The Senior Risk Manager plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles. More specifically, the Senior Risk Manager must: Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs. Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications. Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT). Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews. Advise on developing functional plans to mitigate risks effectively. Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity. Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations. Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies. Mentor peers and train new team members on functional delivery, risk evaluation, and action implementation. Escalate risks or deliverables at risk to the PM, including scope changes. Provide strategic input on risk characterization and reporting to leadership. Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks. Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Requirements: Qualifications Bachelor’s degree in a field relevant to clinical research; master’s degree or health data sciences degree preferred. Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements. Proficiency in Risk-Based Monitoring strategies, processes, and tools. Technical Skills Mastery of MS Excel (sorting, filtering, pivot tables). Advanced skills in analytical data visualization tools. Knowledge of Lean Six Sigma and web based RACT tools. Core Competencies Strong analytical and statistical understanding. Excellent communication, negotiation, and leadership skills. Ability to anticipate critical issues and develop proactive contingency plans. Skilled in project workflows and cross-functional collaboration. Training, mentoring, and organizational capabilities. Experience Minimum of 5 years in risk management within a clinical research setting. Minimum 7 years of experience across clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management. Attributes: Fluent in English (excellent oral and written). Must be able to communicate clearly and effectively at all levels within the organization and with external customers. Must be a fast learner and able to understand new concepts quickly. Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands. Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring. Broad working knowledge of the roles, functions and process of conducting clinical trials. Must be able to manage time effectively, working with multiple functions and requirements. Must have been involved in the use of trial management or data management systems. Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India. Show more Show less
The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs. The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero's standard operating procedures (SOPs) and processes. More specifically, the Senior Statistical Programmer must: Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time. Act as a Lead Statistical Programmer on multiple single studies. Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope. Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells. Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician. Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Indero and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT). Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Indero and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Indero and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable). Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs. Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs. Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables. Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes. Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements. May also: Mentor more junior Statistical Programmers. Requirements: Education Bachelor’ degree in Statistics, Computing Sciences or a related field; Master’s degree an asset Experience At least 7 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer. Knowledge And Skills Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. Excellent working knowledge of SAS; SAS certification an asset. Knowledge of XML programming an asset. Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. Very organized and detail-oriented, with effective project planning and time management skills. Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English; Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India. Show more Show less
The Central Monitoring Manager is responsible for the strategic and operational oversight of centralized monitoring activities across studies, from study start-up through database lock. This includes leading the development and implementation of study-specific centralized monitoring plans, supervising central monitor teams, and driving proactive risk identification and mitigation efforts. The role ensures centralized data reviews are completed with high quality and in alignment with timelines and contributes to cross-functional risk management and continuous process improvement. More specifically, the Central Monitoring Manager must: Oversee the development and execution of centralized monitoring plans across studies, ensuring consistency with RBQM strategy. Lead and manage a team of Central Monitors, providing guidance, oversight, and performance management. Ensure centralized monitoring reviews are completed to quality standards, on time, and within budget. Review and interpret data quality trends and operational signals to identify emerging risks at the study, country, and site levels. Contribute to risk assessments, periodic data reviews, and risk mitigation strategies in collaboration with cross-functional teams. Represent the Central Monitoring function in cross-functional meetings, audits, and client-facing discussions. Provide input into process improvement initiatives, tool development, and refinement of centralized monitoring methodologies. Ensure documentation of reviews and decision-making aligns with SOPs and regulatory expectations. Support training and development of Central Monitoring staff, ensuring alignment with protocol and project strategy. Coordinate resource planning and allocation for centralized monitoring activities across assigned studies. Maintain oversight of centralized monitoring data systems, reporting outputs, and departmental databases. Employees may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Requirements: Experience: Bachelor’s degree in a field relevant to clinical research. Minimum of 5 years of experience in centralized monitoring, with 12+ years in clinical research across functions such as clinical monitoring, data management, biometrics, or project management. Experience in line management a plus. Strong understanding of statistical monitoring principles, RBQM frameworks, and regulatory expectations related to clinical trial oversight. Hands-on experience with clinical trial database systems (e.g., EDC, IRT, CTMS) and data analytics tools. Demonstrated ability to analyze clinical data, identify meaningful trends, and drive data-driven decisions. Experience supervising and mentoring staff, with proven leadership in cross-functional environments. Ability to manage multiple projects and priorities in a dynamic environment. Attributes : Fluent in English (excellent oral and written communication skills). Strong analytical and problem-solving abilities. Effective communicator with the ability to engage internal teams and external clients. Highly organized, with the ability to manage workload, timelines, and shifting priorities. Knowledge of GCP, ICH guidelines, and applicable global regulations (e.g., FDA, Health Canada). Collaborative mindset with a commitment to continuous improvement and quality. Skilled in the use of Microsoft Office (Word, Excel, PowerPoint) and other business applications Our company: Our Company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. As a Clinical Systems Specialist, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Home-based position Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India. Show more Show less
