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External

đź‘Ą 10-50Business IntelligenceAppsSoftwaređź’Ľ Private Company
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External is a dedicated team of clinicians, scientists, and researchers committed to enhancing healthcare through authentic, personalized attention. With a focus on adapting to the rapidly changing industry landscape, they cherish the diverse backgrounds and motivations of their members, which contribute to their unique approach.

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Jobs at this company:

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🔥 Senior Clinical Research Associate (Contractor) - India - Remote
Posted 1 day ago

đź“Ť India

🧭 Contract

🔍 Clinical Research

  • 5+ years of experience as a Clinical Research Associate
  • Demonstrable experience of handling multiple protocols across a range of therapeutic indications
  • Excellent interpersonal, oral, and written communication skills in English
  • Superior organizational skills with attention to details
  • Proficiency in Microsoft Office, CTMS and EDC Systems
  • Managing the research activities at sites participating in Worldwide’s clinical research projects, which are predominantly registries and other types of non-interventional / observational studies
  • Conduct study initiation visits (SIVs)

Microsoft OfficeComplianceEnglish communication

Posted 1 day ago
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🔥 In-house Clinical Research Associate II - U.S. - Remote
Posted 1 day ago

đź“Ť United States of America

🔍 Clinical Research

  • Bachelor’s Degree or a Nursing Degree required
  • Minimum of two years experience as an In-House CRA or Clinical Research Coordinator (CRC)
  • Proficiency in Microsoft Office, CTMS, and EDC Systems
  • Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
  • Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification etc.)
  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
  • Perform feasibility studies/site identification activities for potential sites, as requested

Communication SkillsMicrosoft OfficeWritten communicationFluency in EnglishEnglish communication

Posted 1 day ago
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🔥 Strategic Sourcing Analyst - U.S. - Remote
Posted 1 day ago

đź“Ť United States of America

🔍 Pharmaceutical /CRO

  • BA/BS degree in Business Administration or related field or equivalent combination of education and experience
  • Minimum 5 years in the Pharmaceutical /CRO industry required
  • Sourcing/Category management experience or similar role preferred
  • Strong project management and leadership skills
  • Knowledge and/or management of clinical services in clinical trials is a plus
  • Requires strong presentation, documentation, and interpersonal skills
  • Proficiency in MS Office is required
  • An analytical mind with strategic ability
  • Establish and maintain business relationships with selected third-party vendors that would support the Worldwide Clinical Trials organization globally
  • Analyze data and market research to determine trends
  • Develop and implement sourcing and category management strategies for assigned categories
  • Liaise with internal stakeholders for business needs
  • Support and build Preferred Provider relationships through strategic sourcing processes
  • Development of RF(x) for commodity-sourced (if applicable)
  • Attend capabilities presentations for a complete understanding of the services being sourced
  • Negotiate pricing, rebates, business terms and conditions, etc.
  • Ensure vendors are compliant with negotiated terms through periodic face-to-face meetings
  • Work with Vendor Management to promote the use of Preferred Providers throughout the organization
  • Tracking of Cost Savings opportunities is essential
  • Spend under management analysis
  • Develop ad hoc analysis and reports as required
  • Some Tactical Sourcing Required
  • Supports project teams with vendor negotiations and project efficiencies
  • Support cross-functional Vendor Management team members as needed
  • Participate in Strategy Meetings as needed
  • Work with the Director of Procurement to establish career progression plans, performance reviews, and employee relations
  • Perform other duties as assigned

Project ManagementData AnalysisProject CoordinationCommunication SkillsAnalytical SkillsMicrosoft ExcelNegotiationInterpersonal skillsMS OfficeStrategic thinkingFinancial analysis

Posted 1 day ago
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🔥 Patient and Site Engagement Lead - UK/EMEA- Romania/Croatia/Poland - Remote
Posted 1 day ago

đź“Ť United Kingdom, Croatia, Romania

🔍 Healthcare

  • 8+ years’ of transferrable experience in medical, healthcare, scientific or related field, with preference for experience in patient engagement, recruitment & retention, feasibility or site-study coordination research roles.
  • Knowledge of the principles of Good Clinical Practice.
  • Must have competent computer skills in MS Word, Excel, and PowerPoint
  • Support the Strategic Feasibility assessment during proposals phase, including providing Study Burden Analysis, and Patient and Site insights, so that patient-focused and site engagement study risks are incorporated.
  • Develop bespoke Patient and Site support strategies to meet customer needs and articulate the value proposition for implementing these strategies.
  • Present at bid defense or other client meetings as needed.
  • Develop and maintain collaborative relationships with internal stakeholders and establish a robust process with these key functions to ensure patient experience data and insight are systematically captured, collated and shared to inform strategy and planning.
  • Understand and evaluate Patient Pathway and trial burden for new study opportunities and communicate associated risks and support needs.
  • Work with cross-functional teams to build FDA Diversity Action Plans, UK Patient and Public Involvement (PPI) projects and other patient engagement-related projects to meet regulatory needs in your therapy area.

