Parexel Academy's Virtual Posgraduate Certificate in Clinical Trial Management prepares you for a career in clinical research: online training delivered through our 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: 17-MAY-2021 - APPLICATIONS OPEN NOW
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
- Professional Skills
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 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
- 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.
- Fluency in English.
- Submission of CV and degree certificates via email
- 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.
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
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 email@example.com.
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.
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 transferrable 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.
Are any scholarships available to undertake the Postgraduate Certificate in Clinical Trial Management?
We offer participants the opportunity to pay the tuition fees in monthly installments. Apart from this special arrangement, there is no opportunity for alternative tuition fee reductions or scholarships.