The Senior Risk Manager plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles. More specifically, the Senior Risk Manager must: Provide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs. Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications. Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT). Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews. Advise on developing functional plans to mitigate risks effectively. Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity. Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations. Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies. Mentor peers and train new team members on functional delivery, risk evaluation, and action implementation. Escalate risks or deliverables at risk to the PM, including scope changes. Provide strategic input on risk characterization and reporting to leadership. Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks. Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Requirements Qualifications Bachelor’s degree in a field relevant to clinical research; master’s degree or health data sciences degree preferred. Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements. Proficiency in Risk-Based Monitoring strategies, processes, and tools. Technical Skills Mastery of MS Excel (sorting, filtering, pivot tables). Advanced skills in analytical data visualization tools. Knowledge of Lean Six Sigma and web based RACT tools. Core Competencies Strong analytical and statistical understanding. Excellent communication, negotiation, and leadership skills. Ability to anticipate critical issues and develop proactive contingency plans. Skilled in project workflows and cross-functional collaboration. Training, mentoring, and organizational capabilities. Experience Minimum of 5 years in risk management within a clinical research setting. Minimum 7 years of experience across clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management. Attributes: Fluent in English (excellent oral and written). Must be able to communicate clearly and effectively at all levels within the organization and with external customers. Must be a fast learner and able to understand new concepts quickly. Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands. Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring. Broad working knowledge of the roles, functions and process of conducting clinical trials. Must be able to manage time effectively, working with multiple functions and requirements. Must have been involved in the use of trial management or data management systems. Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Show more Show less
The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’s commitment to sponsor’s requirements and timelines. More specifically, the Clinical Data Coder must: Perform accurate coding of medical terms and medications utilizing industry-wide standards (MedDRA, WHO Drug) as well as company standards; Coordinate the assignment of appropriate dictionaries for meeting study requirements; Develop and maintain coding guidelines; Review and provide input to the Coding section of the Data Management Plan; Perform the Dictionary up-versioning activities and Synonym List upgrade; Validate/test the coding set up and programming of coding reports; may also test databases, edit specifications or any related programming activities; Conduct data review. Write and resolve data clarifications. Understand and comply with core operating procedures and work instructions. Perform other duties as directed by the Lead Data Manager. Meet objectives as assigned. Develop and maintain good communications and working relationships with the DM team. Requirements: Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience; Thorough knowledge of Medical Terminology; Thorough knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.); Experience working with clinical trials or within the pharmaceutical environment is preferred; Demonstrate understanding and experience in query management process; Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines; Excellent written and verbal English communication skills; Ability to work in a global team environment; Excellent organizational and analytical skills and high attention to detail; Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India.
The Regulatory Documents Assistant will establish and maintain the Sponsor electronic or paper Trial Master File (TMF) throughout the life of the trial and will perform record review of essential documents for accuracy and quality according to ICH-GCP. The Regulatory Documents Assistant is also responsible for the set-up of the Investigator’s Study File (ISF) binders. responsabilities Participates in the development of the TMF structure. Participates in the development of the electronic TMF (eTMF) Management Plan. Files or imports documents in the TMF. Performs record review of essential documents for accuracy and quality in the TMF. Assigns metadata and maintains trackers for the TMF. Sets up the conduct of eTMF quality reviews, performs, and addresses quality reviewfindings. Collaborates with the Project Assistant to define project scope and to develop the list ofexpected documents in the TMF. Works with the study team to resolve issues with the TMF. Receives and reviews regulatory documents from investigative sites for accuracy andcompliance with company SOPs and regulations. May assist project managers and coordinators with the creation and maintenance oftracking tools and study material. May assist with preparing shipments of study supplies to clinical sites. May serve as in-house contact to support Clinical Research Associates (CRAs). Participates in various administrative tasks as required to accomplish the goals of theprojects and the needs of the project teams Requirements: College degree; Knowledge of clinical trial operations; Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry; English (intermediate); French (Asset). Computer skills including proficiency in the use of Microsoft Word and Excel; Ability to organize own work and prioritize different assignments; Attention to detail and accuracy in work; Respect established timelines, expectations, priorities, and objectives; Versatile and comfortable in a multitasking environment Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India.
