Parexel Academy's newest offer to prepare you for a career in clinical research: online training delivered through our e-learning platform plus virtual encounters with Parexel experts from around the world. Drug Development, Regulatory Affairs, Clinical Monitoring, Data Management, Trial Management and Clinical Supplies.
About the program
NEXT PROGRAM START: 2021 - DATES TO BE DEFINED
The Virtual Postgraduate Certificate in Clinical Trial Management is a part-time program delivered fully online, being comprised of six modules:
- Drug Development
- Regulatory Affairs
- Clinical Monitoring
- Data Management
- Trial Management
- Clinical Supplies
The program is taught completely in English and offers participants both self-paced online learning and virtual encounters with Parexel trainers on specific dates, four times per module (one module per month).
The key features of this program are:
- Six months part-time
- Taught entirely in English
- Fully online learning
- Virtual instructor-led training sessions, which you attend online from your home or office on specific dates
- Fully virtual
- Online learning through reading, video presentations and exercises available at our e-learning platform
- Four virtual instructor-led trainings per module, where participants have the chance to interact with the trainers live through an online session or watch the recording if unable to join at a given time
- Virtual sessions of three hours each planned to take place every other week, twice a week (Thursday and Saturdays, 1PM-4PM Central European Time)
- Online learning to be done throughout the module, as preparation for the virtual encounters
- Monthly virtual sessions with the Program Management Staff to discuss administrative issues, ask for support and get insights about careers in Clinical Research and the basics of application coaching for jobs in the industry.
Who this program is for
- English speaking Life Science graduates, or IT, Statistics and Business graduates with relevant work experience
- Career movers interested in working in Clinical Research
- Professionals in the pharmaceutical industry wishing to deepen their knowledge of Clinical Research
- Recent graduates without work experience may apply
Application requirements and procedures
- Minimum Bachelor degree in Medicine, Nursing, Pharmacy, Life Sciences, or IT, Statistics or Business with relevant work experience.
- Fluency in English (equivalent to C1 level - no certification required if knowledge proved through studies or work experience).
- Application online: upload current CV and degree certificates (all in one file).
- After submitting the application, a telephone cross-check might take place in specific cases, to assess applicant's suitability to the program or language skills.
PLACES ARE LIMITED!
Funding possibilities in Germany
- There are a few government funding possibilities available for the participants of the Postgraduate Certificate in Clinical Trial Management:
- Living in Germany - To receive detailed information and find out which cases can be awarded funding, contact the Bundesministerium für Bildung und Forschung directly through the phone number 0800/2017909.
- Living and working in Berlin-Brandenburg - There is the possibility of applying for a Bildungsscheck in certain cases. Please note that apart from these government-funded options the program does not offer any sort of scholarship or private funding.
This module is about the discovery and selection of compounds for human diseases and the paradigm shift from random search to a rational approach. After completion of this module you will be able to:
- Describe the drug development process from drug discovery to market – past and pre-sent
- Understand the identification of drug targets based on a biochemical mechanism involved in a disease condition
- Understand chemistry, manufacturing and control (CMC)
- Describe preclinical testing to analyze the bioactivity, safety, and efficacy of the formulated drug product
- Understand Pharmacokinetic (PK) and ADME (Absorption/ Distribution/ Metabolism/ Ex-cretion) studies
- Understand human pharmacology studies in phase I clinical trials
- Describe phase II clinical trial designs and objectives
- Describe phase III clinical trial designs and objectives
- Understand objectives and strategies of post-marketing studies
- Apply patient centricity to the drug development process
- Understand the development process of cell & gene therapies
This module is about the legal framework, international guidelines, European requirements and national laws which govern the way in which Clinical Research is conducted. After completion of this module you will be able to:
- Understand the overall legal framework under which clinical research is currently conducted and what might change in the future
- Value the roles and responsibilities of key players in clinical research
- Outline the general process steps from the submission to the approval of a clinical trial
- Explain the importance of national laws within the commencement of a clinical trial
- Identify the purpose of essential documents in general and specific requirements for some of these documents
- Explain the patient information and consent process and apply the necessary explanations within this process in real examples
- Describe the basics of audits and inspections
- Evaluate common audit/inspection findings
This module is about the day-to-day practical work of a Clinical Research Associate (CRA), Safety Reporting requirements and standard trial documentation procedures. After completion of this module you will be able to:
- Describe the characteristics of standard documents of a clinical trial
- Explain the purpose of the different types of visits that are conducted by a clinical monitor
- Perform drug accountability, and to describe requirements for the handling of investigational drug
- Explain purpose and methods of source data verification
- Record issues and discrepancies in the required reports
- Identify issues and their impact, and to initiate appropriate actions
- Differentiate adverse events and serious adverse events
- Apply the concept of risk-based monitoring to on-site situations
This module is about the principles of clinical data management and the role of a Data Manager within Clinical Research. After completion of this module you will be able to:
- List and describe the main CDM processes from study start-up to database lock
- Describe the common technologies used to collect patient data
