Basel, Basel, Switzerland
Projektmanagement & Coordination Projektüberwachung, Kostenkontrolle, SAP-gestützte Projektsteuerung, umfassendes PO-Tracking, Reporting Pharma / Klinische Studien Dokumentenmanagement (GCP-konform), CTD/CSR-Unterstützung, Trial-Koordination, regulatorische Prozesse Administrative Exzellenz Terminkoordination, Ressourcenplanung, Budgetüberwachung, vollumfängliches Rechnungs- und Bestellwesen IT-Systeme & Tools SAP, ARIBA, MDG, eShop, Microsoft 365 (Word, Excel, PowerPoint, Teams, Outlook), Fieldglass, Lotus Notes, branchenspezifische Anwendungsinstrumente Prozesse & Compliance Einhaltung interner & externer SOPs, Qualitätssicherung, Audit-Vorbereitung, Dokumentationspflichten Kommunikation & Leadership Interdisziplinäre Schnittstellenfunktion, internationale Teamführung (CH, JP & USA), Schulungsleitung, Empathie, Sozialkompetenz Sprachen Deutsch (Muttersprache), Englisch (verhandlungssicher), Französisch (Grundkenntnisse) Soft Skills Zuverlässigkeit, Eigeninitiative, Belastbarkeit, Pragmatismus, strukturierte Arbeitsweise, Lernbereitschaft, hohe Selbstmotivation
Project Support Team Coordination & Controlling: - Coordinated the "Project Support Team – Controlling and Procurement" to ensure resource availability (quantity and quality) for project needs. - Acted as the main interface for monitoring third-party personnel purchase orders via Talentflex/Fieldglass, ensuring alignment with service orders and terms from units (Chroma, HVP, MPP, SSP, MBC, etc.) and SU Engineering. - Managed cost planning and schedule tracking, providing advice on critical budget items and milestones. - Updated SAP with actual data (budget, milestones, LE) for consistency across project documentation. - Provided support for budget forecasting, trending, and phasing, advising PMs on financial management. - Monitored project postings (POs, GRs, invoices, rebookings) and guided PMs on actions required. - Assisted PMs with project closure and submission of monthly service records and timesheets. - Collaborated with Pharmaplan to ensure compliance with financial regulations and accounting standards. - Oversaw change orders, rebookings, contingencies, and reserves, ensuring proper documentation. - Addressed project challenges and took action to maintain timelines and cost controls. - Ensured accurate collection and management of procurement-related documents (offers, invoices, POs, PRs). - Assisted PMs with procurement documentation and accurate purchase order submissions. - Supported the preparation of Project Progress Reports, providing actual costs, milestones, and updates. - Delivered reports to the General Planner, including PO overviews and cost control metrics. - Ensured compliance with Novartis financial processes, hourly rate definitions, and business optimizations. - Assisted with monthly accruals, special reports, and tracked projects against budget and LE. - Utilized SAP, ARIBA, MDG and eShop for procurement, cost control, and reporting tasks.
- Leaded and acted as Trial Document Manager, coordinating and ensuring document management resource allocation to specific studies - Setting up and conducting training for Clinical Trial Teams and Study Leads to ensure full compliance with SOPs and Novartis specific requirements and guidelines - Managed and archived clinical documents by collaborating with the line functions. - Retrieved clinical documents and listed available documents for business, legal and regulatory purposes. - Acted as Program Documentation Coordinator ensuring document management resource allocation to program specific studies. - Performed technical quality controls of clinical registration documents. - Maintained electronic document management systems. - Filed, indexed, scanned and processed clinical documentation. - Processed paper and electronic CRFs for HA submissions. - Tracked off-site storage using an electronic indexing system. - Extracted information from clinical trial documentation.- Facilitated compliance by mentoring, training and serving as expert. - Promoted best documentation practice to line functions to ensure that documents created/generated in the course of clinical research were managed and archived in accordance with GCP guidelines and Novartis SOPs/NIPs.