The Clinical Data Coder is primarily responsible for providing support to activities related to coding of Clinical data for ongoing clinical studies. The Clinical Data Coder will also participate in various clinical data management activities required to ensure that data captured are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’s commitment to sponsor’s requirements and timelines. More specifically, the Clinical Data Coder must: Perform accurate coding of medical terms and medications utilizing industry-wide standards (MedDRA, WHO Drug) as well as company standards; Coordinate the assignment of appropriate dictionaries for meeting study requirements; Develop and maintain coding guidelines; Review and provide input to the Coding section of the Data Management Plan; Perform the Dictionary up-versioning activities and Synonym List upgrade; Validate/test the coding set up and programming of coding reports; may also test databases, edit specifications or any related programming activities; Conduct data review. Write and resolve data clarifications. Understand and comply with core operating procedures and work instructions. Perform other duties as directed by the Lead Data Manager. Meet objectives as assigned. Develop and maintain good communications and working relationships with the DM team. Requirements: Bachelor’s degree or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience; Thorough knowledge of Medical Terminology; Thorough knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD etc.); Experience working with clinical trials or within the pharmaceutical environment is preferred; Demonstrate understanding and experience in query management process; Ability to work flexibly on simultaneous projects and proactively manage time to meet own deadlines; Excellent written and verbal English communication skills; Ability to work in a global team environment; Excellent organizational and analytical skills and high attention to detail; Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India.
The Regulatory Documents Assistant will establish and maintain the Sponsor electronic or paper Trial Master File (TMF) throughout the life of the trial and will perform record review of essential documents for accuracy and quality according to ICH-GCP. The Regulatory Documents Assistant is also responsible for the set-up of the Investigator’s Study File (ISF) binders. responsabilities Participates in the development of the TMF structure. Participates in the development of the electronic TMF (eTMF) Management Plan. Files or imports documents in the TMF. Performs record review of essential documents for accuracy and quality in the TMF. Assigns metadata and maintains trackers for the TMF. Sets up the conduct of eTMF quality reviews, performs, and addresses quality reviewfindings. Collaborates with the Project Assistant to define project scope and to develop the list ofexpected documents in the TMF. Works with the study team to resolve issues with the TMF. Receives and reviews regulatory documents from investigative sites for accuracy andcompliance with company SOPs and regulations. May assist project managers and coordinators with the creation and maintenance oftracking tools and study material. May assist with preparing shipments of study supplies to clinical sites. May serve as in-house contact to support Clinical Research Associates (CRAs). Participates in various administrative tasks as required to accomplish the goals of theprojects and the needs of the project teams Requirements: College degree; Knowledge of clinical trial operations; Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry; English (intermediate); French (Asset). Computer skills including proficiency in the use of Microsoft Word and Excel; Ability to organize own work and prioritize different assignments; Attention to detail and accuracy in work; Respect established timelines, expectations, priorities, and objectives; Versatile and comfortable in a multitasking environment Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India.
The Senior Clinical Data Coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. In addition to performing accurate coding tasks, the Senior Coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. This role includes leadership responsibilities and active participation in the design, oversight, and continuous improvement of coding processes. The Senior Clinical Data Coder will conduct all activities in alignment with applicable regulatory requirements, industry guidelines, and Indero SOPs, while ensuring sponsor timelines and expectations are consistently met. Key Responsibilities Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions. Oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows. Define, document, and manage coding conventions and ensure consistent application across studies. Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously. Manage coding priorities, balancing workload across timelines and studies. Develop and maintain coding guidelines and synonym lists. Provide input to the Coding section of Data Management Plans. Oversee and perform dictionary up-versioning and related upgrade activities. Validate and test coding setups, programming of coding reports, and related database checks. Support data review activities and resolve data clarifications in a timely manner. Provide mentorship and guidance to junior or back-up coders. Actively contribute to process optimization, SOP development, and best practices in coding. Maintain effective communication with Data Management Leads, CRAs, and other stakeholders. Requirements: Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background also acceptable). Minimum of 5 years’ relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment. Thorough knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug). Demonstrated experience with coding module setup, management of conventions, and prioritization of tasks across multiple studies. Experience in query management and clinical data review. Proven ability to manage multiple studies concurrently. Excellent written and verbal English communication skills. Strong organizational and analytical skills with high attention to detail. Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met. Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India.
