Innovaderm Research Inc.

Clinical Research

• Author and contribute to clinical and regulatory documents, including study protocols, statistical analysis plans, clinical study reports, narratives, abstracts, posters, and manuscripts
• Contribute to study design and review informed consent forms
• Review statistical analysis plans and tables, figures, and listings
• Review, analyze, and interpret study data
• Perform online literature searches
• Prepare and review training materials for scientific teams and the company
• Manage medical writing deliverables, stakeholder communication, project issues, and timelines
• Provide scientific, therapeutic, and medical writing expertise during study conduct
• Mentor and train new and junior staff
• Perform quality-control reviews of documents prepared by team members
• Support delivery of scientific affairs commitments on time, within budget, and in compliance with SOPs and regulations
• Contribute to organizational improvements and implementation of new processes and procedures
• Participate in QA or client audits as a scientific subject-matter expert
• Support business development with proposal synopses, bid-defense content, sponsor meetings, and sponsor questions
• Review scientific-affairs assumptions and budgets during RFPs
• Provide scientific support and medical writing for pre-IND and IND submissions
• Provide scientific expertise and potentially lead cross-functional projects
• Perform other assigned responsibilities when qualified and trained

Senior Clinical Scientist

Recruitment

• Manage the full-cycle recruiting process and ensure a smooth, positive candidate experience
• Ensure thorough communication, timely feedback, interviewer preparedness, and effective interview structuring
• Create and support the talent acquisition strategy
• Build relationships with hiring managers to understand hiring needs and execute sourcing and recruiting plans
• Identify position requirements and sourcing strategies
• Coach and lead hiring managers through recruitment best practices
• Coordinate job postings in the Applicant Tracking System and manage candidate statuses
• Identify effective sourcing channels for different positions and skill sets
• Conduct screening interviews and validate skill set, organizational/position/cultural fit, and language; prepare shortlists for hiring managers
• Act as the candidate point of contact throughout the recruitment process
• Maintain talent acquisition application systems and recruitment accounts
• Manage pre-employment processes, including background verification and references
• Support employer branding initiatives
• Establish social media strategies to promote open positions
• Proactively source talent using appropriate platforms
• Develop and update recruiting reports and analytics
• Lead and participate in talent acquisition projects and initiatives
• Prepare offer details for offer letters and employment contracts
• Work closely with the HR Business Partner to support the transition into onboarding
• Support Indero’s recruitment needs as a global clinical research organization focused on dermatology and rheumatology

Senior Talent Acquisition Specialist

• Operationally manage and oversee clinical investigative sites and clinical operations deliverables for clinical trials
• Train and oversee CRA activities, including CRA transitions
• Identify quality issues and trends in site performance and establish corrective action plans
• Ensure adherence to study plans, SOPs, ICH/GCP guidelines, regulations, laws, timelines, and budgets
• Serve as primary sponsor contact for site-specific operational issues and clinical deliverables
• Contribute to internal, sponsor, and investigator meetings
• Manage risk assessments and mitigation execution
• Manage site contacts, site training, monitoring performance, screening, and enrollment oversight
• Track site visit report metrics and assess protocol deviations and action items
• Develop the Monitoring Plan and contribute to study plans, manuals, reference materials, logs, and site instructions
• Prepare and conduct CRA training, coordinate and lead CRA meetings, and conduct quality assessment and co-monitoring visits
• Oversee SQV, SIV, SMV, and COV development, performance, quality, and completion
• Participate in business development activities, including client meetings, bid defenses, RFPs, and RFIs
• Contribute to departmental tools and process improvements
• Track, forecast, and reconcile project budgets and support change orders and financial planning
• Proactively identify issues, present solutions, and support delivery of clinical trials within agreed timelines and budgets
• Apply prior experience to solve complex issues, identify solutions, and analyze outcomes

