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