ERGOMED

Manager

• Leads the team responsible for ICSR management for a selected project or group of projects as Team Leader
• Ensures adequate distribution of tasks for assigned projects and teams and oversees the workflow process
• Assures and exerts of activities leading to effective cooperation with clients in the area of ICSR Management
• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Line Manages assigned ICSR staff
• Creates and maintains project specific KPIs for contracted ICSR activities (this includes optimizing procedures, trainings and any other actions to increase ICSR team efficiency)
• Proposes process changes to ICSR Operational Lead
• Manages ICSR deviations with ICSR Operational Lead support
• Reviews trackers and timesheet data and ensures accuracy
• Is involved in ICSR processing and 2nd QC of cases
• Operates as the assigned team SME and supports other SMEs

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management Position

Director

• Provides oversight and serves as an escalation point for designated projects
• Accountable for the mentoring and supervision of assigned Project Managers
• Developing successful relationships with customers and clients
• Maintaining relationships with assigned clients to drive increased volume of business
• Identifying opportunities for process improvement and communicating with project teams
• Providing regular feedback to senior management on project status, client satisfaction and staff issues
• Supporting development and updating Ergomed Standard Operating Procedures (SOPs)
• Contributes in qualifying and selection of company vendors

Project Director / Associate Project Director

• The Clinical Team Manager will be responsible for site level operational study management
• The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
• Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments
• Developing, reviewing and revision of project documents (e.g., clinical monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
• Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.

Clinical Team Manager – Spanish, LATAM Experience

• Provides oversight and serves as an escalation point for designated projects
• Accountable for the mentoring and supervision of assigned Project Managers
• Developing successful relationships with customers and clients
• Maintaining relationships with assigned clients to drive increased volume of business
• Overseeing Clinical team in India
• Serving as a liaison with Business Development; providing expert project management , clinical, country specific input into new business budget development and Bid Defense meetings
• Acts as key client escalation contact for designated projects
• Actively identifying opportunities for process improvement and communicating with project teams
• Provide regular feedback to senior management on project status, client satisfaction and staff issues
• Supporting development and updating Ergomed Standard Operating Procedures (SOPs)
• Contributes in qualifying and selection of company vendors

Clinical Project Director / Associate Project Director

QA Engineer

• Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA function
• Hosts onsite and remote audits
• Provides support for regulatory inspections of clients
• Assists in scheduling client requests for audits/inspection support
• Supports Quality in the tracking of audit status and deliverables
• Supports Quality in the compilation and reporting of metrics and KPIs
• Collects and collates data from systems and sources
• Authors reports and summaries
• Supports Quality in the tracking of Deviations and CAPAs
• Facilitates CAPA response and resolution
• Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
• Supports the PrimeVigilance Senior Leadership team as needed.
• Supports other Quality activities as needed.

Quality Assurance Officer

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

Client Quality Manager

Medical Director

• Provides leadership to the global medical function including medical monitoring
• Collaborates with Global Medical Affairs Leadership on the ongoing development of the Department and contributes to the business plan at both the tactical and strategic levels
• Directly and through subordinate staff, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and the Company’s Standard Operating Procedures (SOPs)
• Additionally, this position involves cross-functional communications, strategic planning, and participation in clients’ strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors
• The Medical Director will assist the Head of Medical Affairs in educating, mentoring and developing Ergomed physicians to ensure their competence and confidence in developing their skills to become subject matter experts in medical monitoring
• The role requires active monitoring of costs and project deliverables and interaction with the project managers, project directors and the Head of Medical Affairs
• Additionally, the role must include the review and implementation of efficiency strategies whilst maintaining the highest quality of work

Medical Director – Senior Medical Monitor, Oncology

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project
• Involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

Compliance

• Perform quality control of regulatory intelligence screening of legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
• Provide internal teams and Clients with expertise and guidance on national requirements.
• Ensure compliance with company procedures, processes, training records, systems and any other tools· Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables.
• Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
• Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
• Provide feedback on performance of vendors to aid their assessment.
• Communicate suggestions for changes to departmental/company processes/procedures and contribute to department initiatives.

Regulatory Intelligence and Analytics Specialist

• Supports the (Associate) Director, Quality Assurance by leading all aspects of the design, implementation and management of internal and vendor audits and corresponding Quality Risk Management activities.
• Fosters a culture of quality within the PrimeVigilance organisation and acts as an ambassador for the PV QA department.
• Plays an active role in the preparation, maintenance, and execution of the internal Tactical Audit Program and will lead and/or co-audit, internally.
• Represents PV QA in their interaction and exposure to our clients within PV Operations.
• Develops and maintains a comprehensive Audit Universe.
• Develops and maintains the internal Quality Risk Assessment methodology.
• Leads Quality Assurance activities in relation to procurement and vendor oversight.
• Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.
• Coordinates and contributes to internal system and/or vendor audits initiated by PrimeVigilance, including effective management of pre-audit and post-audit activities.
• Supports the Audit CAPA team in the effective management of CAPAs arising from vendor audits.
• Hosts and supports audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities as agreed with (Associate) Director, Quality Assurance and/or VP of Quality.
• Conducts or coordinates audit documentation peer review and quality control activities.
• Monitors compliance within the organisation to ensure early identification and resolution of quality issues.
• Assesses audit findings and recommendations, and identifies process improvement initiatives via trending data as provided by other Quality teams.
• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management Position

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Associate Case Processing Manager – Line Management

Project Director / Associate Project Director

Clinical Team Manager – Spanish, LATAM Experience

Clinical Project Director / Associate Project Director

Quality Assurance Officer

Client Quality Manager

Medical Director – Senior Medical Monitor, Oncology

Client Quality Manager

Regulatory Intelligence and Analytics Specialist

Quality Assurance and Compliance Manager

Client Quality Manager