Clinical Trial Coordinator
vor 1 Woche
Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
We are continually striving to improve the understanding of health care within the local community.Our site in 1100 Vienna (ICON Tower) is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients.
To ensure sustainable company growth, we continually aim to offer attractive career opportunities for more than 170 employees at our Vienna site.
_ Clinical Trial Coordinator (M/F/d)_:
As a Clinical Trial Coordinator you are responsible for comprehensive trial and site administration in Austria. The person prepares, collates, distributes and archives clinical documents and ensures timely maintenance of tracking and reporting tools. The role is critical to meet planned Site Ready dates.
The CTC is collaborating at local level closely with the country operations manager (COM), the project manager (CRM) and the clinical research associate (CRA).
Furthermore, the CTC is managing payments according to contracts with clinical trial sites.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation.
Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
Responsibilities
Trial and site administration:
- Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
- Ensuring collation and distribution of study documents
- Updating databases and trackers
Document management:
- Preparing documents and correspondence
- Collating, distributing and archiving clinical documents
- Preparing Investigator trial file binders
Regulatory & Site Start-Up responsibilities, in collaboration with country:
- Providing to and collecting from investigators documents for site start-up and submissions
- Obtaining, tracking and updating study insurance certificates
- Supporting preparation documents for EU CTR submission
Budgeting, Agreement and Payments,
in collaboration with finance/budgeting representatives:
- Calculating and executing payments to investigators
- Controlling trial site payments against budget, tracking payments from site setup until closeout
- Maintaining tracking tools
Qualifications
- Completed job training (office management, administration, finance, health care preferred) or Bachelor's Degree
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
- Hands on knowledge of Good Documentation Practices
- ICH-GCP Knowledge appropriate to role
- Effective time management, organizational and interpersonal skills, conflict management
- Ability to set priorities and handle multiple tasks simultaneously in a changing environment
- Works effectively in a matrix multicultural environment
- Able to work independently
- Excellent communication skills
- Proactive attitude to solving problems / proposing solutions
- Excellent verbal and written communication skills in German and English
We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Secondary Language(s) Job Description**:
NA
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
07/2/2024
Job Posting End Date:
07/02/2024
Requisition ID:
R292370
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