PSI CRO AG

Research Analyst

• Conduct and report all types of onsite monitoring visits as well as remote visits
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be involved in site identification process
• Assist in training of less expert CRAs, depending on your level of experience

Clinical Research Associate / Senior Clinical Research Associate

Content Writer

• Write short-form and long-form content on PSI's clinical trial services (blogs, white papers, case studies)
• Revise and edit content before publication
• Work with Digital Marketing Strategists to monitor content performance and engagement
• Conduct research on assigned topics and identify third-party sources to ensure PSI content is authoritative and accurate
• Work with the Marketing Strategist and Global Marketing Manager to build editorial calendars
• Conduct interviews with internal & external SME's to identify topics of interest and opportunities to showcase PSI expertise
• Collaborate with team members to ensure consistency in branding, style and messaging and alignment with the PSI Style Guide

Backend Engineer

• Architect, develop, and maintain business applications across multiple projects
• Process user requests for new features and provide support for existing IT systems
• Prepare documentation related to development and maintenance of applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track development, maintenance, and related tasks in the team’s tracking system
• Stay up to date with evolving system development technologies and continuously advance your professional skills

Full Stack .NET Developer

Full-stack Engineer

• Architect, develop and maintain business applications
• Process user requests for developing of new and support for existing IT systems
• Prepare documentation related to development and maintenance of business applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track the development, maintenance and related tasks in the tracking system used within the team
• Follow the progress of systems development technologies and advance professional skills as necessary

Full Stack Developer, AI Solutions

Business Development Rep

• Expand our existing client base in the United Kingdom
• Actively prospect and leverage potential new business opportunities within specified Customer/Accounts
• Cultivate strong, long-term relationships with key decision-makers and develop deep knowledge of the Customer/Account organization
• Analyze potential opportunities and develop detailed business plans and sales strategies for each Customer/Account
• Identify and respond to Customer/Account needs to define potential PSI opportunities
• Ensure appropriate strategy/solution is proposed to Customer/Account
• Lead entire sales process including identifying the appropriate team for pitch and preparing and leading sales presentation
• Coordinate with Proposal Development Group to develop proposal and finalize strategy and pricing
• Handle follow-up related to the sales and facilitate completion of contractual documents
• Ensure appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations
• Monitor customer satisfaction through regular formal and informal surveys
• Attend industry events, set up meetings at events, and perform follow-up with potential clients

Director, Business Development

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Be involved in site identification process
• Support regulatory team in preparing documents for study submissions
• Prepare for and participate in audits and inspections

Clinical Research Associate II

• Actively prospects and leverages potential new business opportunities within specified Customer/Accounts
• Cultivates strong, long-term relationships with key decision-makers with Account and develops deep knowledge of the Customer/Account organization
• Analyzes potential opportunities and develops detailed business plans and sales strategies for each Customer/Account
• Identifies and responds to Customer/Account needs in order to define potential PSI opportunities
• Ensures appropriate strategy/solution is proposed to Customer/Account
• Works with Operations to identify sales team and prepare presentation
• Educates team participants in Customer/Account culture, operational needs/methods and sales techniques needed to close the sale
• Leads the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation
• Coordinates with the Proposal Development Group to develop proposal and Operations to finalize strategy and pricing
• Handles follow-up related to the sales and facilitates completion of contractual documents
• Ensures appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations
• Shares Customer/Account strategies and sales plans with Project Directors/Managers
• Coordinates with Project Managers/Directors and Operations to escalate and quickly address Customer/Account issues/concerns
• Seeks input from Project Managers/Directors to proactively address Change in Scope, new opportunities or customer dissatisfaction
• Works with Project Manager/Director and Operations to ensure Changes in Scope (CIS’s) are appropriately negotiated with the Customer/Account
• Maintains high visibility within Customer/Account organization
• Monitors Customer satisfaction through regular formal and informal surveys
• Coordinates with Project Managers/Directors to ensure Customer/Account needs are being met and address concerns/issues in a timely manner
• Reviews proposals and analyzes requests for proposals and protocols
• Attends industry events, set up meetings at events, and perform follow-up with potential clients
• Acts as a liaison between US clients and Operations on an as needed basis

Data Scientist

• Responsible for all data management activities in large, complex studies under general supervision
• Primary communication point for project teams and company departments with regard to clinical data management
• Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, and reconciliation
• Primary responsibility for clinical data management activities within clinical projects
• Training of Assistant Data Managers and clinical team in CRF completion

Lead Data Manager

• Responsible for all data management activities in large, complex studies
• Primary communication point for project teams and company departments regarding clinical data management
• Coordination of data management activities related to EDC development, data collection, cleaning, reconciliation
• Ensure quality of data validation, data entry coordination, database lock

• The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies
• Provide general oversight on all Data Management activities on large complex global studies
• Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
• Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables
• Primary responsibility for clinical data management activities within clinical projects, including, but not limited to: Reviews and approvals, escalation point and troubleshooting
• Involved in audits and inspections
• Supporting with SOP development and process improvements
• Provide input into Proposals, Budgets and Bid Defense meetings
• Clinical database lock Coordination and supervision of processing, dispatch and archiving of CRFs/queries
• Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
• Development of CRF completion guidelines
• Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
• Electronic data transfer (import/export) specifications review and approval
• Quality Control Database QC checks performance and documentation
• Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
• Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
• Training junior members of the team
• Project-specific training of investigators and clinical team in CRF completion

Senior Data Manager

• Responsible for oversight of all data management activities in large, complex studies
• Provide general oversight on all Data Management activities on large complex global studies
• Coordinate data management activities within clinical projects related to EDC development
• Primary responsibility for clinical data management activities within clinical projects
• Involved in audits and inspections
• Coordination and supervision of processing, dispatch and archiving of CRFs/queries
• Development of CRF completion guidelines

Human Resources

• Serve as the first point of contact for HR-related inquiries from employees
• Support the full employee lifecycle including recruitment, onboarding, performance management, and offboarding.
• Administer employee benefits programs and benefit communications.
• Administer all employee leave programs, including FMLA, ADA, state-specific leaves, personal leaves, and other time-off requests.
• Maintain accurate and confidential employee records in HRIS and personnel files.
• Partner with managers to address employee relations issues, conduct investigations, and recommend appropriate actions.
• Assist in developing and implementing HR policies and procedures in compliance with federal, state, and local laws.
• Support payroll processing by providing accurate employee data and resolving discrepancies.

HR Generalist

Project Manager

• Management of small (<5 countries and/or limited services) and medium sized (5-15 countries and/or full service) projects under general supervision with primary responsibility for the production of project deliverables in conformance with the predefined quality standards, on time and on budget
• Performing the project co-manager’s role in complex international projects/programs with secondary responsibility for the production of project deliverables in conformance with the predefined quality standards, on time and on budget
• Adherence to and promotion of principles of delivery and service in dealing with PSI customers
• Project team leadership
• Training, mentoring and coaching of study team members
• Participation in feasibility research
• Assistance in business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like
• Implementation of company standard practices and compliance with intradepartmental procedures

Clinical Research Associate / Senior Clinical Research Associate

Content Writer

Content Writer

Content Writer

Full Stack .NET Developer

Full Stack Developer, AI Solutions

Director, Business Development

Clinical Research Associate II

Director, Business Development

Lead Data Manager

Lead Data Manager

Senior Data Manager

Senior Data Manager

HR Generalist

Lead Project Manager