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. Brand name: Indero
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. Brand name: Indero
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. Brand name: Indero
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 ResponsibilitiesLead 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 RequirementsBachelors 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
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.
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 Inderos 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 Sponsors 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