- Design and create CRFs (Case Report Forms)
- Explain how to setup a clinical database in regard to global data standards (CDASH)
- Provide the purpose of a DVP (Data Validation Plan) and to write edit checks
- Explain the different types of data entry and the quality control of data entry methods
- Write and process queries for data inconsistencies
- Classify protocol violations and to handle them from CDM perspective
- Describe why and how adverse events, diseases and therapies are being medically coded
- Explain when and how the clinical database is locked
- Identify the regulatory requirements that affect the processes for clinical data management
- Discuss challenges Clinical Data Management is facing in terms of risk-based monitoring, adaptive trial design, patient centricity, new clinical technologies (such as eCOA and wearables), and big data processing
This module is about the basic Project Management principles and fundamentals in the context of Clinical Research and the implementation of projects in a highly regulated environment. After completion of this module you will be able to:
- Apply key principles and core processes of Project Management to a variety of clinical trials
- Describe the life cycle of a typical clinical trial
- Name the relevant norms and standards regulating the implementation of project management
- Discuss requirements for risk-based management implementation to clinical trials
- Explain the impact of new technologies to early and ongoing project management processes
- Analyze risks and issues during clinical trials
This module is about the planning and execution of clinical trial materials management and logistics services in a clinical trial aligned with the global supply chain. After completion of this module you will be able to:
- Describe the life cycle of clinical supplies from manufacturing planning to final reconciliation
- Describe the various types of clinical supplies and laboratory samples
- Understand the regulations for IMPs (Investigational Medicinal Products), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Describe the role and tasks of the EU Qualified Person
- Understand biomarker and laboratory sample logistics and analytics
- Understand interactive randomization and inventory systems
- Develop a labelling/packaging/blinding/distribution strategy for clinical supplies
- Apply the concept of patient centricity and virtual trials to clinical supplies
- Understand new therapies e.g. cell & gene therapy and related clinical logistics
Info Session: Your career path in Clinical Research
Meet the Program Management Staff and enjoy a short virtual info session about career options in Clinical Research and how the Virtual Postgraduate Certificate in Clinical Trial Management can open doors to people interested in working in the area. Get detailed information about the program structure and registration procedures and have the chance to ask questions about the course and jobs in the industry
Module Leader for Drug Development and Clinical Supplies
Dr. Andrea Zobel
- PhD in Cancer and HIV Research
- Diploma in Biochemistry
- Extensive experience in Project, Product and Portfolio Management
- Expert in Clinical Trial Supply, laboratory Services and Logistics
- 15+ years experience in Clinical Research
- LinkedIn Profile
Module Leader for Regulatory Affairs
Consultant Academic Affairs
- Master's Degree in Pharmaceutical Sciences
- Licensed Pharmacist (Switzerland and Germany)
- 12 years experience as a Hospital Pharmacist
- 12+ years experience in Clinical Research
Module Leader for Clinical Monitoring
Manager Program Development
- State Registered Pediatric Nurse
- MSc in Medical Education
- 18 years monitoring experience in Germany, Switzerland, Austria, Belgium and Australia
- Clinical trial experience covers Phase II - Phase IV studies
- Therapeutic areas: oncology, internal medicine and pediatrics
- LinkedIn Profile
Module Leader for Data Management
Consultant Quality and Technology/Trainer Data Management
- State Registered Nurse (10 years experience, specialized in cardiology)
- Degree in Software Engineering
- 13 years experience as Clinical Data Analyst in Clinical Research (Phase II - III)
- 15 years experience in Clinical Research
Module Leader for Trial Management
Business Operations Associate
- 20+ years experience in a variety of industries and business ranging from NGO and internet start up to Clinical Research Industry
- Project Management Professional - PMP (PMI, Pennsylvania)
- B.A. Business Administration (GoBS Berlin)
- Project Management Economist (VWA Berlin)
Who should take part in the program and what are the requirements?
- The Virtual Postgraduate Certificate in Clinical Trial Management program is a part-time program aimed at working professionals who are graduates with a background in Life Sciences, Medicine and Nursing, or Information Science, Biostatistics and Business with relevant professional experience and do not have the possibility of joining live training at the Parexel Berlin facilities.
- Undergraduate, Master and PhD level qualifications in these disciplines are accepted.
- Applications from recent graduates are welcome.
- No previous work experience in Clinical Research or Clinical Trial Management is necessary.
How good do my English language skills really need to be?
All course materials are in English and the virtual instructor-led sessions are conducted in English.
To ensure that you enjoy your experience of the program to the fullest, and to ensure that you benefit from the input that program participants bring to the classroom, we recommend participants to have Level C1 English according to the Common European Framework of Reference for Languages or equivalent. If you do not have an English language certificate but have previously worked and/or studied in English that is fully accepted.
If you are not sure if your English level is sufficient to join the program, the Program Management staff will be able to assess that by the time a telephone cross-check is performed after you have submitted your application.
What are the registration procedures?
Eligible candidates are encouraged to submit an online registration via our website including:
- Updated Curriculum Vitae (max. 3 pages)
- Degree certificates
If you wish to submit multiple documents evidencing your academic achievements under the 'Degree certificates' upload function, simply join the documents together in a single PDF file and submit them that way.
