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Rho, Inc.

Remote Jobs

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

22 open rolesLatest: Jul 13, 2026, 4:03 PM UTCCompany Site
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22 Jobs

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Clinical Team Lead

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Role Description We are hiring a Clinical Team Lead! This is a permanent role to work remotely, with the expectation of occasional travel for site visits and client meetings. The Clinical Team Lead (CTL) is responsible for managing and maintaining ownership of the clinical operations aspects of assigned projects. This position is responsible for providing direction and training to CRAs assigned to the project. In addition, the CTL is responsible for the oversight of all operational aspects related to the planning and oversight of CRA and site performance. The CTL is responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations. - Manages the end-to-end clinical execution of projects up to moderate complexity and scope and/or supports a senior-level CTL on more complex or larger scope projects, ensuring adherence to protocols, timelines, and regulatory requirements. - Oversees recruitment, study metrics monitoring, and documentation activities. With guidance, identifies issues and contributes to implementing solutions. - Ensure sites comply with Good Clinical Practice (GCP) and applicable regulations. - Collaborates with cross-functional teams (e.g., data management, regulatory, safety) to facilitate study deliverables. - Develops and manages clinical operation timelines, metrics, resourcing, budget and activities of projects up to moderate complexity and scope. May also support senior CTLs on more complex or larger scope projects. - Identifies potential risks and escalates to appropriate stakeholders, supporting collaboration and leading implementation of appropriate corrective actions and mitigation strategies. - Manages tracking and reconciliation of clinical budgets related to clinical operation activities such as monitoring visit and CRA allocation. Identifies potential budget variances and escalates to appropriate stakeholders to ensure timely corrective actions are taken and cost-effectiveness is maintained. - May assist with RFP strategic planning, budget development, and capabilities/response narratives. - Performs monthly assessment of CRA resourcing projections based on study parameters (e.g., active sites, projected Days On Site, upcoming milestones, etc.). Works with CRA Line Management to proactively confirm resourcing needs. - Serves as the lead clinical liaison among Clients, site staff, and internal teams on projects up to moderate complexity. - Leads internal and external meetings. - Manages routine Client communications and helps manage client expectations. - Communicates and works effectively with site staff, as needed, serving as an escalation point for CRAs as issues arise. - Leads CRAs and IHCRAs, including project training and onboarding. - Creates and conducts training sessions including investigator meetings, conferences, and team training. - Provides constructive performance feedback on CRAs/IHCRAs to line managers and project leads. - May participate in Bid Defense Meetings to present clinical operation and monitoring strategy. - Participates in upfront Protocol Deviation planning and identification, in support of finalization and maintenance of Protocol Deviation Plan and related activities. - Manages protocol deviation review and reconciliation throughout the study, ensuring timely documentation and resolution in collaboration with cross-functional teams and Client for review and approval on projects of up to moderate complexity. - Supports the identification and continuous assessment of clinical risks throughout the study and contributes to the development and implementation of risk mitigations on projects of up to moderate complexity. - Provides skilled review and development of study protocols and study-related documents and materials (e.g., clinical monitoring plan, protocol deviation plan, case report forms). - Oversees and performs on-site Quality Compliance Visits to review data across CRAs using a targeted, adaptive and/or risk-based approach focused on critical and safety related data points. Identifies trends and potential quality issues, escalating as appropriate. Collaborates with CRAs and study teams to implement corrective and preventive actions. Qualifications - Bachelor's Degree, preferably in a life science, nursing, pharmacy or related field. - 5 years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry. - At least 2 years of experience working as a clinical team lead preferred. - At least 2 years of on-site monitoring experience. - Proven leadership capabilities with experience in leading teams within a CRO or pharmaceutical setting. - Strong knowledge of GCP and regulatory requirements, as well as familiarity with clinical trial processes and documentation. - Excellent interpersonal and communication skills, able to build relationships with clients and teams. - Demonstrated ability to manage multiple priorities and deliver on deadlines in a fast-paced environment. - A proactive, solutions-oriented mindset with the ability to drive decisions and lead initiatives. - Experience using clinical trial management software and EDC systems. Benefits - Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

Worldwide
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Advisor, Patient Recruitment Strategy