Project ManagementData AnalysisCross-functional Team LeadershipCommunication SkillsAnalytical SkillsCollaborationAgile methodologiesMentoringAttention to detailOrganizational skillsWritten communicationRelationship buildingProblem-solving skillsMS OfficeResearchReportingTrainingRecruitmentClient relationship managementRisk ManagementStakeholder managementStrategic thinkingPowerPoint

Posted 1 day ago
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🔥 Patient and Site Engagement Lead - UK/EMEA- Romania/Croatia/Poland - Remote
Posted 1 day ago

đź“Ť United Kingdom, Poland, Croatia

🔍 Medical, Healthcare, Scientific

  • Minimum Bachelor’s degree or equivalent.
  • 8+ years’ of transferrable experience in medical, healthcare, scientific or related field, with preference for experience in patient engagement, recruitment & retention, feasibility or site-study coordination research roles.
  • Knowledge of the principles of Good Clinical Practice.
  • Must have competent computer skills in MS Word, Excel, and PowerPoint
  • Support the Strategic Feasibility assessment during proposals phase, including providing Study Burden Analysis, and Patient and Site insights, so that patient-focused and site engagement study risks are incorporated.
  • Develop bespoke Patient and Site support strategies to meet customer needs and articulate the value proposition for implementing these strategies.
  • Present at bid defense or other client meetings as needed.
  • Develop and maintain collaborative relationships with internal stakeholders and establish a robust process with these key functions to ensure patient experience data and insight are systematically captured, collated and shared to inform strategy and planning.
  • Understand and evaluate Patient Pathway and trial burden for new study opportunities and communicate associated risks and support needs.
  • Work with cross-functional teams to build FDA Diversity Action Plans, UK Patient and Public Involvement (PPI) projects and other patient engagement-related projects to meet regulatory needs in your therapy area.

Project ManagementData AnalysisCommunication SkillsAnalytical SkillsMicrosoft ExcelAgile methodologiesOrganizational skillsExcellent communication skillsMS OfficeRecruitmentCross-functional collaborationRelationship managementRisk ManagementStakeholder managementComputer skillsPowerPoint

Posted 1 day ago
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🔥 Corporate Paralegal - East Coast - Remote
Posted 1 day ago

đź“Ť United States of America

🔍 Contract Research Organization

  • Working knowledge of general legal and contracting principles required
  • Strong communication skills, including written, verbal, and interpersonal skills
  • Ability to work independently and as part of a team with other legal advisors and business partners
  • Highly proficient in Microsoft Word, PowerPoint, and Excel
  • Ability to manage external counsel and internal stakeholders
  • Experience with a pharma/biotech/contract research organization a plus
  • A minimum 3+ years of recent corporate paralegal experience working in a law firm on global matters or in a global corporate legal team setting
  • Completion of an accredited paralegal program or equivalent combination of training and experience
  • A bachelor’s degree is strongly preferred
  • Candidates must reside in the Eastern Time Zone
  • Immediate availability
  • Creating and supporting the finalization of organizational documents, including powers of attorney, board resolutions, and articles of incorporation
  • Manage and update the database of global legal entity corporate documents
  • Respond to requests from third parties, including regulatory agencies, banking institutions, and auditors, including the preparation of response letters, and the collection of relevant corporate documentation
  • Working closely with in-house counsel, finance, administration, HR, global outside counsel, and other third-party vendors to create, gather, update, and provide corporate documentation as needed to support the business
  • Support in-house counsel in formatting and drafting templates, contracts, and agreements, such as confidentiality agreements, employment agreements, and related documents, notices to clients, vendors, and other third parties
  • Review and negotiate confidentiality agreements
  • Administer execution and delivery of contracts to internal stakeholders and outside parties, and file in the appropriate organizational filing structure as needed
  • Manage the legal department's online document filing structure
  • Manage filing, destruction, and retention of hard copy legal documents in accordance with the company’s data retention policy
  • Responding to requests for corporate information as needed to support bids and proposals
  • Assisting with ethics and compliance programs, and drafting and updating of corporate policies and SOPs
  • Liaise with outside counsel and internal business partners to answer questions, provide documentation, and facilitate the registration process for trademarks, assist with name clearances, reports on status, and manage renewals
  • Manage and update the global outside legal counsel database
  • Coordinate invoicing and payment administration for outside counsel and corporate filing expenses

Communication SkillsMicrosoft ExcelAttention to detailOrganizational skillsWritten communicationMS Office

Posted 1 day ago
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🔥 Project Manager (Contractor) - Oncology - Turkey - Remote
Posted 1 day ago

đź“Ť TĂĽrkiye

🧭 Contract

  • 5 years' industry experience with previous experience in a Clinical Project Management role, within a CRO setting.
  • Excellent interpersonal, oral, and written communication skills in English.
  • Proficiency in Microsoft Office, CTMS and EDC Systems.
  • Manage clinical trials from start-up through closeout activities.
  • Direct the technical, financial and operational aspects of the projects.
  • Ensure project deliverables meet customer expectations.

