobDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Job Description</h2></div><div class="wysiwyg" itemprop="responsibilities"><p><u>Actual position's title: Clinical Data Scientist</u></p><p>Reporting to the Clinical Data Science Manager, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department.</p><p><u>Hybrid work in Sofia</u></p><ul><li>Participate&nbsp;in selection of the Risk-Based Monitoring (RBM) system and provide&nbsp;relevant training to the project team and/or Sponsor</li><li>Set up and maintain RBM systems, collaborating with the Central Monitoring Manager</li><li>Manage complex datasets from multiple sources, including data extraction, transformation, and loading into PSI data platform</li><li>Program and produce data listings, tables, and figures for Clinical Data Reviewers and Central Monitoring Managers</li><li>Calculate Key Risk Indicators and Quality Tolerance Limits, applying advanced analytical techniques to identify data trends for Centralized Monitoring</li><li>Collaborate cross-functionally to identify study challenges and develop data solutions using advanced analytics</li><li>Communicate data findings and solutions to stakeholders effectively</li><li>Contribute to the development of databases, software products, processes, and Quality System Documents for Centralized Monitoring</li></ul></div></section><section class="job-section" id="st-qualifications"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Qualifications</h2></div><div class="wysiwyg" itemprop="qualifications"><p><strong>Must have:</strong></p><ul><li>Degree in Data Science, Mathematics, Statistics, Computer Science or equivalent</li><li><strong>Minimum 4 years of SAS programming experience in Clinical/Pharmaceutical domain</strong></li><li>At least 2 years of experience in data engineering area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling, testing, validation and analysis</li><li>Full professional proficiency in English and Bulgarian</li><li>Strong analytical and logical thinking</li><li>Communication and collaboration skills</li></ul><p><strong>Nice to have:</strong></p><ul><li>SAS programming experience with SQL programming</li><li>SAS programming experience in Biostatistics&nbsp;Department&nbsp;or Clinical Programming Department</li><li>Knowledge&nbsp;of CDISC SDTM</li><li>Experience with CluePoints RBM system</li><li>Knowledge of statistical methods&nbsp;and techniques for analyzing data</li><li>Experience&nbsp;using Machine Learning technics and&nbsp;products testing and validation</li></ul></div></section><section class="job-section" id="st-additionalInformation"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Additional Information</h2></div><div class="wysiwyg" itemprop="incentives"><p><strong>What we offer:</strong></p><ul><li>We value your time so the recruitment process is as quick as 3 meetings</li><li>We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program</li><li>You'll have excellent working conditions - spacious and modern office in convenient location, and friendly, supportive team who love to hang out together&nbsp;</li><li>You'll have&nbsp;permanent work agreement at a stable, privately owned company</li><li>We care about our employees - aside from competitive salary, you'll have good work-life balance with flexible working hours and additional days off, life and medical insurance, sports card, lunch card&nbsp;</li><li>We're constantly growing which means&nbsp;opportunities for personal and professional growth&nbsp;</li></ul><p>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.</p><p><u><strong>Please submit your CV in English</strong></u></p></div></section></main>

