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 programThe 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
- 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
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.
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.
Drug DevelopmentThis 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 in-volved in a disease condition
- Understand chemistry, manufacturing and control (CMC)
- Describe preclinical testing to analyze the bioactivity, safety, and efficacy of the formu-lated 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
Regulatory AffairsThis 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
- Promote excellence in your knowledge in German (drug) laws
- Outline and compare submission – approval steps from different countries
- Gain tips and knowledge on the authorization of clinical trials
- Understand newer therapeutic concepts (decentralized trials, ATMPs) and (lack of) corresponding regulations
- Identify the importance of essential documents
- Apply the necessary explanations in informed consent process by reviewing given documents
Clinical MonitoringThis 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:
- 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
- Implement patient centricity into site management activities
Data ManagementThis 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 understand:
- How to set the entire process of CDM tasks in the Data Management Plan
- How to design and create Case Report Forms (CRF) for collecting study data and how to write the corresponding CRF completion instructions
- How to set up a database with regards to global data standards (CDISC/CDASH) and set the associated data validation checks
- How the patient data is entered
- How queries for inconsistent/non-compliant data are generated and processed
- How to find and handle protocol violations from CDM perspective
- How diseases and medicines are medically coded in order to be classified
- How the database is locked at the end to prevent future changes to the data
Trial ManagementThis 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
- Explain what needs to be considered during the early stages of clinical trials
- Evaluate budgets, contracts and resources from the management perspective
- Discuss requirements for risk based management implementation to clinical trials
- Apply quality management principles to clinical trials
- Assess expectation in vendor and client management activities
- Analyze risks and issues during clinical trials
Clinical SuppliesThis 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)
- Understand the principles of Good Manufacturing Practise and Good Distribution Practice
- Describe the quality management and documentation of clinical supplies
- Describe the role and tasks of the EU Qualified Person
- Calculate clinical supply demand and plan manufacturing
- Understand forecasting and simulation tools
- Understand randomization and blinding of clinical supplies
- Understand interactive randomization and inventory systems
- Develop a labelling/packaging 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
Webinar: Your career path in Clinical Research
Meet the Program Management Staff and enjoy a short webinar 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 application procedures and have the chance to ask questions about the course and jobs in the industry
Dates and registration
Module Leader for Drug Development and Clinical SuppliesDr. Andrea ZobelSenior DirectorParexel Academy
- 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 AffairsBettina Merz-NideroestConsultant Academic AffairsParexel Academy
- 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 MonitoringClaudia RichterManager Program DevelopmentParexel Academy
- 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 ManagementBirgitt WöhrleConsultant Quality and Technology/Trainer Data ManagementParexel Academy
- 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 ManagementCaroline BrassBusiness Operations AssociateParexel Academy
- 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, IT, Biostatistics of Business 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 ask that your English be certified to Level C1 according to the Common European Framework of Reference for Languages or equivalent.If you are not sure if your English level is sufficient to join the program, please get in contact with the Program Management staff to discuss the issue.
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. An online assessment to confirm that you have completed this part of each module will need to be completed within certain deadlines. 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.
Will I get a job at Parexel upon completion of the program?There is no guarantee of subsequent employment at Parexel. However, the Program Management staff is committed to ensuring that your visibility as a candidate is at its highest.
What are the application procedures?
Eligible candidates are encouraged to submit an online application 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 submitting your application you will be taken to the confirmation page on our website, which means that your application 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.
Our Selection Panel will discuss the applications received and invite candidates with a matching profile to a telephone interview.
There is no need to participate in an assessment center to take part in the program. Our Selection Panel will assess your suitability based on the strength of the documentation you submit. You will be informed of the success of your application shortly after the phone interview has been conducted.
Why was this program established?The Virtual Postgraduate Certificate in Clinical Trial Management was developed as a bridge between science and industry, focusing on participants who are not based in Europe or Germany specifically. The increasing growth in the field of Clinical Research and Contract Research Organizations make this an exciting industry. This program 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
- Clinical Data Management
- Trial Management
- Clinical Trial 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).
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.
Who will teach me?
Your trainers are senior industry specialists from Parexel International or other CROs.
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.
Is funding available for the program?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 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.
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.