Clinical Trial Specialist

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TMF Management. CRA, Project Management etc.

• Data Science
• Gute Klinische Praxis
• GXP
• Klinische Arbeiten4 J.
• Programming Language One (PL/I, PL1)
• Python
• Scikit-learn
• TMF Management

I possess great experience in data management, experimental designs, biotech, data analysis and computer program. Matlab, imagej etc. used by researchers. In addition to this, I can carry out clinical safety precautions safely. As you can see from my enclosed resume, I am very skilled in Roles and Responsibilities of the Investigator; Roles and Responsibilities of the Institution; Regulatory Issues e.g. FDA Guidance regarding Clinical Trials, ICH Guideline for Good Clinical Investigators. Performing and coordinating external clinical studies; site selection, protocol development, and closeout, Preparing reports, and publications required for product launch. I possess great skills in maintaining contact with study investigators to make sure that studies are opportune, performing internal performance testing, which includes, stability, proficiency, product development, reviewing cases with investigators to determine discrepancies, Study documents and to ensure the inspection condition. Represent the Clinical Documentation Center (formerly Document Management) in Studies teams. Contribution to departmental development through training and mentoring, as well as data management, audit and inspections, clinical trials overview, GCP - documents and Registration Authorities.

In addition to my extensive experience, I am highly proficient in computer skills, including Microsoft word, Outlook, MS office, MS project, power point, and excel. I have the ability to learn new software systems My communication abilities are not in doubt as I can achieve effective communication both written and orally. I can therefore speak and write simply, clearly and succinctly in English, German. My experience and skills coupled with my qualification and commitment to duties will be valuable to your organisation. With 4 years' experience as a Document Specialist and CRA, I am adept in file management, reporting, and document control. Moreover, while my on-the-job experience has afforded me a well-rounded skill set, including first-rate multi-tasking and prioritisation skills. I am competent in all my areas of research and studies and deem myself highly competent and qualified for this position. I can work and deliver the required result under pressure.

Also, I possess a solid educational foundation and passion fore efficient and accurate document control I am extremely enthusiastic about your company focus on updating file system and would welcome the opportunity to contribute to your continued success.

Please review my attached resume for additional details regarding my expertise and career achievements. I will follow up to request an appointment to discuss how my experience and background meet your needs.

Below is my LinkedIn link for details;

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MS office, SAP MM, EDL, eTMF, CRA