Clinical Research and Project Management Assistant

Clinical Research and Project Management Assistant

21729 Freiburg, Germany Req #46

Friday, November 8, 2024

Position Title: Clinical Research and Project Management Assistant

Location: Freiburg, Germany, or remote

Who we are:

TriNetX Oncology GmbH is a renowned vendor for a regulatory grade, fit-for-purpose oncology real-world data (RWD), and real-world-evidence (RWE) in Europe. By collecting representative, granular, and high-quality data we analyze the diversity of cancer care across the continent.

TriNetX Oncology regularly delivers comprehensive, in-depth insights to our valued clients and partners within the pharmaceutical industry by providing detailed, representative, and longitudinal analyses on epidemiology, patient profiles, disease characteristics, treatment algorithms, outcome assessments, and institutional attributes. These insights play a crucial role in facilitating external control arms, conducting adjusted comparison analyses, offering HTA support, generating business intelligence, and beyond.

What you will be doing:

You will work independently within a dynamic international team after the induction phase. We value collegial and open communication very highly. In doing so, you will primarily deal with the following main topics:

• Monitor and review clinical research data for accuracy, completeness, plausibility, and consistency
• Ensure compliance with study protocols and regulatory guidelines
• Identify and resolve data discrepancies or issues promptly
• Verifying the accuracy of all rules within the data capture system by entering test data
• Communicate with study sites and data managers to address data quality concerns
• Assist in the development and implementation of data quality assurance processes
• Support in generating reports and presentations on data monitoring activities for internal and external stakeholders
• Coordination of all monitors in consultation with the head of project management
• Manage site administration activities and maintain records
• Work in interdisciplinary teams such as (but not limited to) project management, data management, data operations, medical advisor, pharmacovigilance
• Support in training monitors (in conjunction with the PM and Medical Advisor)
• Support in setting up electronic questionnaires /documentation forms
• Management of participants in medical data collection surveys
• Assisting adherence to quality standards, project requirements, and compliance regulations throughout the project lifecycle
• Support in tasks related to other project management-related activities
• Support in process optimization and revision of SOPs and work instructions

Your Qualifications:

• Completed Bachelor's degree (preferably in natural science) or comparable other education in combination with work experience (e.g. CRA, medical documentalist)
• Experience working in clinical research, data management, or related field
• Strong attention to detail and analytical skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Knowledge of SecuTrial™ or other electronic data capture systems
• Very good knowledge of MS Office, especially in Word and Excel
• Knowledge of regulatory guidelines and Good Clinical Practice (GCP) standards
• You convince through very structured work and a high degree of initiative, as well as a solution-oriented approach
• You easily maintain a comprehensive understanding of project progress and status, with the ability to identify any potential issues or roadblocksTeam spirit, flexibility, and excellent communication required
• Ability to work in a changing and agile environment with international collaborations
• Very good written and spoken German and English skills

Preferred: Experience in oncology is of advantage but not a pre-requisite Language skills additional to German and English are beneficial but not essential

What we offer:

• A globally operating, multinational team of experts in a welcoming, communicative, and harmonious work environment.
• Specialization in transforming Oncology Real-World Data into Real-World Evidence, capitalizing on the current trend in the field.
• Exposure to, and collaboration in, advanced analytical methodologies, such as high-profile multivariate analyses, external control arms, and predictive and prognostic data modeling
• .Possibilities for personal and professional development on a global scale.
• Authorship in abstracts, manuscripts, papers, and posters, published at high-ranking medical congresses.
• 30 days of annual paid leave.
• A competitive incentive package.

Other details

• Pay Type Salary