Full Time

Regular employment

Data Science and Analytics

SAS Programmer in Clinical Trials

Bulgarian

English

Communication Skills

Data Analysis

DBMS

Logical Thinking

Machine Learning

Monitoring

Risk Management

Statistical Analysis

Validation

ETL tools

Database Development

Data Warehouse

Analytics

SDLC Methodologies

Data Modeling

Analytical thinking

Product knowledge

Domain Driven Design

Data Engineering

Collaboration skills

Hybrid

<main><section class="job-section" id="st-companyDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Company Description</h2></div><div class="wysiwyg"><p>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 stronger study delivery.</p><ul></ul></div></section><section class="job-section" id="st-jobDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Job Description</h2></div><div class="wysiwyg" itemprop="responsibilities"><p>Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.</p><p>In this role you will:</p><ul><li>Act&nbsp;as the main line of communication between the Sponsor or CRO and the site.</li><li>Ensure&nbsp;response to feasibility questions are provided in due time.</li><li>Assist&nbsp;in scheduling and preparation for all types of monitoring visits at the medical institution/research center.</li><li>Be present and available to respond to monitors during&nbsp;all types of monitoring visits conducted at the medical institution.</li><li>Track&nbsp;patient enrollment and actively support&nbsp;the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.</li><li>Maintain&nbsp;study specific and general tracking of documents at the site level.</li><li>Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.</li><li>Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations.</li><li>Proper handling, accountability and reconciliation of investigational products and clinical supplies.</li><li>Collect, handle&nbsp;and maintain&nbsp;all site-specific regulatory documents as needed.</li><li>Facilitate&nbsp;and support the contract and budget negotiations at the site level.</li><li>Support&nbsp;Investigator and Site payments and processes as needed.</li><li>Schedule&nbsp;and/or perform&nbsp;study procedures as per study requirements and delegation of responsibilities.</li><li>Prepare&nbsp;for and participate&nbsp;in onsite study audits or regulatory agency inspections.</li></ul></div></section><section class="job-section" id="st-qualifications"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Qualifications</h2></div><div class="wysiwyg" itemprop="qualifications"><ul><li>College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.</li><li>Prior experience in coordinating clinical trials on site</li><li>Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.</li><li>Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.</li><li>Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.</li></ul></div></section><section class="job-section" id="st-additionalInformation"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Additional Information</h2></div><div class="wysiwyg" itemprop="incentives"><p>If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.</p></div></section></main>

Healthcare and Therapy

Clinical Trial Site Coordinator

Auditing

Contract Negotiation

Control Systems

Healthcare Management

Inspection

Problem Solving

Product Management

Project Coordination

Regulations

Reporting

Supply Chain Management

Support

Time Management

Networking protocols

Processing payments

Business Communication

Adaptability

 budget management

On-site

<main><section class="job-section" id="st-companyDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Company Description</h2></div><div class="wysiwyg"><p>We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.&nbsp; A dynamic, global company founded in 1995, we bring together more than 2,900 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.</p></div></section><section class="job-section" id="st-jobDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Job Description</h2></div><div class="wysiwyg" itemprop="responsibilities"><p>As a Clinical Supplies Specialist, you will be contributing&nbsp;to the smooth conduct of global clinical trials, ensuring&nbsp;high-quality clinical supplies flow, and be involved in something new, outstanding and challenging.</p><p><u>Hybrid role Sofia, Bulgaria</u></p><p>Responsibilities:</p><ul><li>Clinical study supplies receipt, inventory and storage</li><li>Maintenance of study supplies inventory system and database</li><li>Places purchasing/rent orders to suppliers of medication and equipment to be sent to investigative sites</li><li>As part of this role, you will be responsible for purchasing commercial medication and ancillary supplies to support clinical trials</li><li>You will work closely with global project teams to ensure timely and efficient delivery of medication for our patients</li><li>Communication with company departments regarding clinical supplies shipment, receipt, distribution and destruction</li><li>Supports vendor selection, qualification, and contracting for clinical supply of marketed products</li><li>Reviews project-specific study supplies and relabelling&nbsp;plans</li><li>Communication with company departments regarding clinical supplies shipment, receipt, distribution and destruction</li></ul></div></section><section class="job-section" id="st-qualifications"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Qualifications</h2></div><div class="wysiwyg" itemprop="qualifications"><ul><li>College/University degree</li><li>Life Sciences or Pharmaceutical degree</li><li>At least three years overall industry experience</li><li>Prior administrative/clerical experience is a plus</li><li>Native Bulgarian and Intermediate English, spoken and written</li><li>Proficiency in standard MS Office applications</li><li>Strong communication and collaboration skills</li><li>Detail-oriented mindset</li><li>Desire and ability to learn</li></ul></div></section><section class="job-section" id="st-additionalInformation"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Additional Information</h2></div><div class="wysiwyg" itemprop="incentives"><p>We offer:</p><ul><li>Excellent working conditions</li><li>Extensive training and friendly team</li><li>Opportunities for personal and professional growth</li></ul><p>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.</p><p>Please provide your CV in English.&nbsp;</p></div></section></main>

