ERGOMED

Learning and Development

• Support colleagues and functional teams in developing, managing, and implementing Controlled Procedures
• Support GxP activities to ensure compliance with applicable legislation, guidelines, and standards
• Provide guidance on GxP Quality Operations and Training procedures and requirements
• Support GxP training activities across the Ergomed group
• Help ensure training is efficient, effective, and tracked to completion
• Partner with Learning and Development to assist in developing effective training
• Assist in triage and management of access to the Quality Management System
• Participate in projects improving Quality Management System use and management
• Manage access requests to Controlled Systems for employees and clients
• Assist with Business Continuity activities across the Ergomed Group
• Support audits and inspections by supplying reports or procedures
• Prepare and analyze Quality Operations and Training metrics and periodic management reports
• Assist with CAPA or Deviation records resulting from process issues
• Foster a collaborative, high-performing quality culture across global teams and regions
• Provide coaching and professional development support for team capability and succession planning

Quality Associate, Quality Processes – GCP Training Coordinator

Compliance

• Complete study start-up and regulatory deliverables according to the SSU RA management plan
• Liaise with SSU/regulatory project teams, authorities, vendors, and investigative sites
• Independently manage low-complexity study start-up activities under senior guidance
• Prepare, collect, review, and submit regulatory information to national authorities and ECs/IRBs
• Collect, review, and track essential documents for site initiation and activation
• Investigate incomplete, inaccurate, or missing documents
• Prepare study team reports and updates on essential document status
• Draft, negotiate, finalize, and execute clinical site and ancillary agreements and amendments
• Conduct site outreach and manage confidential disclosure agreements
• Coordinate documents and activities leading to investigational product release, site activation, and site initiation
• Review labels, patient information sheets, diary cards, insurance, and related documentation for ICH GCP and country-specific compliance
• Arrange and review translations of essential documents
• Contribute to regulatory and study start-up strategies and plans
• Complete project trackers, study portal and TMF filing, and submission dossier QC
• Ensure deliverables and essential document submissions meet project timelines, expectations, SOPs, and study-specific requirements

Specialist, Study Start Up – Regulatory Affairs

Manager

• Manage a team of Statistical Programmers
• Oversee project quality, budgets, timelines, and resourcing
• Coordinate statistical programming activities across clinical development projects
• Oversee creation and review of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs)
• Provide feedback, coaching, mentoring, and development support to team members
• Participate in performance management and assessment of new team members
• Develop best practices, controlled documents, templates, and reusable work products
• Maintain knowledge of industry expectations and best practices
• Identify departmental issues and work with senior leadership on resolutions
• Oversee a portfolio of studies and ensure delivery on time, within budget, and to client expectations
• Act as a senior reviewer and support Statistical Programming work
• Lead or support creation of complex or high-priority client deliverables
• Represent Statistical Programming to internal leadership and external organizations, including audits, bid defenses, and conferences
• Support the Director, Biostatistics with corporate goals, department development, industry trends, resource forecasting, planning, metrics, and KPIs
• Lead special projects to improve departmental efficiency, profitability, and operational excellence
• Develop team goals and expectations and support hiring strategies
• Manage project financials for studies led by direct reports
• Plan and coordinate statistical programming for regulatory submission integration work
• Consult with internal teams on statistical programming for clinical trials across therapeutic areas

Manager, Statistical Programming – Line Management, SDTM Datasets, ADaM Datasets, TLFs

Associate

• Handle medical information enquiries in English and Italian
• Conduct pharmacovigilance activities, including initial intake of adverse events
• Provide approved responses to medical enquiries from healthcare professionals and patients
• Assist pharmaceutical clients’ internal departments with medical information queries
• Act as a call handling agent for the dedicated Medical Information call center
• Prepare enquiry responses through literature research and collaboration with internal and client physicians
• Participate in out-of-hours medical information services for clients with 24/7 enquiry handling

Medical Information Associate – Italian Language

• Handle medical information enquiries in English and Italian
• Perform pharmacovigilance activities, including initial intake of adverse events
• Provide approved responses to medical enquiries from healthcare professionals and patients
• Assist pharmaceutical clients’ internal departments with medical information queries
• Act as a call handling agent for the dedicated Medical Information call center
• Prepare enquiry responses through literature research and collaboration with internal and client physicians
• Participate in out-of-hours medical information provision for clients using 24/7 enquiry handling services
• Assist in the growth of the medical information department

