PSI CRO AG

• Track database set-up, testing, maintenance and data entry • Communicate with clients, project teams and vendors on data management matters • Review study documents, design and develop project specific guidelines and instructions • Design eCRF, Data Management and Data Validation Plans and test EDC databases • Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation • Code medical data • Track and report metrics leading to database lock • Coordinate the processing, dispatch and archiving of CRFs/queries • Maintain Clinical Data Management working files • Perform database QC checks, prepare and attend audits • Train site staff and project teams on CRF completion and data management topics

• Track database set-up, testing, maintenance and data entry • Communicate with clients, project teams and vendors on data management matters • Review study documents, design and develop project specific guidelines and instructions • Design eCRF, Data Management and Data Validation Plans and test EDC databases • Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation • Code medical data • Track and report metrics leading to database lock • Coordinate the processing, dispatch and archiving of CRFs/queries • Maintain Clinical Data Management working files • Perform database QC checks, prepare and attend audits • Train site staff and project teams on CRF completion and data management topics

Role Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in United States Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments Qualifications - Medical Doctor degree required - US Board Certification in psychiatry required - Experience as a practicing psychiatrist (minimum of 10 years) - Clinical Research experience preferred - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented Benefits - As part of PSI's Medical Monitoring team, you will join our international group of medical professionals - Build a career on the frontline of medical science - Use your knowledge and expertise to help bring new medications to patients that need them

Role Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Canada. Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions. - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions. - Monitors trial participant safety. - Participates in trial participant recruitment boost and retention activities. - Presents on medical matters at kick-off and investigator meetings. - Trains trial team in the therapeutic area and medical aspects of the protocol. - Develops and reviews trial-specific documents within the scope of medical monitoring. - Manages ongoing trial risks related to medical monitoring. - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial. - Reviews protocol deviations. - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues. - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request). - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s). - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases. - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs). - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable. - Prepares for and participates in trial audits, follows up on audit findings. - Participates in feasibility assessment of potential and ongoing trials in the country/region. - Participates in bid defense meetings and other interactions with clients. - Acts as a medical expert and provides therapeutic expertise to other PSI departments. Qualifications - Medical Doctor degree required. - Canada Board Certification in psychiatry required. - Experience as a practicing psychiatrist (minimum of 10 years). - Clinical Research experience preferred. - Proficiency with MS Office applications. - Communication, presentation and analytical skills. - Problem-solving, team and detail-oriented. Benefits - As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them. - Compensation: CAD 170,000 - CAD 185,000 yearly.

Role Description The Manager Operations is responsible for overseeing the operational conduct of clinical trials at contracted medical institutions within a defined country or region in accordance with Milestone One contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This position plays a key role in staff development, process improvement, and continuous operational excellence. SCOPE OF RESPONSIBILITIES - Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution. - Monitors the progress of budget negotiations and study activation timelines to support timely site readiness. - Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team. - Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures. - Creates a work culture environment that promotes process transparency, accountability, and continuous learning. Qualifications - Associate degree in life sciences or similar. Business Management degree or certification is a plus. - Certifications ICH GCP Training - Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred. - Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out. - Fluent use of English - Proficiency in MS Office - Valid category B driver’s license - Excellent communications skills - Excellent management skills, experience managing remote staff preferred. - Effective problem solving and result oriented - Accountable - Team leadership skills Benefits - Compensation: USD 115000 - USD 150000 yearly 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 stronger study delivery.

• Manages the full cycle recruitment process on a regional scale • Develops, posts and maintains job advertisements and recruitment materials tailored to the position and media platforms • Proactively sources potential candidates via job boards and social media • Organizes, conducts, and reports on first stage interviews and testing of job candidates (if applicable) • Ensures ongoing maintenance of Applicant Tracking System • Develops and maintains compensation and benefits benchmark for each job position; in conjunction with Hiring Manager and the HR Team • Develops candidate pipelines for open and future opportunities within Milestone One • Partners with hiring managers to understand their business and recruitment needs • Acts as a point of contact and builds relationships with candidates during the selection process, maintaining a positive reputation of the company as an employer

• Oversee the planning and execution of international meetings • Coordinate logistics and manage vendors • Support budgets, travel, compliance, and post‑event processes • Ensure smooth, well-organized events • Communicate with internal and external clients on meeting planning, budgeting, organization, conduct and follow-up • Conduct market research regarding destinations/venues for project meetings • Oversee travel arrangements for the meetings attendees • Review contracted vendor invoices and the payment process • Provide data related to Investigators’ Meetings and other project meetings expenses to the finance team • Oversee investigators’ reimbursement payments • Maintain online registration system • Ensure compliance with country-specific policies regarding interactions with Health Care Professionals • Estimate meeting costs for potential or existing contracts

Role Description The Manager Operations is responsible for overseeing the operational conduct of clinical trials at contracted medical institutions within a defined country or region in accordance with Milestone One contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This position plays a key role in staff development, process improvement, and continuous operational excellence. SCOPE OF RESPONSIBILITIES - Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution. - Monitors the progress of budget negotiations and study activation timelines to support timely site readiness. - Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team. - Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures. - Creates a work culture environment that promotes process transparency, accountability, and continuous learning. Qualifications - Associate degree in life sciences or similar. Business Management degree or certification is a plus. - Certifications ICH GCP Training - Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred. - Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out. - Fluent use of English - Proficiency in MS Office - Valid category B driver’s license - Excellent communications skills - Excellent management skills, experience managing remote staff preferred. - Effective problem solving and result oriented - Accountable - Team leadership skills Benefits - Compensation: USD 115,000 - USD 150,000 yearly 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 stronger study delivery.

• Line manage, coach, mentor, and develop Clinical Research Associates across multiple experience levels. • Manage hiring, onboarding, performance management, and professional development activities. • Oversee resource allocation, workload planning, and utilization across clinical trials. • Collaborate with Project Managers and cross-functional teams to ensure successful study delivery. • Monitor staff performance and support operational efficiency through established departmental metrics. • Implement departmental quality controls and contribute to the development and continuous improvement of quality systems and processes. • Prepare for and participate in internal audits, sponsor audits, and regulatory inspections. • Support trial execution by resolving operational challenges and facilitating communication between project teams and investigational sites. • Participate in feasibility assessments for new and ongoing studies. • Support business development activities, including client meetings, networking events, and operational discussions, as needed.

Role Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Brazil Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments Qualifications - Medical Doctor degree required - Experience as a practicing Gastroenterologist (minimum of 10 years) - Clinical Research experience preferred - Full working proficiency in English and Portuguese - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented Additional Information As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.