Clinical Trial Manager

Vice President

• Develop and execute the long-term strategic vision for the Medical Affairs division with the CMSO
• Own the operating budget and P&L for Medical Monitoring and Pharmacovigilance
• Build capability roadmaps for Medical Monitoring and Pharmacovigilance
• Represent Medical Affairs on the Operational Leadership Team and advise the CMSO on medical, scientific, and safety risks
• Drive collaboration across Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Scientific Affairs, and Business Development
• Provide executive oversight of medical monitoring across Indero's clinical trial portfolio
• Lead physician resourcing, including hiring, training, deployment, and performance management
• Maintain medical monitoring SOPs, work instructions, and quality standards
• Escalate complex or high-risk medical monitoring issues and sponsor-facing medical disputes
• Provide strategic and operational oversight of pharmacovigilance, including case processing, signal detection, aggregate reporting, and regulatory submissions
• Ensure compliance with global and country-specific pharmacovigilance obligations
• Lead readiness for PV regulatory inspections and internal audits
• Partner with sponsors on PVAs and SDEAs
• Partner with Business Development on RFPs, client presentations, bid defenses, pricing, and new business
• Serve as senior medical point of contact for key sponsor accounts
• Represent Indero in scientific and industry forums
• Ensure Medical Affairs compliance with regulations, the QMS, and sponsor requirements
• Own Medical Affairs SOPs, quality plans, CAPA plans, and audit/inspection responses at executive level
• Lead, mentor, and develop the multidisciplinary Medical Affairs team
• Establish workforce planning, career pathing, succession planning, leadership development, performance frameworks, and KPIs

Vice President, Medical Affairs

• Develop and execute the long-term strategic vision for the Medical Affairs division with the CMSO
• Own the operating budget and P&L for Medical Monitoring and Pharmacovigilance
• Build capability roadmaps for Medical Monitoring and Pharmacovigilance
• Provide executive oversight of medical monitoring across the clinical trial portfolio
• Lead physician resourcing, including hiring, training, deployment, and performance management
• Maintain medical monitoring SOPs, work instructions, and quality standards
• Escalate complex or high-risk medical monitoring issues
• Provide strategic and operational oversight of Pharmacovigilance, including case processing, signal detection, aggregate reporting, and regulatory submissions
• Ensure compliance with global and country-specific pharmacovigilance legislation
• Lead PV regulatory inspection and internal audit readiness
• Partner with sponsors on pharmacovigilance agreements and safety data exchange agreements
• Partner with Business Development on new business, RFP responses, client presentations, and bid defenses
• Develop strategic client relationships and serve as senior medical contact for key accounts
• Lead competitive pricing models for Medical Affairs services
• Ensure compliance with regulations, the QMS, and sponsor requirements
• Serve as executive signatory and accountability owner for SOPs, quality plans, CAPA plans, and audit/inspection responses
• Lead, mentor, and develop a multidisciplinary Medical Affairs team
• Establish performance frameworks, KPIs, succession planning, and leadership development programs

General

• Maintain the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial
• Review and process TMF records through quality control workflows
• Review TMF records for completeness, accuracy, and quality prior to approval
• Classify records and assign appropriate metadata based on record type
• Identify quality issues and issue pre-approval queries
• Coordinate with submitters to ensure timely resolution of queries
• Participate in TMF quality reviews and address assigned findings
• Maintain study milestones and expected document lists
• Support the TMF Project Lead in generating monthly TMF metrics and related reports
• Attend internal TMF Focus meetings and provide updates on TMF status, issues, and outstanding queries
• Collaborate with project team members to resolve issues impacting TMF records

TMF Document Coordinator I

• Manage the full-cycle recruiting process, ensuring a smooth and positive candidate experience
• Ensure effective candidate communication, timely feedback, interviewer preparedness, and interview structuring
• Create and support the talent acquisition strategy
• Develop relationships with hiring managers and execute sourcing and recruiting plans
• Identify position requirements and sourcing strategies
• Coach and lead hiring managers through recruitment best practices
• Coordinate job postings in the Applicant Tracking System and manage candidate status movement
• Identify sourcing channels for different positions and skillsets
• Conduct screening interviews and prepare shortlists for hiring managers
• Act as point of contact for candidates throughout recruitment
• Maintain talent acquisition application systems and recruitment accounts
• Manage pre-employment processes, including background verification and references
• Support employer branding initiatives
• Establish a social media strategy to promote open positions
• Proactively source talent using appropriate platforms
• Develop and update recruiting reports and analytics
• Lead and participate in talent acquisition projects and initiatives
• Prepare offer details for offer letters and employment contracts
• Work with the HR Business Partner to support transition into onboarding