Logistics and Transportation

Clinical Supplies Specialist

Databases

Detail Management

Distribution

Inventory Management

Storage

Test Plans

Vendor Management

Vendors

Visual planning

Purchase orders

MS Office Tools

Demand planning

Purchasing Planning

Product delivery

Purchasing experience

<main><section class="job-section" id="st-companyDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Company Description</h2></div><div class="wysiwyg"><p>At Milestone One, we’re building the foundation for something big — and lasting. As we prepare for rapid growth and expansion into new services, we’re looking for passionate, driven individuals who want to help shape the future of our digital and operational landscape. This is your opportunity to join at the start and help us reach the many milestones ahead.</p><ul></ul></div></section><section class="job-section" id="st-jobDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Job Description</h2></div><div class="wysiwyg" itemprop="responsibilities"><p>We are seeking a Lead Developer to oversee the design, development, and delivery of internal applications, process automations, dashboards, and SharePoint-based solutions. You will play a key role in ensuring all systems are secure, scalable, and fully compliant with regulatory requirements including 21 CFR Part 11, ALCOA++, GDPR, NIS2, and EMA guidelines.</p><p>As the technical lead, you will guide a small but growing development team, define development standards, and work closely with business stakeholders to transform requirements into robust, compliant, and efficient solutions.</p><p><strong>Responsibilities</strong></p><ul><li>Lead the architecture, development, and lifecycle management of Power Platform (Power Apps, Power Automate, Power BI) and SharePoint Online solutions.</li><li>Design and maintain secure, compliant SharePoint environments for collaboration, document control, and quality management.</li><li>Implement development practices that meet key regulatory frameworks: 21 CFR Part 11, ALCOA++, GDPR, NIS2, and EMA.</li><li>Ensure solutions are scalable, maintainable, and capable of supporting a fast-growing business.</li><li>Collaborate closely with stakeholders across Compliance, IT, and Business teams to gather requirements and deliver impactful solutions.</li><li>Provide technical leadership and mentorship to the development team.</li><li>Continuously explore Microsoft 365 capabilities to improve solution delivery and compliance.</li></ul></div></section><section class="job-section" id="st-qualifications"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Qualifications</h2></div><div class="wysiwyg" itemprop="qualifications"><ul><li>Proven experience leading development using Power Platform and SharePoint in regulated environments.</li><li>Strong working knowledge of regulatory compliance: 21 CFR Part 11, ALCOA++, GDPR, NIS2, EMA.</li><li>Deep expertise in Microsoft 365 development and integration (Power Platform, SharePoint Online, Azure, Dataverse).</li><li>Strong leadership and collaboration skills.</li><li>Experience developing in environments with established Master Data Management (MDM) practices is a plus.</li><li>Background in Life Sciences, Healthcare, or another regulated industry is strongly preferred.</li></ul></div></section><section class="job-section" id="st-additionalInformation"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Additional Information</h2></div><div class="wysiwyg" itemprop="incentives"><p><strong>Why Join Us?</strong></p><ul><li>Be a foundational part of Milestone One’s journey.</li><li>Lead impactful development work that directly supports business growth and regulatory excellence.</li><li>Join a forward-thinking, collaborative team.</li><li>Competitive compensation and benefits.</li><li>Shape the future of our digital operations.</li></ul></div></section></main>

IT & Technology

Lead Developer – Power Platform, SharePoint & Automation

Leadership

SharePoint

Azure

Mentoring

Power BI

GDPR

PowerAutomate

<main><section class="job-section" id="st-companyDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Company Description</h2></div><div class="wysiwyg"><p>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 close to 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.</p></div></section><section class="job-section" id="st-jobDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Job Description</h2></div><div class="wysiwyg" itemprop="responsibilities"><p>As a&nbsp;Clinical Research Associate II,<strong><em>&nbsp;</em></strong>you will work on the frontline of communication with project stakeholders, ensuring timelines, targets, and standards of clinical research projects in a variety of therapeutic indications.&nbsp;You will build and maintain relationships with clinical sites and investigators.&nbsp;You will focus on subjects’ rights, safety and well-being and quality of data compliance.</p><p><u>Hybrid role in Sofia, Bulgaria</u></p><p>Your responsibilities will include:</p><ul><li>Preparation, conduct, and reporting of all types of monitoring visits</li><li>Supporting quality control, such as compliance monitoring and reports review</li><li>Contact for clinical investigators, vendors and support services in regard to study progress</li><li>Delivering training of investigators, site staff and project teams</li><li>Be involved in site identification process and feasibility research</li><li>Support to Regulatory Affairs in procurement of site regulatory documents</li><li>Preparation and delivering of presentations at Investigator’s Meetings</li><li>Maintenance of study-specific automated tracking systems</li><li>Preparation for and attendance at company’s audits; resolution of audit findings</li></ul></div></section><section class="job-section" id="st-qualifications"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Qualifications</h2></div><div class="wysiwyg" itemprop="qualifications"><ul><li>Degree in Life Sciences (or similar),&nbsp;or an equivalent combination of education, training &amp; experience</li><li>1&nbsp;year and a half&nbsp;of independent on-site monitoring experience in Bulgaria, ideally on&nbsp;multiple projects at a time&nbsp;</li><li>Experience in all types of monitoring visits in Phase II and/or III</li><li>Native Bulgarian and full working proficiency in English</li><li>Experience supporting Oncology studies is beneficial, but not essential</li><li>Proficiency in MS Office applications</li><li>Ability to plan, multitask and work in a dynamic team environment</li><li>Communication, collaboration, and problem-solving skills</li><li>As you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel.&nbsp;</li></ul></div></section><section class="job-section" id="st-additionalInformation"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Additional Information</h2></div><div class="wysiwyg" itemprop="incentives"><p>This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.</p></div></section></main>