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Recruitment6 days ago

Role Description Rho is establishing a dedicated Patient Recruitment Strategy function to strengthen RFP responses, recruitment planning, vendor partnerships, and data-driven decision-making across clinical programs. This role will serve as a strategic recruitment expert, partnering with feasibility, site engagement, clinical operations, IT and business development teams to design scalable, fit-for-purpose recruitment strategies for Rho’s core therapeutic areas. The successful candidate will bring small-to-mid-size CRO or biopharma recruitment experience, excel at strategic planning and analytics, and act as both a trusted internal and external advisor on vendor selection, optimization, and performance oversight. Qualifications - Possesses an expert-level understanding of the biopharma-CRO proposal process - Thorough knowledge of the clinical research process, including site feasibility, site selection, country/region-level regulatory submissions, IRB submissions, site activation, and enrollment management - Working knowledge of regulatory, ethical, and privacy considerations impacting patient outreach and engagement activities - Demonstrated ability to conceptualize and architect end-to-end patient recruitment strategies that balance scientific and clinical validity, operational reality, patient experience, timelines, and cost - Demonstrated skill in translating protocol design and feasibility signals into forward-looking recruitment risk assessments and mitigation strategies - Proven ability to lead vendor selection and performance oversight for recruitment service providers - Demonstrated ability to influence senior stakeholders and drive alignment on strategic priorities - Comfort making defensible decisions in the presence of incomplete or imperfect data - Skilled in communicating data-driven insights in a manner appropriate for executive, sponsor, and operational audiences - Demonstrated ability to think critically, problem solve and apply sound judgment and reasoning - Demonstrated ability to handle multiple projects and administrative responsibilities - The ability to collaborate cross-functionally is essential - Comfort operating in a strategic- and consultatively-focused role - Communicates clearly and professionally in written and verbal formats - Strong leadership skills with demonstrated ability to navigate complex or challenging situations - Excellent presentation skills, both written and spoken - Strategic mindset towards leveraging technology, systems, and automation - Ability to assess when innovation is appropriate versus when proven approaches provide better reliability - Comfort operating in evolving environments - Proficient in Microsoft Office Suite - Bachelor’s degree in a clinical- or life science-adjacent field required; advanced degree preferred Requirements - Demonstrated experience establishing or governing recruitment strategy frameworks - Established track record of recruitment strategy development as a critical success driver - Experience collaborating with feasibility, study start-up, and/or clinical operations functions - Hands-on involvement in RFP support and proposal development relating to recruitment strategy - Demonstrated experience authoring and driving trial-, country-, and site-level recruitment plans - Experienced in leveraging an understanding of patient burden, access barriers, and equity considerations - Familiarity with digital recruitment channels and emerging patient engagement technologies - Strong experience managing, interpreting and leveraging patient recruitment data and metrics - Established track record of prospecting, prioritizing, and negotiating pricing structures with recruitment vendors - Having played an active role in the building and/or scaling of a new function or capability within a CRO or biopharma environment is preferred - Experience developing recruitment strategies for single virtual site/DCT trials is preferred - Therapeutic experience in Rho’s Core 4 therapeutic areas is preferred Benefits - Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance, and 401(k) - Paid time off, holidays, parental leave, and bereavement leave - Encouragement of work-life balance

United States
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Accounts Payable Specialist

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Accounts Payable20 days ago

Role Description We are currently hiring an Accounts Payable Specialist to join our team in Warsaw, Poland! The Accounts Payable Specialist supports the Finance team by processing supplier invoices and employee expenses in a multi-entity, multi-currency environment. This role is designed to align with global Accounts Payable standards while allowing for adaptation to local market requirements, regulatory frameworks, and operational practices. The position contributes to accurate, compliant, and timely payment processing across assigned regions/entities. Depending on business need, responsibilities may include support for entities in different regions. This position reports to the Accounts Payable Manager. Responsibilities include, but are not limited to, the following: - Process high volumes of supplier invoices across assigned entities and regions, in accordance with applicable local requirements and global AP processes. - Handle and process T&E (Travel & Expense) claims in line with company policies. - Ensure invoices are accurately coded and approved in line with company policies. - Verify invoice details, including applicable tax treatment, invoice compliance, and documentation requirements based on the relevant jurisdiction. - Manage supplier queries and resolve discrepancies promptly. - Maintain accurate and up-to-date vendor records. - Support payment runs, ensuring deadlines are met. - Reconcile supplier statements and investigate outstanding items. - Assist with month-end closing activities related to accounts payable. - Collaborate with internal stakeholders across different countries and departments. Qualifications - Bachelor’s degree required along with 1+ years of experience in Accounts Payable, finance administration, or a related area. - Proficiency in both English and local language. - Experience working with multiple entities, currencies, and varying market or regional requirements. - Exposure to regional or international AP processes is preferred, with the ability to learn jurisdiction-specific requirements as needed. - Understanding of accounts payable principles, invoice compliance requirements, and tax concepts relevant to the markets supported. - Experience using invoice processing or expense management tools (for example, Concur) would be an asset. - Familiarity with ERP systems such as SAP, Oracle, or NetSuite in a regional or global finance environment would be valuable. - Experience within a CRO, life sciences, shared services, or an international organization would be advantageous.