Job Description The Senior Clinical Data Coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. In addition to performing accurate coding tasks, the Senior Coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. This role includes leadership responsibilities and active participation in the design, oversight, and continuous improvement of coding processes. The Senior Clinical Data Coder will conduct all activities in alignment with applicable regulatory requirements, industry guidelines, and Innovaderm SOPs, while ensuring sponsor timelines and expectations are consistently met. Key Responsibilities Lead and perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and internal conventions. Oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows. Define, document, and manage coding conventions and ensure consistent application across studies. Act as the Lead Coder, coordinating coding activities across multiple studies simultaneously. Manage coding priorities, balancing workload across timelines and studies. Develop and maintain coding guidelines and synonym lists. Provide input to the Coding section of Data Management Plans. Oversee and perform dictionary up-versioning and related upgrade activities. Validate and test coding setups, programming of coding reports, and related database checks. Support data review activities and resolve data clarifications in a timely manner. Provide mentorship and guidance to junior or back-up coders. Actively contribute to process optimization, SOP development, and best practices in coding. Maintain effective communication with Data Management Leads, CRAs, and other stakeholders. Requirements Bachelor’s degree or equivalent in pharmacy, life sciences, or a related field (medical/nursing background also acceptable). Minimum of 5 years’ relevant experience in clinical data coding within clinical trials or the pharmaceutical/CRO environment. Thorough knowledge of medical terminology and medical dictionaries (MedDRA, WHO Drug). Demonstrated experience with coding module setup, management of conventions, and prioritization of tasks across multiple studies. Experience in query management and clinical data review. Proven ability to manage multiple studies concurrently. Excellent written and verbal English communication skills. Strong organizational and analytical skills with high attention to detail. Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met. Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines. Our Company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India. Job Details Role Level: Not Applicable Work Type: Contract Country: India City: Pune ,Maharashtra Company Website: www.inderocro.com Job Function: Healthcare & Medical Services Company Industry/ Sector: Research Services What We Offer About The Company Searching, interviewing and hiring are all part of the professional life. The TALENTMATE Portal idea is to fill and help professionals doing one of them by bringing together the requisites under One Roof. Whether you're hunting for your Next Job Opportunity or Looking for Potential Employers, we're here to lend you a Helping Hand. Report Similar Jobs Veterinary Pathologist Talentmate Testing Analyst Adobe PlatformX Talentmate Marketing And Events Executive Talentmate Service Desk Manager Talentmate Senior Research Associate Talentmate Software Quality Assurance Engineer Talentmate Disclaimer: talentmate.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information. We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at abuse@talentmate.com.
Centralized monitoring is an integral part of a risk-based monitoring strategy, defined as the timely, remote review of accumulating subject and operational data to help distinguish between reliable and unreliable data, trends, outliers, and unusual variability using analytics and statistical methods. The Senior Central Monitor is responsible for setting up study-specific tools/analysis and a centralized monitoring plan for conducting a centralized statistical review of study data from study start through to study database lock, using analytical tools to identify emerging and existing risks to critical study data and process. The Senior Central Monitor enables proactive identification, communication, escalation, and management of risks at the study/country/site level. Responsibilities More specifically, the Senior Central Monitor must: Lead setup of study-specific tools/analysis and centralized monitoring plan for data review with support from the manager. Demonstrate expertise across the majority of analyses and identifies complex data quality trends per guidelines in alignment with the centralized monitoring plan. Provide training support to new and junior staff members within areas of expertise. Track and review timelines, develop analysis assignments for team and be able to organize, communicate with internal team, and delegate as appropriate to ensure reviews are completed on time, on budget, and with high quality. Develop and deliver centralized monitoring reports as well as lead centralized monitoring meetings with support from the manager, as needed. Represent centralized monitoring team in the cross-functional project specific risk assessment meetings (initial and periodic) with support from the manager. Support review set-up as directed by assigned including updating department database, pulling reports, etc. as assigned. Employees may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training. Requirements: Education Bachelor’s degree in a field relevant to clinical research. Experience: Minimum of 3 years of experience in central statistical monitoring with overall 8 years of experience in two or more operational areas such as clinical monitoring, data management, drug safety, medical monitoring, biometrics, or project management. Good understanding of statistical monitoring and Risk Based Quality Management (RBQM) and their impact on data integrity. Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations. Knowledge of clinical trial database systems (EDC, IRT, CTMS etc.). Good computer skills, with advanced knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems and tools. Ideally a good level of understanding of descriptive analysis e.g. means, medians, significance, confidence intervals. Must have been involved in the analysis and review of clinical data, ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems with the ability to learn to identify trending of site/study data. Must be able to work in non-traditional work environments. Attributes: Fluent in English (excellent oral and written). Must be able to communicate clearly and effectively at all levels within the organization and with external customers. Must be a fast learner and able to understand new concepts quickly. Prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands. Satisfactory understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring. Broad working knowledge of the roles, functions and process of conducting clinical trials. Must be able to manage time effectively, working with multiple functions and requirements. Must have been involved in the use of trial management or data management systems Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Our company: Our Company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. As a Senior Central Monitor, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Regulatory Documents Assistant will establish and maintain the Sponsor electronic or paper Trial Master File (TMF) throughout the life of the trial and will perform record review of essential documents for accuracy and quality according to ICH-GCP. The Regulatory Documents Assistant is also responsible for the set-up of the Investigator’s Study File (ISF) binders. responsabilities Participates in the development of the TMF structure. Participates in the development of the electronic TMF (eTMF) Management Plan. Files or imports documents in the TMF. Performs record review of essential documents for accuracy and quality in the TMF. Assigns metadata and maintains trackers for the TMF. Sets up the conduct of eTMF quality reviews, performs, and addresses quality reviewfindings. Collaborates with the Project Assistant to define project scope and to develop the list ofexpected documents in the TMF. Works with the study team to resolve issues with the TMF. Receives and reviews regulatory documents from investigative sites for accuracy andcompliance with company SOPs and regulations. May assist project managers and coordinators with the creation and maintenance oftracking tools and study material. May assist with preparing shipments of study supplies to clinical sites. May serve as in-house contact to support Clinical Research Associates (CRAs). Participates in various administrative tasks as required to accomplish the goals of theprojects and the needs of the project teams Requirements: College degree; Knowledge of clinical trial operations; Experience in clinical research in the biotechnology, pharmaceutical, and/or CRO industry; English (intermediate); French (Asset). Computer skills including proficiency in the use of Microsoft Word and Excel; Ability to organize own work and prioritize different assignments; Attention to detail and accuracy in work; Respect established timelines, expectations, priorities, and objectives; Versatile and comfortable in a multitasking environment Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero only accepts applicants who can legally work in India.
The Power BI Developer is responsible to design proper data models that support business analytics, proper workspace management, governance, data security, source code management and Power BI (PBI) administration. The Developer leverages best practices for developing high-quality datasets and visually stunning reports to ensure informed data-driven decision-making. Responsabilities More specifically, the Power BI Developer must: Collaborate with business stakeholders to understand their data requirements and business questions and translate them into effective visual date-driven Power BI dashboards and reports. Develop reports and dashboards that encourage user self-sufficiency and provide actionable insights. Utilize expertise in Power BI development to create interactive visualizations, dashboards, and KPI scorecards that adhere to modern UI/UX best practices. Create insightful reports, carefully crafted visualizations, interactive dashboards, and performance-driven KPI scorecards by utilizing cutting-edge visualization techniques. Extract, transform, and load (ETL) data from multiple sources, ensuring data accuracy, consistency, and reliability for reporting purposes. Utilize Power Query to shape, clean, and transform raw data into usable formats. Apply your experience, particularly SQL Server, to design, optimize, and maintain database structures that support efficient data storage and retrieval. Monitor and enhance the performance of Power BI reports and dashboards, optimizing queries, data refresh schedules, and overall user experience. Proactively monitor and evaluate the impact of monthly Power BI releases, ensuring that the organization stays up-to-date with the latest features and enhancements. Proficiently configure and manage the Microsoft Power BI Service environment to ensure optimal performance, security, and user satisfaction. Conduct training sessions for end-users to empower them to effectively navigate and utilize Power BI dashboards. Provide technical support and troubleshoot issues related to Power BI reports and data visualizations. Requirements: EDUCATION Bachelor’s degree in computer science, business; or science, technology, engineering, mathematics or equivalent preferred. Microsoft Power BI Certification is considered and asset. Experience Minimum of four (4) years’ proven experience as a Power BI Developer or similar role, with a strong portfolio showcasing impactful dashboards and reports. Knowledge And Skills In depth knowledge of Power BI, daily use, setup, configurations and best practices. Expert level in designing and developing BI reports/dashboards. Understanding of the Microsoft services environment. Ability to document, design and model solutions and explain, present and discuss with internal and external teams. Experience with the Microsoft BI stack, including SQL, Power BI, Power Query, DAX and M. Good communication skills; fluent English (oral & written) required. The position will train and support users in all our global offices. Very customer focused and professional. Excellent time management and organizational skills. Must be detail oriented, and able to work independently and self-prioritize tasks. Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule / work schedule Home-based position Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Project Assistant works with Project Managers, Project Coordinators and Clinical Research Associates (CRA) at many stages during clinical studies. Works independently to coordinate and manage study deliverables and administrative tasks, as required by the project team. More specifically, the Project Assistant must: Participates and supports the project team for assigned studies with administrative tasks Assists with maintenance of projects within the CTMS (i.e., trackers, contacts, etc.) Verification and tracking of vendor and site invoices Reconciles project team training against project specific training matrix Follow-ups with team members for completion of the their project specific training Assists with initiating and maintaining study files (eTMF) Filing of email correspondences in eTMF Supports with management of requests for system accesses Supports the project coordinators with tracking, uploading and entering metadata for the site regulatory documents May assist with tracking and review of the site close-out documents May be assigned to the management of the study specific training in SOLABS May update enrolment tracker (screened, randomized, screen failed) for assigned studies May download site visit reports and site letters from CTMS and send for upload to eTMF May assists with project tracking activities and status reports preparation May support other groups within the Project Management department with various administrative tasks Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project team Requirements: Experience in clinical research and in biotechnology, pharmaceutical, and/or CRO industry is an asset. Proficient in English (oral and written) Good knowledge and competency in Word, Excel, and PowerPoint. Ability to prioritize multiple assignments to meet deadlines. Attention to detail. Quick learner, good adaptability and versatile. Strong organizational, communication, problem-solving and multi-tasking skills Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The eCOA and RTSM Application Specialist is responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions—including ePRO, eConsent, and other patient-centric electronic data capture tools— and of Randomization and Trial Supply Management (RTSM) across global clinical studies. This role collaborates with cross-functional teams, Sponsors, and external vendors to ensure that eCOA and RTSM systems are implemented in alignment with study protocols, regulatory expectations, and industry standards. The eCOA and RTSM Specialist acts as a subject matter expert throughout the study lifecycle to ensure reliable data collection, optimal user experience, and data integrity. Responsibilities More specifically, the eCOA and RTSM Application Specialist must: Act as cCOA and RTSM subject matter expert during study start-up, maintenance, and close-out. Define functional requirements and participate in the design and configuration of eCOA and RTSM solutions. Draft and maintain system specifications, user requirements, edit checks, notifications, and reporting requirements. Assist with the design of eCOA-related Case Report Forms (CRFs). Create User Acceptance Testing (UAT) test scripts and coordinate or perform system validation testing. Validate eCOA logic, rules, and study calculations against protocol requirements. Support CDISC-compliant data mapping and collaborate with Clinical Data Standards teams. Contribute to the development of data cleaning strategies and review relevant plans (e.g., DMP, edit check specifications). Prepare study-specific training materials (site guides, participant instructions, etc.) and support training delivery as needed. Lead or participate in internal and sponsor meetings related to system setup, changes, and issue management. Document system configuration and file eCOA and RTSM deliverables into the Trial Master File (TMF). Manage updates, amendments, and change requests throughout the study lifecycle. Troubleshoot issues, escalate risks, and ensure timely resolution with vendors and project teams Ensure eCOA and RTSM activities comply with ICH-GCP, FDA, EMA, and other relevant regulatory standards. Contribute to SOPs, work instructions, process improvement initiatives, templates, and eCOA and RTSM standards. Support continuous improvement, training, and knowledge sharing within Clinical Data Management. Stay current on emerging eCOA and RTSM technologies, regulatory trends, and best practices. Support vendor evaluation, standardization, and relationship management when applicable. Act as a resource for cross-functional teams regarding cCOA and RTSM processes, timelines, and risks. Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training Requirements: PROFILE Bachelor’s degree in Life Sciences, Computer Science, Health Sciences, or related field. 3–5 years of experience in eCOA, EDC, IRT, or eClinical solutions within a CRO, pharma, or health-technology environment. Strong knowledge of eCOA systems and patient-reported outcomes (ePRO). Solid understanding of clinical trial processes and data management principles (CDISC knowledge is an asset). Experience with system configuration, UAT, edit checks, and validation activities. Ability to collaborate in cross-functional settings and manage multiple priorities. Analytical mindset with strong problem-solving skills. Excellent written and verbal communication skills. Global trial experience and knowledge of regulatory expectations (FDA, EMA, GDPR, HIPAA). Attention to quality and data integrity Technical curiosity and digital mindset Problem solving and escalation awareness Stakeholder communication and collaboration Organization, accountability, and autonomy Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule / work schedule Home-based position Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Clinical SAS Programmer will lead the programming activities for various purposes including SAS Data Listings to be used for data review, Safety Review Listings, Centralized