Science and Research

Clinical Research Associate II

Collaboration

Driving

Microsoft Office

Multitasking

Planning

Quality Control

Training

Switzerland

<main><section class="job-section" id="st-companyDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Company Description</h2></div><div class="wysiwyg"><p>At <strong>Milestone One</strong>, we’re transforming access to clinical trials by expanding research site networks and fostering strategic partnerships with medical institutions. Our mission is to <strong>connect patients, physicians, and sponsors</strong> in a seamless ecosystem that accelerates breakthrough treatments.</p><p>With over <strong>30 years of global experience</strong>, we are a team of industry experts dedicated to quality, innovation, and collaboration. As our <strong>Operations Manager</strong>, you’ll play a key role in driving our business expansion through leading the local team and building strong, long-term partnerships with clinical research organizations and medical institutions.</p><ul></ul></div></section><section class="job-section" id="st-jobDescription"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Job Description</h2></div><div class="wysiwyg" itemprop="responsibilities"><ul><li>Assesses feasibility of research protocols based on knowledge and experience and in accordance with designated criteria to select the most suitable studies for the clinical site.&nbsp;&nbsp;</li><li>Supervises the conduct of clinical trials in accordance with ICH GCP, applicable regulations, procedures, and protocols, by monitoring the safety of patients, completeness of research documentation and proper study conduct.&nbsp;</li><li>Monitors individual stages of budget negotiations and research timelines.&nbsp;</li><li>Manages the team of Lead Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and any other available tools to ensure satisfactory performance of the MO1 team.&nbsp;</li><li>Ensures continuous improvement and standardization of the research process, its continuity and consistency with ICH GCP, regulations, procedures and research protocols by co-creating operational procedures, templates, guidelines related to the work of medical staff and the site in clinical studies.&nbsp;</li><li>Creates a work culture environment that promotes process transparency, high performance and openness.&nbsp;</li><li>Manages and supervises the teams’ work, ensuring the development of individual team members through regular, open feedback, periodic support meetings, providing training and guidance.&nbsp; Provides performance evaluation in accordance with the employee evaluation system to maintain motivation and commitment at work.&nbsp;&nbsp;</li><li>Supervises and participates, when necessary, in audits and inspections, supports the Milestone One team and the medical team at the site by ensuring a reliable and smooth audit process.&nbsp;</li><li>Build&nbsp;and sustain&nbsp;long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).</li><li>Support network development activities by active promotion of Milestone One brand by acquiring new clinics and new medical institutions to the network.</li></ul></div></section><section class="job-section" id="st-qualifications"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Qualifications</h2></div><div class="wysiwyg" itemprop="qualifications"><ul><li>University degree in life sciences</li><li>Minimum 5 years of a clinical on the job experience, in a leadership position at a CRO or SMO&nbsp;</li><li>Fluent use of local language, at least C1 level of English&nbsp;</li><li>Proficiency in MS Office&nbsp;</li><li>Valid driver’s license&nbsp;</li><li>Excellent communications and presentation skills</li><li>Excellent Management Skills&nbsp;</li><li>Effective problem solving and result oriented&nbsp;</li><li>Accountable&nbsp;</li><li>Team Leadership Skills&nbsp;</li><li>Induction training in SOPs and administration practices for SEO Managers. On the job training under supervision of Project Manager Global or designated person&nbsp;</li><li>Sales skills and client engagement experience are considered a strong plus</li></ul></div></section><section class="job-section" id="st-additionalInformation"><div><p class="googlejobs-paragraph--empty"></p><h2 class="title">Additional Information</h2></div><div class="wysiwyg" itemprop="incentives"><p>Accelerate your career with Milestone One!</p></div></section></main>

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