Poland
Rho, Inc. logo

Clinical Data Analyst

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Data Analyst28 days ago

Role Description Rho is looking for a Data Analyst to join us on a freelance basis in Poland. The Data Analyst is responsible for contributing to data analytics projects that support the organization's strategic goals and objectives. This role will use programming and data visualization tools to generate reports for clinical trial study teams and internal stakeholders, fostering informed decision-making and strategic insights. As a Data Analyst, you will have the flexibility to work remotely from Poland while being part of a collaborative and innovative environment. Responsibilities: - Leads the notebook tasks associated with project-specific reporting, working across the project team to ensure final reports meet the needs of all internal stakeholders. - Serves as technical support for Rave EDC build, including custom function programming. - Develops, validates, and makes updates as needed to a library of template notebooks to support reporting needs. - Programs data listings for Protocol Deviation review. - Capture, develop, and document data definitions, business rules, and data quality requirements. - Ensure compliance with deliverable reporting requirements by performing quality data audits and analysis. - Communicate and present data recommendations in a clear and compelling way. - Identify opportunities for data and process improvement, innovation, and optimization. - Participate in projects and tasks related to data integration, data cleaning, descriptive analyses, exploratory analyses, predictive modeling, data mining, text analytics, social media analytics, social network analysis, rapid prototyping, and data visualization to solve problems. - Implement new statistical or other mathematical methodologies as needed for specific models or analysis. Qualifications - Bachelor's degree in data analytics, statistics, mathematics, computer science, or related field. - 0-3 years of experience in data analytics, data science, or data engineering. Experience working in a contract research organization or a related industry is preferred. - Experience in Microsoft Fabric and NetSuite is required. - Demonstrated knowledge in data warehousing, ETL processes, and SQL programming. - Demonstrated knowledge in cloud platforms, particularly Microsoft Azure. - Demonstrated knowledge in data analytics and statistical modeling techniques, such as regression, classification, clustering, optimization, simulation, machine learning, and artificial intelligence. - Proficiency in scripting, data blending, data visualization, and statistical programming languages, such as Python, R, SQL, SAS, Spotfire, Tableau, Power BI, and Alteryx. - Demonstrated knowledge in designing, developing, and maintaining data systems and databases, using data warehousing, data integration, data quality, and data governance principles and tools. - Strong data communication and presentation skills, with the ability to translate data into actionable insights and recommendations for diverse audiences. - Strong analytical and problem-solving skills. - Strong collaboration and interpersonal skills, with the ability to work effectively with cross-functional teams and stakeholders at all levels of the organization. - High attention to detail and quality, with the ability to ensure data accuracy, validity, and reliability. - Self-motivated and proactive, with the ability to work independently and under pressure in a fast-paced and dynamic environment. Benefits - Opportunity to experience a thriving company with real stability - financial, workforce, and corporate. - Safe environment to innovate and develop over a long and rewarding career.

Poland
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Financial Systems Administrator

