Research Analyst

• Site administration and site monitoring responsibility for assigned clinical studies according to Dokumeds and Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines
• Conduct of country and site feasibility
• Site initiation, routine monitoring and close-out visits
• Preparation and submissions to Ethics Committees/Regulatory Authorities
• Assistance in site contract management

Freelance Clinical Research Associate, Germany

Systems Engineer

• Pricing Systems Management & Maintenance
• Maintain and enhance Excel-based pricing models to ensure system accuracy, usability, and functionality
• Provide ongoing support and troubleshooting for pricing tools and manage updates to reflect business and pricing changes
• Pricing Analysis & Technical Execution
• Analyze pricing requests and requirements
• Translate business input into system configurations and outputs
• Ensure pricing logic aligns with strategy and financial assumptions
• Support development of budgets and pricing scenarios
• Proposal & Contract Support
• Assist Proposals & Contracts team with bid grid mapping
• Align client pricing formats with internal systems
• Support pre-award and post-award pricing deliverables
• Contribute to pricing components of proposals
• Cross-Functional Collaboration
• Partner with global operational teams to define cost drivers
• Communicate pricing assumptions and outputs
• Support alignment across functions (finance, operations, proposals, etc.)
• Process Improvement & Operational Efficiency
• Identify inefficiencies in pricing workflows
• Recommend and implement process enhancements
• Reduce cycle times for pricing and budgeting activities
• Contribute to operational excellence initiatives
• Training, Documentation & Knowledge Sharing
• Deliver training to global users on pricing tools and processes
• Maintain documentation for systems, processes, and methodologies
• Support knowledge transfer and onboarding of new team members
• Track and report pricing metrics and tool usage
• Problem Solving, Compliance & Quality Assurance
• Ensure pricing aligns with corporate policies and market standards
• Resolve moderately complex pricing and system issues
• Apply analytical judgment to ensure accurate outputs
• Maintain quality, consistency, and compliance in all pricing deliverables

Pricing Systems Analyst

• Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV).
• Participate in the site selection process with oversight from the Clinical Team Lead role.
• Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved.
• Contribute to the development and review of protocols, study tools, and materials as well as documentation for clinical trials.
• Provide mentoring, training, and co-monitoring of junior clinical team members.
• Develop and maintain effective working relationships with clinical sites and within Rho as well as ensure communication of project goals and critical requirements.
• Attend and present at meetings and conferences, including Investigator Meetings.
• Participate in the RFP process, including business development meetings.
• Participate in the Clinical Operations community at Rho by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials.
• Perform both onsite & remote monitoring and study closure activities across multiple protocols.

Clinical Research Associate II, Respiratory

Clinical Research Associate II, Pain Management

• Collect, track and review investigational site records relating to subject screening and enrollment.
• Assist in the development of study plans and status reports.
• Collect, track, and review all site regulatory documents.
• Assist with development and review of Informed Consent Forms.
• Interact with sites, clients, vendors and internal study team members.
• Maintain the clinical trials management system (CTMS) and other project tracking tools.
• Track study supplies and coordinate shipments of supplies to sites as needed.
• Manage the study Trial Master File (TMF) and ensure periodic TMF audits.
• Coordinate work with CRAs monitoring on-site.
• Perform on site co-monitoring and remote monitoring activities.
• Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines.

In-House Clinical Research Associate

Data Scientist

• Join us in redefining what it means to work for a CRO.
• Work closely with the multidisciplinary project team across the life cycle of the project to ensure data management is thoughtfully planned and delivered in a consistent, timely, and high quality manner.
• Key contributor to project success through development and utilization of innovative tools to help automate manual tasks and identify data trends in a timely fashion.
• Constant collaboration with project peers, particularly biostatisticians, statistical programmers, and clinical operations personnel.
• Independently perform and oversee completion of data management tasks to ensure clinical database design supports project outcomes.
• Proactively clean clinical trial data and mitigate risks.
• Effectively communicate data-related decisions to sponsors and ensure data management activities follow all applicable standards and project-specific procedures.

Clinical Data Manager

Clinical Operations

• Lead complex projects, conceptualizing the execution strategy for each component project
• Prepare project management plans and other governance documents
• Recommend and implement operational strategies as well as risk management plans
• Manage assigned project resources, including ensuring that project tasks are correctly assigned to staff and vendors
• Manage project scope of work, including recognizing and negotiating changes in scope
• Make tactical recommendations to customers to improve projects and provide strategic and tactical guidance to team members
• Mentor and provide training and orientation for team members
• Manage team dynamics and provide frequent feedback to team members
• Collaborate with customers to provide win/win solutions
• Contribute to business development initiatives, including proposals, responses to RFIs, and bid defense presentations

Senior Clinical Project Manager – EU

Engineer

• Maintain our existing computer and network setups
• Administrate and support all existing software and hardware, including Apple devices, Okta, Kanji, Google Workspace, Slack, Jira
• Troubleshoot and effectively support and resolve user issues
• Diagnose and resolve of hardware, software, networking, and system issues when they arise
• Own and take action on the Joiner-Mover-Leaver Process – lifecycle view (onboarding, changes, offboarding)
• Monitor and maintain IT compliance, ensuring policies and controls are properly implemented and followed
• Security maintenance and assistance with performing security audits
• Document processes for users and administrators, including creating guides tailored to both technical and non-technical audiences
• Keep up-to-date on new technologies and security risks
• Assist with implementing system and process improvements

Junior Services Engineer

Software Engineer

• Design or write program specifications based on consultations with supervisor, systems analysts, other programmers, and end users.
• Convert designs and specifications into computer code.
• Analyze code to find causes of errors and revise programs.
• Write and maintain documentation of changes to computer code, programs, and specifications.
• Review user and technical documentation written by others to confirm consistency with program operations.
• Revise program for corrections, enhancements, or system environment changes.
• Coordinate with other programmers about program revisions.
• Modify and maintain software programs written by others.