Specialized in Drug Development with a focus on Cardiovascular and Metabolism studies. Proven expertise in administrative and management tasks with an increasing scope of responsibilities. Clinical Trial Results Database (CTRD) Management: Full accountability for supervising and coordinating template requests across all eligible CVM trials, ensuring compliance with current regulations and strict adherence to deadlines. Cross-Functional Communication: Managed correspondence with Publication Managers, Clinical Trial Leaders, Legal and IP departments, and Global Program Leaders to ensure data accuracy and regulatory compliance. Documentation and Compliance: Supported Clinical Study Report (CSR) writing and filing activities, collaborating with Document Operations (DOC) and Medical Writing Groups to meet regulatory requirements. Oversaw archiving and documentation management for submission compliance with international guidelines (GCP, ICH, SOPs, NIPs). Budget Management for Mega-Trials: Supervised budget tracking, Last Estimation (LE) updates, and financial liaison with external vendors. Managed a genotyping sub-study within the VALUE Mega-Trial, including direct project cost forecasting and payment authorizations. Collaboration with Global Partners: Coordinated with Country Pharma Organizations (CPO) and Contract Research Organizations (CROs) for budget oversight, clinical study data updates, and contract negotiations. Maintained comprehensive service agreements and payment processes. Event Coordination and Stakeholder Engagement: Independently organized internal and external events, including liaising with trial advisory committees (Data Safety Monitoring Board, Steering Committee, Consultants). Managed contracts and agreements for Key Opinion Leaders (KOLs) to ensure smooth study operations.
Administrative Associate, Clinical Operations R&D (Women’s Health Care / Endocrinology & Metabolism) Experienced in providing comprehensive administrative support within clinical trials, with a focus on Women’s Health and Endocrinology. Dedicated to ensuring smooth operations and compliance across multiple studies. Support to Global Trial Leaders: Assisted Global Trial Leaders in managing day-to-day administrative tasks, including database maintenance and close collaboration with sister companies to streamline clinical study processes. Clinical Trial Supplies Management: Oversaw forecasting, coordination, and distribution of clinical trial supplies, ensuring availability and adherence to project timelines. International Meeting Coordination: Organized and set up international meetings and conferences, facilitating seamless communication among global stakeholders. Data Management & Compliance: Tracked Data Correction Queries and maintained study documentation in compliance with legal requirements and Standard Operating Procedures (SOPs).
Temporary Assignments in Zug and Zurich Engaged in diverse temporary positions as an Administrative Specialist and Operations Coordinator within various organizations, with a primary focus on streamlining order processing, managing shipping logistics, and overseeing contract execution. Alcari SA Chemicals — Clerk & Traffic Assistant / Chemical Trades Supported various aspects of business development and operational organization, with a specific focus on international chemical trade. Business Development & Organizational Support: Assisted in streamlining internal processes and provided administrative support to enhance overall business operations. Partner Relations & Networking: Focused on building and maintaining business relations with new and existing partners worldwide, supporting efforts to explore potential collaborations in the chemical industry. Logistics & Trade Coordination: Managed the end-to-end logistics process, including the coordination of chemical shipments, compliance with international trade regulations, and handling of import/export documentation. Cavex Caviar Handel / Kompexim — Sales & Trade Specialist Responsible for overseeing caviar trade operations and exploring potential new distribution channels both locally and internationally. Caviar Trade Management: Managed end-to-end caviar sales processes, ensuring high standards of quality control, customer satisfaction, and adherence to trade regulations. Market Expansion & Distribution: Identified and evaluated opportunities for expanding distribution networks, fostering relationships with new partners to enhance market presence domestically and abroad. Client Relations & Sales Support: Provided tailored support to existing clients while proactively developing strategies to attract new customers and boost sales performance.
Import/Export & Logistics Specialist Temporary management of comprehensive business activities focused on Eastern Europe and the former Soviet Union (USSR) markets, with expertise in handling commodities, particularly chemicals and industrial goods. International Order Processing & Logistics: Managed the entire supply chain process, including order fulfillment, shipment coordination, logistics management, letters of credit, and customs declarations, ensuring timely and efficient delivery of goods. Inventory & Stock Management: Oversaw stock supplies, optimized inventory levels, and ensured seamless alignment between supply and demand. General Controlling & Compliance: Conducted financial controlling activities, monitored compliance with international trade regulations, and supported risk management initiatives to ensure smooth business operations.