Senior Talent Acquisition Advisor

Medical Billing and Coding

• Perform accurate coding of medical terms and medications using MedDRA, WHO Drug, and company standards
• Coordinate assignment of appropriate dictionaries to meet study requirements
• Develop and maintain coding guidelines
• Review and provide input to the Coding section of the Data Management Plan
• Perform dictionary up-versioning and synonym list upgrade activities
• Validate and test coding setup and programming of coding reports
• Test databases, edit specifications, or related programming activities as needed
• Conduct data review
• Write and resolve data clarifications
• Comply with core operating procedures and work instructions
• Perform other duties as directed by the Lead Data Manager
• Meet assigned objectives
• Develop and maintain good communications and working relationships with the Data Management team

Clinical Data Coder

• Provide general data management support to project teams, sponsors, and external vendors
• Develop eCRF specifications, including data capture screens and edit check specifications
• Program, maintain, validate, and test clinical databases and EDC systems
• Develop eCRF completion guidelines and training materials
• Train site users and monitors on clinical databases
• Develop data transfer agreements and specifications with external-data vendors
• Reconcile external data with EDC data and sponsor safety databases when needed
• Support development of external clinical data systems such as ePRO and IWRS and document/test data transfers
• Develop data management plans and related documentation
• Perform ongoing data review and cleaning through database lock/close
• Code medical terms in clinical databases as required
• Generate data listings and reports for data review and database close/lock
• Monitor study status and provide data status reports
• Maintain complete and current data management documentation in the TMF
• Activate/deactivate database users and maintain request records
• Respond to users needing EDC system assistance
• Archive clinical databases and related documents
• Participate in writing and updating data management SOPs
• Mentor and train a Clinical Data Coordinator
• Oversee outsourced vendors to ensure timelines, deliverables, sponsor requirements, protocol requirements, work orders, and SOPs are met

Clinical Data Manager

Compliance

• Provide project administrative support to regulatory project team members in regulatory affairs and eTMF operations
• Upload and maintain documentation in the CTIS EMA portal for initial applications, amendments, and notifications
• Maintain submission components and track regulatory timelines
• File CTIS documentation to the eTMF
• Prepare redactions of Part II and selected Part I documents for CTIS submission
• Prepare IRB-related documentation for eTMF filing
• Support user requests and site creation for IRB portals
• Reconcile eTMF user access lists against employee lists periodically
• Prepare project documentation for ethics and regulatory submissions
• Prepare, maintain, and update regulatory trackers for assigned studies
• Verify, reconcile, and track vendor invoices for ethics services
• Compile and format Clinical Study Reports and appendices for electronic submissions, including PDFs, bookmarks, hyperlinks, and eCTD
• Assist with initiating, maintaining, and reviewing the eTMF
• Assist with project tracking activities and status report preparation
• Perform other administrative tasks required by project goals and team needs

Regulatory Project Assistant

Project Manager

• Serve as the primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls
• Oversee and actively participate in preparing study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports
• Participate in planning and conducting the Investigator’s Meeting
• Ensure each site has necessary study materials, including investigational product, study supplies, special equipment, and safety lab kits
• Ensure assigned studies are audit ready at all times
• Monitor the quality of study deliverables, including vendor and SubCRO deliverables, and address issues
• Manage risks and control measures to assure project quality
• Analyze discrepancies between planned and actual results
• Review and approve responses to quality assurance audits
• Control project budgets and internal hours allocated to activities
• Identify out-of-scope activities for change orders
• Manage clinical trial timelines, budgets, resources, and vendors
• Coordinate tasks and deliverables across functional departments
• Communicate with study team members, functional departments, and senior management
• Manage and report recruitment status and highlight initiatives needed to meet recruitment timelines
• Lead the core project team, including Associate Project Managers, Project Coordinators, and Project Assistants
• Ensure team members receive adequate project training
• Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams and vendors

