PSI CRO

Manage and coordinate clinical trial activities across regions, ensure compliance, oversee site management, and lead study teams. | Requires 5+ years in clinical research, experience in oncology, study management skills, and proficiency in MS Office and MS Project. | 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 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. Job Description The Regional Project Lead manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level. Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents) Acts as primary or secondary project management contact for the project team and PSI support services in designated countries Performs study status review and progress reporting (if delegated by the Project Manager) Collects and reports project status updates for designated regions, both internally and externally Develops and updates project planning documents, essential study documents and project manuals/ instructions Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members Ensures that the project timelines and subject enrollment targets are met in designated countries Coordinates maintenance of study-specific and corporate tracking systems Coordinates site contractual startup and budget negotiations Establishes communication lines within the project team and supervises clinical project team members’ performance Identifies, escalates and resolves resourcing and performance issues Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager) Prepares presentations and conducts training of Investigators Ensures team compliance with project-specific training matrix Performs field training of Monitors tailored to the project needs Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings Coordinates conduct of supervised monitoring visits Reviews site visit reports and ensures monitoring and reporting standards are met Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications Oversees the safety information flow and participates in feasibility research Reviews/approves project related expenses and timesheets (if delegated by the Project Manager) Qualifications College/University degree in Life Sciences or an equivalent combination of education, training & experience is required Prior experience in Clinical Research (minimum 5 years) and on-site monitoring is required Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required Experience in Oncology is required Experience in GI is preferred Full working proficiency in English Proficiency in MS Office applications, including MS Project Communication, presentation and customer-service skills Ability to negotiate and build relationships at all levels Team building, leadership and organizational skills Additional Information Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

The Associate Medical Writer is responsible for writing, editing, and reviewing clinical documentation, including informed consent forms and clinical study reports. They also perform quality control reviews and collaborate with teams to develop patient safety narratives. | Candidates should have a college or university degree in biomedical or life sciences, or equivalent experience, with a minimum of 2 years in medical or regulatory writing. Prior experience in the pharmaceutical or biotechnology industry is also required. | 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 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them. Job Description Writes, edits, and reviews documents, including informed consent forms, patient information, and other project-specific clinical documentation. Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives. Collects and tracks documents for CSR appendices, in support of the Quality Control Associates. Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates. Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks. Collaborates with the Process Improvement narrative automation team to develop patient safety narratives. Qualifications College or university degree, preferably a Bachelor's or Master's degree in biomedical or life sciences fields, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years of experience in medical and/or regulatory writing and related tasks. Minimum 2 years of corresponding industry experience working with clinical documentation and data Prior pharmaceutical, biotechnology, or contract research organization experience Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of documents Basic knowledge of electronic Common Technical Document (eCTD) requirement Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Coordinate and monitor clinical trial sites, manage project timelines, ensure compliance and data integrity, train and mentor monitors, and support regulatory submissions. | Minimum 4 years site monitoring experience in global clinical projects, preferably in oncology or advanced therapies, with strong communication and multitasking skills. | PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Coordinates investigator/ site feasibility and identification process, as well as study startup. Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. Manages Monitors in the query resolution process, including Central Monitoring observations. Coordinates safety information flow and protocol/process deviation reporting. Performs clinical supplies management with vendors on a country and regional level. Ensures study-specific and corporate tracking systems are updated in a timely manner. Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. Coordinates planning of supervised monitoring visits and conducts the visits. Manages the project team in site contracting and payments. Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. Ensures ongoing evaluation of data integrity and compliance at a country/regional level. Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. Oversees project team in CAPA development and implementation. Coordinates project team in process deviations review, management and reporting. Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. Delivers trainings and presentations at Investigator Meetings. Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. Ensures data integrity and compliance at a site level. Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. Conducts project-specific training of site Investigators. Supports preparation of draft regulatory and ethics committee submission packages. Qualifications Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. Experience with all types of monitoring visits in Phase II and/or III. Strong experience in Oncology preferred. Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. Full working proficiency in English. Proficiency in MS Office applications. Ability to plan, multitask and work in a dynamic team environment. Excellent Communication, collaboration, and problem-solving skills. Ability to travel up to 50% (depending on project needs). Valid driver’s license (if applicable). Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Lead patient recruitment and retention strategies, manage site partnerships, develop patient engagement solutions, and collaborate across departments to improve enrollment metrics. | 10+ years clinical research experience, 5+ years site communication and patient recruitment experience, proficiency in MS Office, and ability to work autonomously. | PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description The Manager Site Relations, titled Manager Patient Recruitment & Retention Strategy, will be responsible for the operations, communication, and development of strategic site partnerships. • Develops global enrollment and retention solutions to increase patient screening, randomization, and compliance • Builds and manages patient engagement service offerings and associated costs for global bids, including vendor and in-house resource allocation • Designs and implements patient engagement assessments for awarded studies, focused on impact measurement, analysis, and mitigation planning • Participates in scientific conferences, meetings, symposia, etc. to collect information on patient access and diversity • Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies. • Liaises with other PSI departments to collate operational feedback and support patient engagement strategy • Liaises with Project Management to evaluate the impact of recruitment services on patient enrollment metrics for awarded studies • Collaborates with Business Development and Feasibility to identify and illustrate the value-add of prioritized recruitment services • Develops and facilitates training programs to department staff and across key functional areas based on area of expertise Qualifications EDUCATION • University/college degree, ideally in the life science or health care field • MD, PharmD, PhD, or RN qualification is a plus EXPERIENCE • A minimum of 10 years’ experience in clinical research • A minimum of 5 years’ experience in site communication, site relationship management, and patient recruitment; CRO experience preferred • Experience in scientific report writing, independent research, and data analysis SKILLS • Proficiency in standard MS Office applications • Must have critical thinking and problem-solving skills and have the ability to work autonomously • Proficiency in and the ability to learn/work with different databases and software tools Additional Information Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.