After registering you will be taken to the confirmation page on our website, which means that your registration was successful. In case you are unsure about whether or not your documents were correctly uploaded, please contact the program management staff at firstname.lastname@example.org.
The Program Management staff will check the submitted documents and assess if you fit the acceptance criteria. Once this verification is completed, they will contact you via email to arrange a quick phone call to discuss the next steps of you enrollment in the course and give you the chance to ask questions about the program. In case the candidate is unable to join via telephone, a conversation via email would also be possible.
After liaising with the candidates and assuring that they fit the requirement and would like to join the program, the Parexel Academy will issue a course participation contract to be signed by both parties. This binding document completes your enrollment in the program.
Why was this program established?
The Virtual Postgraduate Certificate in Clinical Trial Management is a derivation from the Parexel Academy's Postgraduate Certificate in Clinical Trial Management, a blended learning program developed as a bridge between science and industry focused on participants based in Europe, who are able to travel to Berlin to attend regular live sessions. As the number of applications from outside Europe increased throughout the years, the Academy decided to adapt and adjust the original blended learning program to a full virtual format, giving participants from other continents a chance to join the training. Similarly to its 'sister' program, the Virtual Postgraduate provides working professionals with exclusive industry insights and a solid academic foundation in the field of Clinical Trial Management.
How is the program taught?
The program is made up of 6 modules including
- Drug Development
- Regulatory Affairs
- Clinical Monitoring
- Data Management
- Trial Management
- Clinical Supplies
The modules are taught in part-time format over the course of 6 months (one module per month). Students will complete online components before getting connected online for each virtual instructor-led training sessions, which are scheduled to take place on specific dates, four times per module (two sessions every other week).
Can I continue working in my current job during the program?
Yes. During the program students are provided with recorded presentations and tasks to complete at our e-learning platform, which can be reviewed and completed according to your personal schedule within the learning weeks assigned (i.e. before the virtual instructor-led sessions). The workload (hours needed for completion) is estimated at 20 hours per module, plus four virtual instructor-led sessions of three hours each in each module.
Please refer to the program calendar for further details.
How much of my time should I calculate to complete each module (workload)?
Approximately 20 hours should be set aside for completing the online activities planned for each module and available at our e-learning platform. Furthermore, each module counts with four virtual instructor-led sessions, consisting of three hours each and occurring every other week, twice a week.
Please view the program calendar for exact dates.
Do I have to be connected at specific times to take part in the program? How does the e-learning work?
Yes. During the program students are provided with two types of e-learning:
- Self-paced readings, recorded presentations and videos, which are available at our e-learning platform and can be reviewed and completed according to your personal schedule within the learning weeks assigned (i.e. before the virtual instructor-led sessions).
- Virtual instructor-led training sessions, which are video-conference encounters with the trainer and other participants and are hosted at a different platform. These sessions have a set date and time to take place and participants should take that into consideration when planning their participation in the program. In case a session is missed, or that due to time difference the session takes place at unacceptable times in your region, a recording will be available after each training for you to complete your learning.
Who will teach me? Are the trainers available to answer questions?
Your trainers are senior industry specialists from Parexel International or other CROs and they will be available to answer your questions via email or during the video-conference encounters.
How many students are enrolled in each program?
The program has a maximum of 20 participants per course. Parexel Academy will only commence with a program once 8 successful applicants have enrolled.
How do I pay the program tuition fees?
The tuition fees can be paid in a single payment or divided into six equal installments (to be paid monthly).
You will receive an electronic invoice shortly before the program starts. If you decide to pay in installments, you will receive one electronic invoice with due dates for each of the six installments.
Is funding available for the program? Are there any scholarships?
Unlike the intensive, full-time Weiterbildung in Clinical Trial Management program, funding is not available from the German Federal Employment Agency. There are no scholarships available to cover or reduce the costs of tuition. Participants are expected to cover the costs of tuition independently.
How can I get practical skills or training during the program? Are there opportunities for internships?
The part-time Virtual Postgraduate Certificate in Clinical Trial Management is conceived for those currently working in professional roles but looking to enter the field of Clinical Research. Given the depth of commitment necessary to meet the objectives of the program alongside the requirements of a profession, it is not planned for participants to undertake practical experience during the program.
Are the learning outcomes of this program transferable? Will I be able to find a job at Parexel after completing the program?
The Virtual Postgraduate Certificate in Clinical Trial Management provides graduates with a thorough understanding of clinical trials. The six-module format will produce learning outcomes that address core competencies in Clinical Research. Once put into practice they will form the basis of transferable skills and valuable knowledge for use in a role in the Clinical Research industry.
We cannot guarantee a job at Parexel upon completion of the program. However, we are confident that graduates will be competitive when applying for entry level roles in Clinical Research. Our program bridges the gap between totally inexperienced job seekers and experienced staff, who simply do not exist in sufficient quantities. In a rapidly expanding job market, this gives Parexel Academy graduates a significant advantage over candidates with no relevant knowledge or qualifications.
Which certification do I receive if I join the program?
After program completion (including the 6 modules) participants will receive a postgraduate certificate issued by the Parexel Academy. Please have in mind this is not an academic certificate, although it is highly regarded within the pharmaceutical industry.