Senior Project Manager – Dermatology/Rheumatology

• Serve as the primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively
• Oversee and actively participate in preparing study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports
• Participate in planning and conducting Investigator Meetings
• Ensure each site has the necessary materials, investigational products, supplies, equipment, and safety lab kits
• Ensure assigned studies are audit ready at all times
• Monitor the quality of study deliverables, including vendor and SubCRO deliverables, and address issues
• Manage risks and control measures to assure project quality
• Analyze discrepancies between planned and actual results
• Review and approve responses to quality assurance audits
• Control project budgets, including internal hours allocated to activities
• Identify out-of-scope activities for change orders
• Proactively manage trial timelines, budgets, resources, and vendors
• Coordinate tasks and deliverables across functional departments
• Communicate with study team members, functional departments, and senior management
• Manage and report recruitment status and identify initiatives needed to meet recruitment timelines
• Lead the core project team, including Associate Project Managers, Project Coordinators, and Project Assistants
• Ensure all team members receive adequate project training
• Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams and vendors to complete deliverables on time and according to applicable standards

Software Engineer

• Lead single and/or multiple clinical trials as Lead Statistical Programmer
• Develop, maintain, and validate annotated Case Report Forms (aCRFs)
• Develop, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets or derived datasets, Tables, Listings, and Figures (TLFs)
• Prepare submission packages for DMC data review meetings, Interim Analyses, and Clinical Study Reports
• Review and provide input into Statistical Analysis Plans, TLF Shells, eCRFs, edit checks, and other Data Management documents
• Support data cleaning by programming, reporting, reviewing, and closing statistical data issues
• Develop and validate SDTM and ADaM define.XML/.PDF files and reviewer guides
• Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21
• Use global SAS macros to improve programming efficiency
• Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses
• Contribute to and participate in internal initiatives involving standard macros, templates, programming standards, and processes
• Collaborate with Biostatistical study teams and other departments to deliver high-quality work within timelines and budget
• Ensure compliance with ICH guidelines, pharmaceutical industry standards, regulatory requirements, and company SOPs
• Keep current with industry, CDISC, ICH, and regulatory standards
• Mentor more junior Statistical Programmers as needed

Senior Statistical Programmer

• Lead single and/or multiple clinical trials as a Senior or Lead Statistical Programmer.
• Develop, maintain, and validate annotated Case Report Forms (aCRFs).
• Develop, maintain, and validate specifications and statistical programming for SDTM datasets, ADaM datasets or derived datasets, Tables, Listings, and Figures (TLFs).
• Prepare submission packages for DMC data review meetings, Interim Analyses, Clinical Study Reports, and other purposes.
• Review and provide input into Statistical Analysis Plans, TLF Shells, and Data Management documents such as eCRFs and edit checks.
• Support Data Management with data-cleaning activities, including programming, reporting, reviewing, and closing statistical data issues.
• Develop and maintain SDTM and ADaM define.XML/PDF files, clinical SDTM Reviewer’s Guides, and ADaM Reviewer’s Guides.
• Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
• Use global SAS macros to improve programming efficiency.
• Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses.
• Collaborate with Biostatistical study teams and cross-functional departments to deliver high-quality work within timelines and budget.
• Contribute to and participate in internal initiatives involving standard macros, templates, programming standards, and processes.
• Mentor more junior Statistical Programmers as needed.
• Keep current with industry and CDISC standards, ICH guidance, and regulatory requirements.

• Lead single and/or multiple clinical trials as a Senior Statistical Programmer.
• Develop, maintain, and validate annotated Case Report Forms (aCRFs).
• Develop and maintain specifications and perform statistical programming for SDTM datasets, ADaM datasets or derived datasets, Tables, Listings, and Figures (TLFs).
• Prepare submission packages for Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), Clinical Study Reports (CSRs), and other purposes.
• Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management documents such as eCRFs and edit checks.
• Support data cleaning activities by programming, reporting, reviewing, and closing statistical data issues.
• Develop and validate SDTM and ADaM define.XML/PDF files and reviewer guides.
• Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
• Use global SAS macros to improve statistical programming efficiency.
• Act as an Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and interim analyses.
• Collaborate with Biostatistical study teams and cross-functional departments to deliver high-quality work within timelines and budget.
• Mentor junior Statistical Programmers as needed.
• Participate in internal initiatives involving standard macros, templates, programming standards, and processes.
• Keep current with industry, CDISC, ICH, and regulatory standards and requirements.