• Lead the team responsible for ICSR management for selected projects or groups of projects as Team Leader
• Ensure adequate task distribution for assigned projects and teams and oversee workflow processes
• Drive effective cooperation with clients in ICSR Management
• Provide support to project-team activities undertaken on behalf of clients and the company
• Line-manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, training, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Serve as the assigned team subject matter expert and support other SMEs

Associate Case Processing Manager – Line Management

• Lead the team responsible for ICSR management for selected projects or groups of projects as Team Leader
• Ensure adequate distribution of tasks for assigned projects and teams and oversee workflow processes
• Drive activities leading to effective cooperation with clients in ICSR Management
• Provide support to project-team activities undertaken on behalf of clients and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Operate as the assigned team subject matter expert and support other SMEs

• Lead the team responsible for ICSR management for selected projects as Team Leader
• Ensure adequate task distribution and oversee workflow processes
• Promote effective cooperation with clients in ICSR Management
• Support other project-team activities undertaken for clients and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings, and actions to improve ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Act as assigned team subject-matter expert and support other SMEs

• Lead the team responsible for ICSR management for selected projects or groups of projects
• Ensure adequate task distribution and oversee workflow processes
• Drive effective cooperation with clients in ICSR Management
• Support other project team activities undertaken for clients and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, training, and other actions to improve ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Operate as the assigned team subject matter expert and support other SMEs

• Lead the team responsible for ICSR management for selected projects or groups of projects as Team Leader
• Ensure adequate task distribution for assigned projects and teams and oversee workflow processes
• Support effective cooperation with clients in ICSR Management
• Provide support to other project-team activities undertaken on behalf of clients and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Act as assigned team subject matter expert and support other SMEs

• Lead the team responsible for ICSR management for selected projects as Team Leader
• Ensure adequate distribution of tasks across assigned projects and teams
• Oversee workflow processes
• Support effective cooperation with clients in ICSR Management
• Provide support to project team activities undertaken on behalf of clients and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, training, and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Act as assigned team subject matter expert and support other SMEs

• Lead the team responsible for ICSR management for selected projects or groups of projects as Team Leader
• Ensure adequate task distribution for assigned projects and teams and oversee workflow processes
• Ensure effective cooperation with clients in ICSR Management
• Provide support to project team activities undertaken on behalf of clients and the company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, deliver trainings, and implement actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second quality control of cases
• Operate as the assigned team subject matter expert and support other SMEs

• Responsible for operational project management
• Proactively identify, resolve/mitigate, and escalate risks and issues
• Verify and ensure project team members are trained
• Develop, review, and revise project documents
• Initiate corrective/preventative measures where necessary

Clinical Team Manager – Spanish Language Required

• Provides leadership and oversight for a global team of Statistical Programmers
• Ensures the delivery of high-quality work that meets established timelines, budget expectations, industry standards, and internal processes
• Manages and coordinates statistical programming activities across clinical development projects
• Coaches, mentors, and develops team members
• Contributes to departmental process improvements, standards development, and strategic initiatives

Manager, Statistical Programming – SDTM datasets, ADaM datasets, TLFs

Project Manager

• Ensure that projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards
• Liaise with project team members, provide training where needed and ensure correct allocation to tasks
• Develop, review and edit project plans to assure consistency with goals and milestones
• Organization and facilitation of project meetings related to study activities (study organization, initiation, execution, closure)
• Serve as primary point of contact with sponsor and Ergomed Senior Management on project status
• Represent Ergomed at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies and for committee meetings, (e.g.EC/IRB)
• Develop review and edit of relevant SOPs to assure consistency with Regulatory standards and develop study related training programs to support this.
• Contribute to bid defense activities

Quality Associate, Quality Processes – GCP Training Coordinator

Specialist, Study Start Up – Regulatory Affairs

Manager, Statistical Programming – Line Management, SDTM Datasets, ADaM Datasets, TLFs

Medical Information Associate – Italian Language

Medical Information Associate – Italian Language

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Clinical Team Manager – Spanish Language Required

Manager, Statistical Programming – SDTM datasets, ADaM datasets, TLFs

Project Manager, Sr. Project Manager – Oncology Experience Required