Monitoring Listings and Reports. The Clinical SAS Programmer will also be responsible for production of Key Risk Indicators, working collaboratively across departments to produce quality deliverables within agreed timelines and budget, and assists with development and maintenance of optimal strategies to increase productivity and quality, while decreasing cycle times and costs. In addition, the programmer is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines. More specifically, the Clinical SAS Programmer must: Create SAS Data Review Listings, based on protocol, EDC Database and Data Validation Specs. Create a library of SAS Data Review Listings. Create Safety Review Listings. Actively participates in creating reports and listings to support Centralized Monitoring. Document changes to SAS code, programs, and specifications. Assist in the development of Standard Operating Procedures (SOPs) related to the implementation of data standards. Assist with development and maintenance of strategies to increase productivity and quality, while decreasing cycle times and costs. Requirements: A Bachelor of Science degree is required; Master's degree in Computer Science, Information Technology Systems, Statistics, Engineering, or a related field, an asset; 3 to 5 years of clinical research experience in the biotechnology, pharmacy or CRO industry, including 3 years of SAS programming; Excellent knowledge of regulatory requirements and the drug development process Extended exposure to clinical trial data, SAS data, and database specifications; SAS certification and / or Advance Programmer experience would be assets; Very organized and focused on details, with effective project planning and time management skills; Strong verbal and written communication skills in English; Ability to work in a high-speed environment with proven agility to juggle and prioritize multiple competing demands. Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Site Visit Report Reviewer (SVRR) is responsible for the review and approval of site visit reports within the timebound metrics agreed with the specific Sponsor being reviewed for or SOP agreed. Within this review and approval come the surveillance of both the site and study level performance and quality issues as well as documentation/escalation of the same. This role will be perfect for you if : You enjoy working with a Canadian-owned mid-sized CRO where you can build professional relationships with your colleagues at all levels You bring previous experience in reviewing CRA reports Dermatology is a therapeutic area you enjoy or want to learn more about More specifically, the Site Visit Report Reviewer will: Review and approve site visit reports, including the verification that issues and action items are appropriately documented and addressed in a timely manner and no later than 60 days after the issue was identified. Confirm monitoring is being completed as per CMP and that applicable supporting documentation requirements are being adhered to, i.e., PD Specification Documentation) Follow-up with Clinical Research Associates (CRAs) to ensure compliance with draft and finalization timelines for site visit reports and follow-up letters. Track site visit report and follow-up letter metrics. Maintain an issue escalation log based on observations from the site visit reports and escalate issues to project teams. Discuss with project team the trends observed across site visit reports, CRA performance concerns related to site visit completion and issue resolution, and opportunities to improve site visit report completion guidelines. Requirements: IDEAL PROFILE Education Minimum Bachelor’s degree Experience Minimum 3 years’ experience in the biotechnology, pharmaceutical, and/or CRO industry. Previous monitoring experience as a CRA and/or in reviewing site visit reports is an asset. Knowledge And Skills Solid knowledge of clinical trial operations, ICH /GCP Guidelines and other applicable regulatory requirements. Fluent in English (oral and written) Computer skills including proficiency in the use of CTMS, Microsoft Word, Excel, PowerPoint. Attention to detail and accuracy in work. Strong organizational, communication, problem-solving, and experience time coding to studies in a mindful fashion. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Project Assistant provides administrative and coordination support to the Project Management and Clinical Operations teams throughout various stages of clinical studies. This is an entry-level position, ideal for individuals beginning their career in clinical research. The incumbent works under close supervision to support project deliverables and ensure quality and compliance in study documentation. More specifically, the Project Assistant must: Prepare, review, and submit essential clinical trial and regulatory documents required for site activation under supervision. Assist with the collection, organization, and maintenance of site regulatory documents in CTMS and eTMF. Track and update project timelines, site status, and study milestones in project tracking systems. Support the project team with assembling, shipping, and reconciling Investigator Study Files (ISFs). Assist with study start-up, maintenance, and close-out activities, ensuring proper documentation throughout the trial lifecycle. Maintain project-related logs (e.g., ADI, training, site visit, and correspondence logs). File and organize email correspondence and visit reports in the eTMF to ensure audit readiness. Participate in internal project meetings and take meeting minutes as required. Coordinate the completion and tracking of study-specific training and assist with SOLABS reconciliation. Communicate with internal team members and occasionally external partners for follow-up on outstanding documentation. Provide general administrative and logistical support to Project Coordinators, Project Managers, and Clinical Operations. Adhere to SOPs, Good Clinical Practice (GCP), and regulatory guidelines to ensure compliance. Requirements: College or bachelor’s degree. Experience in clinical research or a CRO/pharma environment is an asset. Proficiency in English (written and oral); bilingualism is an asset. Good knowledge of Microsoft Office (Word, Excel, PowerPoint). Strong attention to detail and organizational skills. Demonstrates learning agility, adaptability, and the ability to manage multiple priorities. