Freelance Project Manager, CTM & CRA

6/2022 – 12/2022

Sabbatical/Travel/Work against hand

Gebäude Management

10/2020 – 5/2022

The SCPL in Clinical Operations and Data Management tasks are:
• Provides comprehensive operational support for FMI’s
participation in clinical trials sponsored by BioPharma partners,
Academic partners, and FMI led trials
• Manage strategically a portfolio of studies independently and
efficiently
• Developing, implementing, and monitoring the execution plans
for the clinical studies they support from initial study intake
through final project deliverables
• contributing to the design of partner and FMI sponsored
research
• Proactive, clear, and customer-centric communication, day to
day project management, as well as, operational excellence
and oversight of clinical trials.
• Work collaboratively with internal and external stakeholders
across functions to manage samples, timelines, resource
plans, and critical path activities directly impacting the
successful implementation and on-going execution of clinical
studies.

Programm-Management

10/2019 – 9/2020

Lead of a International Clinical Operations Management Team on clinical trials including:
• Actively participates in Study Team meetings, providing up-to-date and concise information on study progress from the clinical operations perspective, identifying important field operations issues that require input from the Team and proposing solutions
• Proactive and close liaison between the field activities in different countries participating studies, consolidating and disseminating important information to international study personnel and the Study Team in a timely manner to guarantee an even level of project relevant knowledge
• At international level, coordinates, oversees and report on the local/regional Clinical Operations Project Managers (COPM) to ensure that study-related activities are conducted according to expected quality, timelines and budget
• Ensure the International Clinical Operations personnel are adequately trained and provide trainings when required
• Lead the execution of the country and center feasibility and consolidates the results/feedback to the Study Team
• Identify in close collaboration with the Study Team leader an appropriate monitoring strategy, develops the Monitoring Plan with input from COPMs, for in-house and outsourced monitoring choices
• Oversee patient recruitment and retention during the study and when necessary, pro-actively works with COPMs to develop and propose action plans to the study team
• Track the quality of the data (Deviations, CAPAs, etc.) and when relevant, report important issues to the Study Team
• Manages the outsourcing to international monitoring CROs (for multi-country studies), including participating in the selection and management of the CRO
• Assists in the preparation of tools and logistic of the study
• Ensure that all necessary study documentation is gathered and correctly stored in the study master file

Medizinforschung, Drug Discovery

8/2017 – 9/2019

Project Management of non-interventional studies (NIS) and clinical
trials including:
• Study coordination in collaboration with a team of PMs, CRAs
and CTAs
• Act as central contact for routine study related issues
• Site Management of participating study sites
• Preparation of documents for the submission and notification
process to competent authorities and ethics commissions and
further processing as necessary
• Coordination and execution of contractual negotiations with the
study sites
• Close collaboration with local Kantar Health affiliates in
multinational projects
• Coordination and supervision of monitoring activities including
review of monitoring reports
• Participation in the creation of study documents (e.g. study
protocol/observation plan, CRF)
• Administration of payment processes
• Compliance with budget and time schedule

Klinische Arbeiten, Klinische Forschung, Forschung

12/2016 – 6/2017

Clinical research activities in clinical trials (Phase II), including:
• Controlling and coordinating of the Project Assistants in the
implementation of multinational study-related activities
• Management of the correct conduct of the clinical project,
interacting with the Sponsor, the internal clinical study team
and the Investigators under the supervision of the Project
Management
• Assuring compliance with local regulations, Code of Federal
Regulations (CFR) / International Conference of Harmonization
(ICH) and GCP guidelines, company and Sponsor SOPs
• Preparation of study submissions to Competent Authorities &
Ethic Committees and further processing as applicable
3
• Performing and organizing of feasibilities for planned studies
• Mentoring, training and motivation of the study sites
• Preparation, initiation, monitoring and close-out of blinded
phase II clinical trials
• Review and verification of clinical study data
• Preparation and continuously updating of study-related
documents
• Performance of administrative study tasks
• Preparation and supervision of inspections and Sponsor audits
• Continuous participation on company- and sponsor-specific
trainings
• Preparation of and attending Investigator Meetings

Klinische Arbeiten, Klinische Forschung, Drug Discovery

11/2015 – 10/2016

Clinical Research & Project Coordinator activities in clinical trials
(Phase I, II & IV) and non-interventional studies, including:
• Controlling and coordinating of the Clinical Research
Associates & Project Assistants in the implementation of
multinational study-related activities
• Management of the correct conduct of the clinical project,
interacting with the Sponsor, the internal clinical study team
and the Investigators under the supervision of the Project
Management
• Review of Monitoring Visit Reports & Follow-Up-Letters
• Mentoring, training and motivation of the study sites
• Review and verification of clinical study data
• Preparation of study submissions to Competent Authorities &
Ethic Committees and further processing as applicable
• Performing and organizing of feasibilities for planned studies
• Preparation, initiation, monitoring and close-out of blinded
clinical trials of phase I, II and IV
• Monitoring the proper implementation of clinical trials in
accordance with the legal requirements, the protocol, SOPs,
WPDs, ICH-GCP -, FDA - and Sponsor guidelines
• Preparation and continuously updating of study-related
documents
• Performance of administrative study tasks
• Preparation and supervision of inspections, and Sponsor audits
• Continuous participation in company- and Sponsor-specific
trainings

Klinische Arbeiten, Klinische Forschung, Drug Discovery

7/2011 – 10/2015

Clinical research activities in clinical trials (Phase I, II & III), including:
• Performing and organizing of feasibilities for planned studies
• Mentoring, training and motivation of the study sites
• Preparation, initiation, monitoring and close-out of blinded and
unblinded clinical trials of phase I-III
• Review and verification of clinical study data Monitoring the
proper conduct of clinical trials in accordance with the legal requirements, the protocol, SOPs, WPDs, ICH-GCP-, FDA -
and Sponsor guidelines
• Preparation and continuously updating of study-related
documents
• Performance of administrative study tasks
• International PPD working group responsible to revise and
improve the electronic PPD Clinical Foundation Program
• Preparation and supervision of inspections, and Sponsor audits
• Continuous participation in company- and sponsor-specific
trainings

Klinische Arbeiten, Klinische Forschung, Medizinforschung, Drug Discovery

10/2009 – 6/2011

Technical leadership in the category:
• Settlement-oriented coding of diagnoses and treatments according to the
"Diagnosis Related Groups (DRG) and inquiries of the medical service of health insurance (MDK) for claims processing
• Training and advice to employees in the DRG coding system
• Statistical evaluation of departmental requests
• Creation of the monthly performance and revenue statistics as
part of the medical controlling
• Support of the Head of the controlling department as part of different routine and project work such as economic analyzes, key figure calculation, preparation of budget negotiations with the health insurance companies and strategic performance planning of the hospital
• Cooperation with the Quality Management department, independent partially preparation of the structured quality report as well self-responsible administration of the IT support process to ensure legally required external quality assurance

Betriebliches Gesundheitsmanagement, Gesundheitsmanagement, Medizinische Versorgung