Statistical Programmer II

• Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users
• Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design
• Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions
• Act as the CDISC subject matter expert
• Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs
• Write and maintain documentation of changes to computer code, programs, and specifications
• Review user and technical documentation written by others to confirm consistency with program operations
• Offer expertise relevant to statistical programming and CDASH data collection for study start up, execution, and close out: review protocols, draft CRFs; prepare and review validation plans, review vendor DTAs, etc
• Modify and maintain software programs written by others
• Provide mentorship and training to peers and more junior programmers in areas of expertise
• Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management
• Perform functional lead activities on assigned projects while maintaining scope and budget oversight
• May provide guidance and input to the budgets and business submissions of proposals

Freelance Senior Statistical Programmer

• Create and monitor study timelines and project plans
• Recommend and execute risk management plans
• Identify issues within a project and lead the resolution within the team
• Review and develop protocols, consent forms, manuals of procedures, and other study documents
• Oversee all operational aspects of a protocol with clinical sites including responding to site questions or directing them to the appropriate functional area team members
• Manage assigned project resources, including ensuring that project tasks are correctly assigned to staff and vendors; manage team dynamics and provide frequent feedback to team members; mentor and provide training and orientation for team members
• Ensure that study websites and tracking systems contain current and accurate information
• Ensure that studies adhere to federal regulations and funding agency oversight requirements

Clinical Project Manager

Compliance

• On behalf of Rho’s clients, support and advise the CMC and related regulatory components of integrated development programs, including the review of technical documents, participation in technical discussions, and collaborations with CDMOs and other vendors.
• Provide CMC regulatory-related leadership, guidance, and support to a team
• Mentor and advise Rho staff in CMC regulatory strategy and product development by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
• Proactively identify risks and critically analyze problems affecting the programs and develop contingency plans as needed
• Facilitate achievement of strategic goals for a program
• Monitor ongoing progress of key CMC deliverables against Global Integrated Product Development Plan goals
• Ensure effective, accurate and timely communication of key issues and progress to the team and senior management
• Participate in the planning, preparation, and conduct of regulatory authority meetings; lead CMC discussions with regulatory authorities
• Manage scope of work, budget, and timelines for external vendors, including consultants and external CMC writers
• Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; provide guidance and input to the budgets and business submissions of proposals

CMC Regulatory Strategist

• Perform all site monitoring visit activities
• Participate in the site selection process
• Provide feedback to assist sites with resolution of detected deficiencies
• Contribute to the development and review of protocols, study tools, and materials
• Provide mentoring, training, and co-monitoring of junior clinical team members
• Develop and maintain effective working relationships with clinical sites
• Attend and present at meetings and conferences
• Participate in the RFP process, including business development meetings
• Participate in internal initiatives and standard operating procedures
• Perform both onsite & remote monitoring and study closure activities

Clinical Research Associate II – Neurology, Parkinsons

• Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV)
• Participate in the site selection process with oversight from the Clinical Team Lead role
• Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved
• Contribute to the development and review of protocols, study tools, and materials as well as documentation for clinical trials
• Provide mentoring, training, and co-monitoring of junior clinical team members
• Develop and maintain effective working relationships with clinical sites and within Rho as well as ensure communication of project goals and critical requirements
• Attend and present at meetings and conferences, including Investigator Meetings
• Participate in the RFP process, including business development meetings
• Participate in the Clinical Operations community at Rho by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials
• Perform both onsite & remote monitoring and study closure activities across multiple protocols

Clinical Research Associate II – Major Depressive Disorder

Risk

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
• Facilitates and leads preliminary risk assessments and suggests appropriate anticipated study specific risks.
• Develops and maintains the Integrated Quality Risk Management Plan (IQRMP) in coordination with cross-functional team; updates IQRMP as needed
• Updates RBQM related procedural documents and templates, including the IQRMP template
• Provides review of RBQM strategy and process and implements updates as needed
• Provides training, mentoring, and oversight to new/junior QRMs
• Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.
• Suggests updates to RBQM related procedural documents, templates, and overall strategy
• Immediately communicates/escalates serious issues to the relevant project team member(s) suggesting and developing action plans.
• Documents observations noted during reviews, investigates trends, issues and risks for root cause.
• Initiates set-up and provides inputs needed for KRI and QTL visualizations, via either a technology platform or an alternate tool.
• Maintains expert knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages study- and portfolio-level activities to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals/targets.
• May attend Investigator Meetings and/or sponsor kick-off meetings.
• Participates in project staff meetings as applicable and attends clinical training sessions according to the project specific requirements.
• Provides support of sponsor audits.
• Supports business development activities through bid defense meeting attendance and proposal development.
• Performs QTL reviews and is responsible for tracking Quality Tolerance Limits reviews, results and mitigations.
• Utilizes KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in a clear and concise presentation of the most relevant and actionable items for interpretation by Project Leads, Sponsors and other functional roles assigned follow-up.