Project Manager and SCRUM MASTER

6/2022 – offen

Managing clinical study projects in a timely manner in adherence with ICON’s SOP’s, ICH, GCP and appropriate regulations and liaising with other department managers as necessary
Delivery of clinical study projects in accordance with the contract, timelines and study budget
Identification and review of change orders for budget
Developing contingency plan and risk mitigation strategies to ensure successful delivery of project goals.
Attending and presenting at client Investigator, Kick-Off and client meetings
Co-Development and maintenance of study PM tools
Ensuring all necessary study specific trainings are provided to study teams to improve performance and knowledge. Providing coaching / mentoring as necessary
Management of eCRF development process
Development/ Review/ Maintenance of all trial documentation (Charter, eCRF, SRS, Reviewer Training Manuals, Trial Master files)
Coordinating User Acceptance Training and demonstration of eCRF
Acting as primary client and CRO contact and developing successful working relationships
Preparation and management of meeting agendas and minutes
Preparing / Approving Project Reports and Data reconciliation
Coordinating reader trainings, review sessions & managing study centers
QC & Monitoring Offsite Assessments/Blinded Reads and supporting internal, client, and regulatory audits
Ensuring all management/tracking systems are up to date
Providing regular feedback to senior management on project status, client satisfaction and staffing issues
Data Management Lead for scheduling and preparation of data deliveries as required
Participating in BD activities and Interviews as appropriate

PMO

7/2021 – 7/2022

Monitoring and managing of early-stage drug discovery projects (Targets to Hit identifications).
Ensuring the timely delivery of client projects according to specified quality criteria and budget
Working at the interface between Crelux scientific project leaders and clients
Providing project oversight, guidance, and customer relationship management
Monitoring and reporting of all aspects of projects including progress, project profitability, forecasted hours, risks, and critical issues
Organizing and managing project team meetings, leading team discussion, issuing and distributing minutes, tracking action items and updates
Supporting building a network with internal stakeholders and external collaborators, academics, conducting interactions with customers, internal and external expert to improve Crelux & WuXi AppTec services (Protein Production, Biophysical Assays- Fragment Screening & FBDD, Crystallography, DEL Screening)
Business development activities i.e. capabilities presentation

Biochemie

8/2019 – 5/2021

Providing concept validation and maturation-specific support as a scientific lead, contributing to developing technical package of new business proposition and Stage-Gate reviews
Designing and Developing innovation prototypes. Providing clear project plans along with milestones and deliverables.
Providing regular status, stage-gate updates and report outs to stakeholders and leadership
Supporting building a network with internal stakeholders and external collaborators, academics, conducting interactions with customers, internal and external experts to implement innovation in pilot market, creating a plan to adapt to further markets and scale globally
Preparing technical validation reports and presentations in innovative solutions and project related topics within early phase of drug discovery. Supporting drafting of MOA with external collaborators and working closely with Intellectual property
Supporting portfolio management and preparation of portfolio reviews e.g. by collecting market data, literatures, patent analysis, providing data and information to enable business decisions in healthcare technologies.

Business Intelligence and Reporting Tools (BIRT)