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Role Description Rho Inc is seeking a skilled Financial Systems Administrator to manage and optimize our suite of financial applications including NetSuite, Concur, and FloQast. The Oracle NetSuite & Financial Systems Administrator is a key member of the global finance function, responsible for: - Day-to-day management, optimization, and continuous improvement of core finance systems. - Ensuring that systems, data, and processes support accurate financial reporting, strong internal controls, and global compliance requirements. - Partnering closely with Finance, IT, and business stakeholders to deliver scalable, efficient, and compliant solutions across the organization. What you'll be doing: - Act as the primary administrator for NetSuite, Concur, FloQast and related financial systems. - Maintain user roles, profiles, permissions, and security settings. - Manage integrations and data uploads between NetSuite, Concur, ADP, Certinia/Salesforce and other data warehouse systems. - Monitor system performance, licensing and user capacity, troubleshoot issues, and coordinate with IT and vendors as needed. - Provide ongoing systems and technical support as the primary contact for all requests and issues with internal customers and to Oracle and other vendors. - Maintain a strong understanding of general ledger, AR, AP, revenue recognition, planning, audit scope and requirements, and reporting. - Develop and maintain workflows, validation rules, and automations to improve operational efficiency. - Partner with accounting, finance, FP&A and Transformation teams to translate business needs into system solutions. - Oversee data quality, ensuring audit readiness. - Build and maintain reports as needed. - Provide user support and training for finance systems functionality, working closely with Employee Experience staff. - Create and maintain documentation, process guides, and applicable procedure documentation and standard operating procedures. - Act as a liaison between business stakeholders and technical teams to ensure consistent adoption. - Stay current with all finance system updates and releases and recommend enhancements to functionality. - Participate in system governance, change control and continuous improvement initiatives. - Collaborate with internal stakeholders to plan and implement enhancements that support scalability and compliance. Qualifications - Bachelor’s degree in Accounting, Information Systems, Business Administration, Computer Science, Life Sciences Technology or related field. - 3–5+ years of NetSuite administrator experience with skills in configurations and custom integrations to other systems (i.e., Salesforce). - Experience working in a Contract Research Organization (CRO), professional services, or other project-based organization is preferred. - Oracle NetSuite certification is preferred. - Proficiency in report building, data management, and automation tools. - Experience with DCAA-compliant timekeeping systems and data integrity controls is a plus. - Exceptional analytical, problem-solving, and communication skills. - Ability to manage multiple priorities and stakeholders across global teams. - Detail-oriented with a commitment to accuracy, compliance, and continuous improvement. Benefits - Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). - Paid time off, holidays, parental leave, and bereavement leave. - Encouragement of work-life balance. Compensation The range of starting pay for this role is $90,000-$120,000 per year, influenced by role responsibilities, location, candidate skill set, and level of experience. Company Description Rho Inc is a dynamic Contract Research Organization (CRO) committed to innovation, collaboration, and excellence. We value curiosity, teamwork, and continuous improvement, offering a vibrant and rewarding work environment where your contributions will have a direct impact on the company's financial health and operational success.

United States
$90K - $120K / year
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Pricing Systems Analyst

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Systems Engineer40 days ago

Role Description We are currently hiring a Pricing Systems Analyst to join our team! As Pricing Systems Analyst (PSA), you will support pricing operations through the maintenance, enhancement, and optimization of pricing systems and tools. You will ensure accurate costing, support proposal development, and drive continuous improvement in pricing processes. You will apply your technical expertise and business understanding to deliver efficient, compliant, and high-quality pricing solutions. What you’ll be doing: - 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 Qualifications - Bachelor's degree, or equivalent, in appropriate scientific or business discipline - 3-5 years' experience in pharmaceutical industry/clinical research - Working knowledge of the clinical development process - 2 years of pricing/budgeting or negotiation and contract experience Requirements - Strong Communicator: Demonstrate written, verbal and presentation skills - Committed to Quality: Attention to detail and understanding of high-quality scientific standards - High-Character: Contribute to a collaborative culture with honesty and integrity - Critical Thinker: Evaluate situations and opportunities objectively and craft practical solutions - Agile and Adaptable: Ability to change quickly and embrace risk while managing it Benefits - Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance, and 401(k) - Paid time off, holidays, parental leave, and bereavement leave - Encouragement of work-life balance