Project ManagementProject CoordinationFinancial ManagementCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelMicrosoft OfficeAgile methodologiesAttention to detailOrganizational skillsTime ManagementWritten communicationInterpersonal skillsExcellent communication skillsMS OfficeNegotiation skillsCross-functional collaborationRisk ManagementStakeholder managementComputer skillsEnglish communicationBudget management

Posted 1 day ago
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🔥 Senior Auditor, Audits and Inspections Program - US/Canada - Remote
Posted 1 day ago

đź“Ť United States, Canada

🔍 Software Development

  • Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities.
  • Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree.
  • Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP.
  • Excellent experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.).
  • Previous experience in trending and analysis methodologies.
  • M.S. in a scientific or allied health filed and 5+ years of relevant GCP, GcLP, GLP, GVP, and / or GPP experience.
  • Excellent understanding of the Drug Development Process.
  • Minimum 3 years of Quality Assurance auditing experience.
  • IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint.
  • Champions and adheres to Worldwide’s Quality Management System (QMS).
  • Serves as a positive ambassador of the QA organization with internal and external customers.
  • Develops and executes to personal and QA goals and objectives.
  • Hosts external audits and regulatory inspections.
  • Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes.
  • Oversees, monitors and reports on QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements.
  • Oversees the maintenance and archiving of records for each audit.
  • Participates in the driving continuous process improvements.
  • Participates in the development and review of AIP Quality Management Documents, as assigned.
  • Assists in developing training material and/or delivers training related to audits and inspections.
  • Serves as a Subject Matter Expert on QA Quality Management processes for audits.
  • Communicates relevant regulatory intelligence that has impact on the QMS to the QA team.

Data AnalysisGCPQA AutomationSharePointAgile methodologiesComplianceMS OfficeQuality AssurancePowerPoint

Posted 1 day ago
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🔥 Contractor Senior Clinical Research Associate - 1 FTE - Turkey - Remote
Posted 2 days ago

đź“Ť TĂĽrkiye

🧭 Contract

🔍 Clinical Research

  • At least two years of independent clinical monitoring experience
  • Demonstrable experience in handling multiple protocols across a range of therapeutic indications
  • Four-year college curriculum in life sciences, OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree)
  • Ability to meet the travel requirements of the job
  • Conduct all types of visits – site qualifications, initiation, interim monitoring, site management and study close-out visits
  • Review study subject safety information and informed consent and conduct source document verification for compliance, patient safety, and veracity of data
  • Actively participate in study team and investigator meetings
  • Compile and ensure completeness of regulatory documents and ethical submission documentation and review study subject safety information and informed consent and study material (e.g. CRFs, manuals)

Communication SkillsMicrosoft OfficeOrganizational skillsReportingData entry

Posted 2 days ago
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🔥 Site Contracts Lead - US/LATAM - Remote
Posted 6 days ago

đź“Ť United States, Argentina, Mexico

🔍 Clinical Research

  • Mastery in negotiating complex contract terms with clinical sites and vendors
  • Excellent verbal and written communication skills to interact with internal stakeholders, clinical sites, Sponsors, and regulatory authorities, if required.
  • In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
  • Ability to explain complex contract terms clearly and concisely
  • Leadership skills to guide and support junior contract specialists
  • Ability to collaborate effectively with cross-functional teams, including but not limited to legal, finance, data protection and clinical operations.
  • Bachelor's Degree or equivalent in business administration, finance, science or related field.
  • Excellent verbal and written English language skills.
  • Proficiency with MS Word, Excel and Outlook
  • Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements
  • High degree of organizational, analytical, and team management skills.
  • Adept knowledge of the biopharmaceutical/CRO industry and applicable local regulatory requirements.
  • Main point of contact for the Project Team and Sponsor, for all Study site contracting activities, during the life of contracting on the Study.
  • Serves as a Lead and Subject Matter Expert (SME) on Clinical Trial Agreement processes at the Study level and in accordance with the Contract and Budget Plan (CBP), outlining a strategy for the contract negotiation process and responsibilities.
  • Presents sites contract negotiation processes during Alignment / Launch meetings and provides update during internal and external team meetings until finalization of contracting activities.
  • Communicates and facilitates site contracting strategies, contract turnaround/execution timelines, and sites contract tracking requirements.
  • Accountable for Study level site contracting tracking tools completeness
  • Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with Global Project Lead and Sponsor.
  • Supports, supervises, and mentors allocated Site Contracts Specialists, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution.
  • Responsible for ensuring the timely delivery of Study site contracting updates to stakeholders
  • Recognizes potential problems/areas of concern and formulates contingency plans during the Clinical Trial Agreement development and escalates appropriately.
  • Develops and implements mitigation plan to ensure the Clinical Trial Agreement deliverables are met.
  • Works closely with the Global Project Lead, Site Activation Manager, Regulatory Affairs Manager and/or other departments/Leads to ensure delivery of fully executed agreements in support of timely Study site activation deliverables to meet departmental goals.
  • Maintains a working knowledge of, and ensures compliance with applicable ICHGCP Guidelines, local regulatory requirements, Worldwide SOPs and project specific procedures; maintains and assures quality of work generated.

LeadershipProject ManagementCommunication SkillsAnalytical SkillsMentoringNegotiationComplianceRisk ManagementTeam managementStakeholder management

Posted 6 days ago
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