Sylvia Schaffner Email & Phone Number

Amsterdam

As Senior Program Manager, the main responsibility is to ensure (global) access to clinical trials via smooth running digital patient recruitment and pre-screening programs. Acting as the first point of contact for a drug developer related to the patient recruitment and pre-screening services and be responsible for managing the program. This, with full operational support from cross functional departments consisting of Medical Operations, Growth, Product, and Engineering.Key Deliverables • Primary contact person for Oversight of internal and external stakeholders for patient recruitment and pre- screening programs that are developed to boost clinical trial recruitment• Collaborate internally and with BioPharma clients to ensure a smooth-running program and correct reporting• Guidance of more Junior staff members• Developing strong relations and trust with all stakeholders and keep them up to date on the process/progress of programme• Achieving high customer satisfaction• Solutions focused to problem solve operational issues (technical and recruitment wise)• Create detailed timelines including deliverables, milestones and objectives and ensure that deadlines are being met• Contribute to improving Business and Recruitment Strategies

Lelystad, Flevoland, Netherlands

Mainly responsible for ensuring that existing projects are executed on time and to client requirements. Additionallyresponsible for driving company growth and simplifying customer supply chain processes whilst maintaining the highest level of service and patient safety. Report to the Project Management Head and manage Junior PM's, Supply Chain Planners and Back Office AssistantsKey Deliverables• Drive best practices within the PM team to ensure adherence to processes at the highest level of standards.• Provide support to the wider team on complex projects.• Work closely with the Clinical Trial Supply Manager and internal stakeholders to ensure effective communicationbetween inter-departments, and with the Clinical Trial Manager on process improvement implementation.Sourcing, importing and exporting of clinical supplies

South Africa

At the forefront of genomics, flow cytometry, anatomic pathology, and other laboratory techniques, Q² Solutions delivers cutting-edge solutions with continuous investment in extensive testing capabilities. Mainly responsible for managing all laboratory aspects of assigned clinical trial projects for customers and specified programs and acting as a point of contact for customers after study award and throughout the study lifecycle. Ensure work is conducted in line with standard operating procedures, policies, and practices.Key Deliverables • Ensure facilitation of seamless study set-up from protocol and budget review, chairing meetings, developing, and implementing project plans, to assessing risks and action logs by partnering with the Study Setup team and overseeing the protocol-specific documentation preparation.• Participate in the proposal and business development process including bid defense meetings.• Manage Project Management Plan, timelines, and deliverables, and study documentation throughout the project lifecycle.• Manage study scope changes and monitor budget and serve as an escalation point for study-level issues.

Pretoria, Gauteng, South Africa

IQVIA is the largest healthcare data science company and leader in human data science technology and provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including consulting services.Served as point of contact for customers on data management deliverables and was Project Team Lead for 2 studies in therapeutic areas focused on oncology with a budget of approximately €500,000. Reported to the Manager of Clinical Data Management and managed a team (10) including data coordinators, statistical programmers, and medical reviewers.Key Deliverables • With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, and workload projections, and provide technical expertise with guidance, provide input for, and perform direct negotiations with customer, e.g., timelines, financial, process, resources. • Maintain strong relationships and ensure open communications with customers and IQVIA management. • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables. • Establish strong communications with the Data Operations team, functional leads, and project managers. • Serve as the escalation point for unresolved data issues deliverables. • Manage SOW/budget. • With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defence).

South Africa

Mainly responsible for Monitoring the manufacturing process and providing IT and Network Support. Ensure Escalations of logged tickets to provide first-level fixes. • Network and IT support• Monitoring and QC check of all German car manufacturing plants• Raising and escalation of high and critical production issues • Change and Crisis Management

Pretoria Area, South Africa

Responsible for Database Set up for Late Phase Clinical Trials, developing UAT scripts, Protocol Deviation and DMP’s, and leading Data Managers and Data Programmers. Key Responsibilities• Provide leadership and expertise in all aspects of Data Management and Database Programming.• Manage the delivery of all relevant data operations activities from database setup through database lock.• Coordination of the relevant Data Operations team members and their activities across all geographies.• Liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.

Berlin Area, Germany

Key Responsibilities• Participated as Feasibility Strategy Leader to gain business and to deliver quality and predictable clinical trial services by selecting the most appropriate Clinical Trial Specialists• Promoted new business by participating in project bids (attended 30+ Bid Defense Meetings across Europe, Asia). • Provided expertise and consultation to Client Project Teams (6) and Internal Teams (6).• Completed 60+ Feasibility assessments, including a breakthrough study in NASH and urinary incontinence study for Astellas, new clinical business opportunities and operational strategies with the focus on Endocrinology, Oncology and Neurology and Psychiatry in Europe. • Provided expertise in recruitment and site selection and of predictive investigator performance metrics for over 16 projects with over 110 successfully selected sites according to client specifications and across therapeutic areas. • Acted as site contact, develop site selection plans, design, and implement the Feasibility Questionnaire, and ensure site metric performance and tracking.

Berlin, Germany

Reported to the Director of Clinical Trial Translations across Early Phase all the way through to Late Phase Trials handling the entire spectrum of Essential Clinical Trial Documents (eCRFs, Regulatory, Protocol, Monitoring, and Communications Plans).Key Deliverables • Recruit and place linguists/translators, proofreaders for clinical trial documentation projects. • Manage sponsor and CRO translation projects from study start to monitoring and close-out as per client timelines.

United Kingdom

Responsible for managing multiple clinical trial projects to ensure the integration, coordination, and consistency of company processes throughout with an excellent on-time deliverable track record. Reported to the Project Management team lead.Key Deliverables • Managed more than 30 Projects with an average of 7 projects at any given time.• Chair meetings and provide project management leadership across internal and external teams. • Managed the overall process of planning, scheduling, and controlling the project from contract finalization to database lock and project close-out to ensure timely completion of the project. • Acted as point of contact for client queries and gather user requirements for the EDC and Data Management Systems. • Managed budgets and deliverables for assigned projects

United Kingdom

South Africa

South Africa

Master'S Degree, Research And Experimental Psychology

Activities and Societies: Academic Honors Society

Bachelor'S Degree, Hons., Psychology

Bachelor'S Degree, Psychology

Education record