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Company benefits package Ongoing learning and development About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Site Visit Report Reviewer (SVRR) is responsible for the review and approval of site visit reports within the timebound metrics agreed with the specific Sponsor being reviewed for or SOP agreed. Within this review and approval come the surveillance of both the site and study level performance and quality issues as well as documentation/escalation of the same. This role will be perfect for you if : You enjoy working with a Canadian-owned mid-sized CRO where you can build professional relationships with your colleagues at all levels You bring previous experience in reviewing CRA reports Dermatology is a therapeutic area you enjoy or want to learn more about More specifically, the Site Visit Report Reviewer will: Review and approve site visit reports, including the verification that issues and action items are appropriately documented and addressed in a timely manner and no later than 60 days after the issue was identified. Confirm monitoring is being completed as per CMP and that applicable supporting documentation requirements are being adhered to, i.e., PD Specification Documentation) Follow-up with Clinical Research Associates (CRAs) to ensure compliance with draft and finalization timelines for site visit reports and follow-up letters. Track site visit report and follow-up letter metrics. Maintain an issue escalation log based on observations from the site visit reports and escalate issues to project teams. Discuss with project team the trends observed across site visit reports, CRA performance concerns related to site visit completion and issue resolution, and opportunities to improve site visit report completion guidelines. Requirements: IDEAL PROFILE Education Minimum Bachelor’s degree Experience Minimum 3 years’ experience in the biotechnology, pharmaceutical, and/or CRO industry. Previous monitoring experience as a CRA and/or in reviewing site visit reports is an asset. Knowledge And Skills Solid knowledge of clinical trial operations, ICH /GCP Guidelines and other applicable regulatory requirements. Fluent in English (oral and written) Computer skills including proficiency in the use of CTMS, Microsoft Word, Excel, PowerPoint. Attention to detail and accuracy in work. Strong organizational, communication, problem-solving, and experience time coding to studies in a mindful fashion. Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule Permanent full-time position Ongoing learning and development Work location Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required. About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.
The Power BI Developer is responsible to design proper data models that support business analytics, proper workspace management, governance, data security, source code management and Power BI (PBI) administration. The Developer leverages best practices for developing high-quality datasets and visually stunning reports to ensure informed data-driven decision-making. Responsabilities More specifically, the Power BI Developer must: Collaborate with business stakeholders to understand their data requirements and business questions and translate them into effective visual date-driven Power BI dashboards and reports. Develop reports and dashboards that encourage user self-sufficiency and provide actionable insights. Utilize expertise in Power BI development to create interactive visualizations, dashboards, and KPI scorecards that adhere to modern UI/UX best practices. Create insightful reports, carefully crafted visualizations, interactive dashboards, and performance-driven KPI scorecards by utilizing cutting-edge visualization techniques. Extract, transform, and load (ETL) data from multiple sources, ensuring data accuracy, consistency, and reliability for reporting purposes. Utilize Power Query to shape, clean, and transform raw data into usable formats. Apply your experience, particularly SQL Server, to design, optimize, and maintain database structures that support efficient data storage and retrieval. Monitor and enhance the performance of Power BI reports and dashboards, optimizing queries, data refresh schedules, and overall user experience. Proactively monitor and evaluate the impact of monthly Power BI releases, ensuring that the organization stays up-to-date with the latest features and enhancements. Proficiently configure and manage the Microsoft Power BI Service environment to ensure optimal performance, security, and user satisfaction. Conduct training sessions for end-users to empower them to effectively navigate and utilize Power BI dashboards. Provide technical support and troubleshoot issues related to Power BI reports and data visualizations. Requirements: EDUCATION Bachelor’s degree in computer science, business; or science, technology, engineering, mathematics or equivalent preferred. Microsoft Power BI Certification is considered and asset. Experience Minimum of four (4) years’ proven experience as a Power BI Developer or similar role, with a strong portfolio showcasing impactful dashboards and reports. Knowledge And Skills In depth knowledge of Power BI, daily use, setup, configurations and best practices. Expert level in designing and developing BI reports/dashboards. Understanding of the Microsoft services environment. Ability to document, design and model solutions and explain, present and discuss with internal and external teams. Experience with the Microsoft BI stack, including SQL, Power BI, Power Query, DAX and M. Good communication skills; fluent English (oral & written) required. The position will train and support users in all our global offices. Very customer focused and professional. Excellent time management and organizational skills. Must be detail oriented, and able to work independently and self-prioritize tasks. Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule / work schedule Home-based position Ongoing learning and development About Indero Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in India.