About me

May 2024

In the field of clinical research, there are a lot of possibilities and a lot of freelancers that offer their services and it is not always easy to find the best fit for your project and/or your company. If you consider to work with me, you should know some things about me: I set my standards high and my work ethics are essential to me. You can expect me to be authentic and to speak my mind. Saying that doesn't mean I can't handle criticism myself. On the contrary, I like to know what I am doing wrong and it is essential for me to grow, both personally and knowledge-wise. My error culture is to handle errors openly. Mistakes happen everywhere, where people work. My best practice is, to talk about things that go wrong and see what you can do to correct them and also prevent the same thing from happening in the future. That is why I value communication at eye level. Since you know some of my work ethics by now, you should also know that this is also what I expect from my business partners. Surely, sometimes a job just needs to be done, I totally understand that and I will happily put my hands on it, but if I have ideas to improve things or something is against my ethics, I will still let you know - and I expect you to do the same with me!

Below, you find my CV with my up to date experience in clinical research.

Curriculum Vitae

• Freelancer in clinical research / medical devices since 08/2023
• 11/2023 - ongoing: CRA II at PPD GmbH: 1 Phase Ib-trials in patients with advanced melanoma, one Phase IIb trial in patients with moderate to severe Atopic Dermatitis, 1 Phase II trial in Patients with Head and Neck squamous cancer: support sites in conduct of study, perform SIV, IMV and COVs, participate in Study Team Meetings, report writing, support submission
• 05/2023 - ongoing: Sr. CRA at AstraZeneca GmbH: 2 breast cancer trials Phase III, 1 Phase III Ovarian Cancer study: Support documentat preparation for submission to EC/LA. Perform SIV, IMV, COVs, Prepare and conduct Interim Analysis, acting as POC for all study related questions and issues, write reports, support site invoicing process and train site personnel.
• 02/2023 - ongoing: Quality representative, clinical affairs/research and regulatory person: establishing a working and living Quality management system for the client, creating documents, support in negotiation with potential business/finance partnerships, acting as the main point of contact for US based business contacts. Attending AVACNY Symposium and Teaching Day in NY/Syracuse in November 2023 to present prototypes of peripheral venous catheter (under development)
• 07/2022 - 07/2023: Clinical Project Lead at ICON plc, FSPx, working for client Sanofi, responsible for DACH region. Main tasks and responsibilities: Support of submission of amended protocols and ICFs, translation of local ICFs, review monitoring visit reports, oversee monitoring activities and database lock activities, ensure timelines are kept, oversee study budget, function as point of contact for local vendor issues, support CRAs in issue management, training of CRAs and sites on study matters, procedures and documents.
• 09/2018 - 06/2022: CRA at MSD SHARP&DOHME GmbH, started working as unblinded CRA, after two months takeover of sites in a heart failure trial, Phase III. Main tasks and responsibilities: primary point of contact for PIs and site study staff, preparation of a data interim analysis, maintenance and reconciliation of ISF and eTMF, perform monitoring visits including drug accountability and SDV and report writing for respective visits, closing out sites in this trial. Since 2019, working in oncology trials, in double blind setting, preparing sites for study start and collecting regulatory documents, site initiation and performing respective trainings, supporting sites in study conduct. Being part of a CRA team on a high recruiting site with need of special surveillance by CRAs due to high workload and high level of required support due to changing study team members, offering trainings to new site personnel spread over all studies in progress for MSD. Supporting new employees at MSD in getting started within the company (function as “buddy”)
• 04/2018 - 08/2018: Senior CRA at Covance Clinical and Periapproval Services GmbH, working under contract for MSD Germany as unblinded CRA for oncology trials in several indications and different phases. Main tasks and responsibilities: maintain the blind, primary point of contact for pharmacies, drug accountability and perform corresponding SDV, eTMF reconciliation, preparation for study start
• 03/2017 - 03/2018: CRA II at EastHORN clinical services, main tasks and responsibilities: preparation of submission and regulatory documentation, preparation of contracts and budget proposals, function as main contact for sites, preparing financial tools for payment tracking for european sites as assistant of Project Management, perform close out visits and site selection visits and respective reports, ICF development and translation review.
• 09/2013 - 02/2017: Freelance CRA, main tasks and responsibilities: during a high priority project in dermatology after launch of new medication: motivation of sites to recruit patients, perform motivational visits and calls, build a strong relationship to the sites, all tasks of CRAs (Monitoring visits, report writing), mentoring of new starters, site selection remote monitoring, review of colleagues´ reports of monitoring visits, development of an eCRF in collaboration with the clinical team and programmers/service providers, perform monitoring visits
• 06/2013 - 08/2013: Study Coordinator at Medical School Hannover in the department of gastroenterology, hepatology and endocrinology
• 01/2012 - 05/2013: Study Nurse in the “Klinische Forschung Gruppe Nord (kfgn)” dependence in Hanover/ Germany
• 08/2007 - 12/2011: Nurse at Klinikum Hildesheim GmbH on different wards: orthopedic and accidental surgery, intensive care (cardiac main focus), surgical intermediate care

Education

• University:
  • Master of Science in Clinical Research at Donau Universität Krems. Finished 27 Apr 2018 with granting of the Mac grade.
  • Bachelor of Arts for allied Health Professions with main focus on pedagogy at Diploma Nordhessen. Finished on 02 Oct 2013. Additional module taken in Management.
• Apprenticeship: 01 Aug 2004 - 31 Jul 2007: Nurse at Klinikum Hildesheim GmbH finished with obtaining the title "Registered Nurse"
• School education: Secondary School finishes with passing A-level 2004 at Marienschule Hildesheim

Languages:

• German (mother tongue)
• English (fluent in word and writing)
• Spanish (basic knowledge)
• French (basic knowledge)
• Turkish (very basic knowledge)

Miscellaneous:

• Fulltime GCP training in November 2016, annual online refresher training
• Quality representative course for medical devices manufacturers, completed on 07 May 2024