United States
Rho, Inc. logo

Study Contract Manager

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Manager42 days ago

Role Description Rho Inc is seeking a Study Contract Manager, Europe to join our growing team dedicated to excellence in clinical research contract management. In this senior role, you will lead contract negotiations and management activities for clinical study agreements in the European Union, ensuring compliance with regional regulations and alignment with our company’s strategic goals. As a Study Contract Manager, you will collaborate closely with cross-functional teams including legal, business development, finance, and study operations to develop, negotiate, and finalize contracts that protect company interests and facilitate successful study execution. You will serve as a key point of contact for clients and vendors, demonstrating expertise in clinical research contracting across the European market. We offer a dynamic environment that promotes professional development and values your expertise in contract management within the clinical research industry. - Lead negotiation, drafting, and execution of clinical study contracts, budgets and related agreements within the EU region. - Collaborate with internal stakeholders such as legal, finance, business development, and study teams to ensure contract terms meet company objectives and compliance requirements. - Manage contract workflows to meet study timelines and client expectations. - Provide strategic guidance on contractual risks and opportunities related to regional compliance and regulatory environments. - Maintain strong relationships with clients and vendors, serving as a trusted advisor on contract matters. - Support process improvements and standardization initiatives within the contract management function. - Keep up to date with industry trends, regulations, and best practices in clinical study contracting in the EU. Qualifications - Bachelor’s degree in Business, Law, Life Sciences, or related field; advanced degree or certifications in contract management preferred. - Minimum of 5 years of experience in clinical research contract management, with strong focus on EU-based study agreements. - Budget negotiation experience is preferred. - In-depth knowledge of clinical trial regulations, local laws, and compliance requirements within the EU. - Proven ability to negotiate complex contracts and manage multiple stakeholders effectively. - Excellent communication and interpersonal skills, capable of interacting with diverse internal and external teams. - Strong organizational skills and attention to detail, with ability to manage competing priorities in a fast-paced environment. - Proficiency with contract management systems and Microsoft Office suite. - Fluency in English required; additional European languages considered a strong asset. Benefits - Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

Europe
Job Closed
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Clinical Research Associate II / Sr. CRA

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Research Analyst42 days ago

Role Description Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. We are currently hiring a Clinical Research Associate II or Senior Clinical Research Associate in experience in monitoring pain studies to join our team! As our next CRA II or Senior CRA, you will play an integral role in driving project success. You’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures. For this role, you’ll need proven monitoring skills in order to conduct site visits to assess site adherence to protocol and regulatory requirements as well as manage required documentation. You will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor, or a regulatory agency. This position is a remote role to be located within a 1-hour commute of a US metropolitan airport with the commitment to conduct 8-10 site visits days per month (up to 80% travel). What you'll be doing: - 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 Qualifications - BA/BS, preferably in a life science, nursing, pharmacy or related field - Approximately 2 years (CRA II) or 4-5 years+ (Senior CRA) of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry - Demonstrated understanding of medical/therapeutic area knowledge and medical terminology required for comprehension and execution of clinical protocol - Computer literacy, including proficiency in MS Office and use of EDC systems - Strong Communicator: Demonstrate written, verbal and presentation skills - Committed to Quality: Attention to detail and understanding of high-quality scientific standards - High-Character: Contribute to a collaborative culture with honesty and integrity - Critical Thinker: Ability to evaluate situations and craft novel, practical solutions - Agile and Adaptable: Ability to change quickly and manage risk Benefits - Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k) - Paid time off, holidays, parental leave and bereavement leave - Encouragement of work-life balance Compensation The range of starting pay for this role is $90,000 to $140,000 per year.

United States
$90K - $140K / year
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Validation Specialist II / III

