tenbosch

● Clinical Project Management

● Regulatory Submissions

● Ethics Submissions

● Study Site Management

Your are looking for support in the execution of clinical studies?

Need a thorough approach to regulatory and ethics submissions?

Looking for practical advice or implementation support for your clinical studies? Our expertise spans all phases, ensuring quality every step of the way.

You value the professionalism, efficiency and confidentiality offered by a Clinical Research Professional with many years of experience?

We offer dynamic, flexible freelance solutions tailored to your unique needs in both national and international Phase I-IV clinical trials.

From project management to trial site oversight, we prioritize efficient, results-oriented service.

We are dedicated to delivering comprehensive services as flexible freelancers, encompassing all formal requirements of clinical trials. Our extensive experience with pharmaceutical companies and clinical trial sites across Germany and internationally ensures that your research is in capable hands.

Dr. phil. nat. Jochen Tenbosch (PhD)

CURRICULUM VITAE

Education

2000: PhD degree

Work History

2001 – 2006 (and intermittend ongoing) : CRA, Lead CRA, Global Lead CRA (Freelancer), Phases I-IV
2007 – 2008: Global Clinical Project Manager Headquarter Pharmaceutical Industry
2009 – ongoing: Clinical Project Management (Freelancer), Phases I-IV
2016 – ongoing: Regulatory Affairs Manager (Freelancer)
2018 – ongoing: Clinical Study Start-Up Manager (Freelancer)

Expertise in Therapeutic Areas

Oncology
Hematologic Disorders: Comprehensive experience in managing clinical trials for chronic myeloid leukemia (CML), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and multiple myeloma, covering all Phases I-IV
Solid Tumors: Proficient in trials related to gastrointestinal stromal tumors (GIST), acromegaly, prostate cancer, glioblastoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), melanoma, and conditions related to iron overload, such as Thalassemia major, Thalassemia intermedia, and rare anemias
Infectious Disease: Focused experience in Hepatitis C (Phase I) and Influenza (Phase III) clinical trials, contributing to advancements in treatment and understanding of these conditions
Neurology CNS: In-depth involvement in studies targeting Parkinson’s Disease and Alzheimer’s Disease, aimed at exploring innovative therapies and improving patient outcomes
Organ transplantation: Specialized in kidney transplantation studies, including both adult and pediatric populations, addressing critical aspects of organ acceptance and patient care
Respiratory Conditions: Works in the field of Asthma bronchiale aiming to enhance therapeutic strategies and patient quality of life

Languages

German (mother tongue)
English (fluently)

Computer Proficiency in Clinical Research

Broad Software Knowledge: Versatile familiarity with a wide range of software applications, with a specialized focus on clinical research tools
Clinical Trial Management Systems (CTMS): Proficient in leading CTMS platforms including IMPACT, SPECTRUM, Veeva Vault, and Oracle’s eClinical, alongside InfoLink2, enhancing efficiency in trial
Electronic Data Capture (EDC) Systems): Skilled in the utilization of various EDC systems, ensuring accurate and secure data collection. Notable platforms include Medidata RAVE, INFORM, and OpenClinica
Microsoft Office Suite: Advanced expertise in all versions of Microsoft Office, including Word, Excel, PowerPoint, and Access, facilitating effective data analysis, report creation, and presentations