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Role Description The Validation Specialist II / III will perform business analysis, validation, and testing processes required to support the software development and implementation process in the regulated clinical research field. The Validation Specialist II also directs the validation testing of ensuring final outcomes meet specified requirements. Lastly, this position ensures and facilitates corporate compliance with applicable regulations as they affect software development, implementation, and maintenance in a regulated environment including participation in audits as they pertain to software projects and systems. - Work closely with business primes to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process. - Identify and schedule project deliverables, milestones, and tasks required to validate software releases. - Research, develop, and write content for the validation of software products and services. - Prepare and maintain documentation and publications relating to users, systems, programming, operations, products, services, testing, and validation. - Create graphical images, flow charts, and diagrams for inclusion in documentation. - Lead and/or participate in developing SOPs (Standard Operating Procedures) that are followed to ensure regulatory compliance in developing or implementing software. - Ensure adherence to SOPs, regulatory validation, and quality assurance plans by software developers and their customers. - Act as an independent quality reviewer for peer software validations as well as openly accept critical quality reviews of one’s own work with the goal of producing high-quality documentation to support audits. - Ensure that developed application documents meet all project and SOP requirements. - Ensure compliance with testing environment requirements for validation testers. - Create and/or execute acceptance tests for software under development and/or commercial off-the-shelf software products. - Coordinate the recruitment, training, and testing of qualified testers to perform acceptance testing for new software releases. Qualifications - Bachelor's degree or international equivalent required with a minimum of 3 - 5 years of professional work experience within the clinical research industry; or an equivalent combination of relevant and preferred education and/or work experience. - Validation experience in GxP environment is required. - Demonstrates strong proficiency in validation methodologies, risk‑based validation, and regulatory expectations with minimal supervision. - Working knowledge of 21 CFR Part 11 regulations and a project management background is helpful. - Proficient in Microsoft Word, Microsoft Visio, Microsoft PowerPoint, Microsoft Project, Microsoft SharePoint, Microsoft Excel, and Adobe Acrobat. Requirements - Must have the ability to work as part of a cross-disciplinary team and to communicate and relate to a diverse number of co-workers. - Strong Communicator: Demonstrate written, verbal, and presentation skills to help showcase the successes of your work and Rho’s. Fluency in both English and local languages. - Committed to Quality: Attention to detail, a deep understanding of high-quality scientific standards, and an ability to care about every outcome. - High-Character: Contribute to a collaborative culture with honesty and integrity, valuing loyalty, accountability, and mutual trust. - Critical Thinker: Evaluate situations and opportunities objectively and craft novel, practical solutions. - Agile and Adaptable: Anticipate, respond to, and take advantage of changes in the environment while managing risks. Company Description

Poland
Job Closed
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Clinical Data Manager

Rho, Inc.

Established in 1984, Rho is a full-service contract research - CRO organization that has developed an excellent reputation for providing an "unsurpassed degree

Data Scientist56 days ago

Role Description Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. As our next Clinical Data Manager, you will have the opportunity to 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. You will be a key contributor to project success through: - Development and utilization of innovative tools to help automate manual tasks - Identifying data trends in a timely fashion - Constant collaboration with project peers, particularly biostatisticians, statistical programmers, and clinical operations personnel You will also 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. What you'll be doing: - Study Design & Standards - Independently designs CRFs and standard documentation - Reviews protocols and identifies basic study plan issues - Study Build & Start-Up - Assists with data import setup and standard report development - Supports EDC design/testing, creates edit checks, and performs UAT - Drafts templates and guidelines with minimal supervision - Data Review, Cleaning & Reconciliation - Leads data review planning and execution - Manages query workflows and SAE reconciliation - Identifies trends and prepares review meeting materials - Data Acquisition & Integrations - Supports integration setup/testing and manages lab ranges - Handles standard vendor data and flags discrepancies - Reporting, Lock & Closeout - Executes lock checklist and data verification - Reviews PDF packages and supports TMF readiness - Quality, Risk & Compliance - Improves processes, updates documents, and supports audits - Applies RBQM and QbD principles - Project & Stakeholder Management - Manages tasks across multiple projects and timelines - Prepares reports, tracks KPIs, and coordinates cross-functional teams - Handles vendor interactions and supports change initiatives - Leadership & Growth - Onboards and mentors new team members - Provides informal leadership and peer support - General Expectations - Attends in-person meetings as required - Demonstrates Rho’s Core Values and delivers excellent customer service - Communicates professionally and promptly - Maintains confidentiality and takes initiative - Performs other duties as assigned Qualifications - BA/BS degree along with at least 2-5 years of clinical data management experience - Experience working in clinical trials databases in a commercially available EDC system (e.g. Rave, Medrio, RedCap, Veeva); Medidata Rave build certification a plus - Working knowledge of an electronic data capture (EDC) system and CRF design principles - Demonstrated knowledge of data review and reconciliation process - Demonstrates effective analytical and problem-solving skills - Able to independently utilize available resources, including following Standard Operations Procedures (SOPs) and templates - Able to communicate clearly and effectively both written and verbal - Strong interpersonal skills and ability to work effectively and collaboratively within a team environment - Self-starter, able to work independently and have the ability to coordinate multiple activities simultaneously in support of various projects - Demonstrates attention to detail and commitment to producing high quality work - Proficiency in MS Word, Excel, PowerPoint Benefits - Comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k) - Paid time off, holidays, parental leave, and bereavement leave - Encouragement of work-life balance Company Description As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $70,000 to $110,000 per year. EOE. Veterans/Disabled

United States
$70K - $110K / year
Job Closed

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