BPS - Bio Pharmaceutical Solutions

Careers in the Pharmaceutical and Biotechnology Industry - Clinical Research
 
Drug development has been around for hundreds of years in a variety of forms. Whether it is from the early experiments conducted by James Lind in the 1700's to more modern day clinical research, it has evolved to into a highly regulated, complex and expensive industry. Clinical research is a broad description, but it encompasses the identification of new chemical entities or devices, animal studies, human clinical trials and post marketing surveillance. The development pathway can take approximately 15 years and during this time, many functional areas play a role in gathering the data for registration and ongoing marketing of a product.
 
These areas include:
  • Pre-clinical development
  • Clinical Production
  • Product Development
  • Clinical Research
  • Regulatory Affairs
  • Pharmacovigilance
  • Biostatistics
  • Scientific Affairs
  • Medical Writing
Although all the above can play a role in the product development process this article will specifically focus on the functional area of Clinical Research and the possible career paths available in the Pharmaceutical, Contract Research Organisation (CRO), Biotechnology and Hospital environment.
Most companies, whether they are large global companies or smaller local organisations, have a structure that recognises the individual's skills set, experience, which incorporates a career pathway.
 
Clinical Career Pathway Diagram
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1 Clinical Research Career Pathways
 
Entry Level - Adminstration and Clinical Trials Assistant
Administration or Clinical Trial Assistant (CTA) roles are considered the most junior to the industry. Usually operating in-house, their key function is to provide administration support to the operational staff. Some companies seek employees for whom this role is as a chosen career, other companies use it as a training role for the development of Clinical Research Associates (CRA).
 
Key Functions:
  • Set up and maintain the Investigator files
  • Track ing of essential documents
  • Assist with the compilation of Institution Ethics Committe (IEC) / Institution Review Board (IRB) documentation
  • Assist with co-ordination and event management such as Investigator meetings, Initiation Routine Monitoring and Close-out visits
  • Assist with tracking of Case Report Forms (CRFs)and Data Queries
  • Provide and track the distribution of supplies to investigational sites
  • Participate in co-monitoring visits under the assistance of CRA where applicable
Qualifications:
The qualifications for these roles may vary from company to the company and they may range from no formal requirement to a Pharmacy, Medical, Science or related degree.
 
Experience:
The experience required for the role could include none, to several years relevant industry.
 
Alternative Titles:
  • Clinical Administration
  • Clinical Support
Further information on how to enter the industry can be found at /9536150/bps-format-testing-on-roles-in-industry.htm
 
Operational - Clinical Research Associate and Senior Clinical Research Associate
The roles of a CRA or SCRA are key to the successful management of clinical trials. You may have responsibility for a number of studies at various phases of development and across different therapeutic areas, depending on the needs of the company. These factors will influence the number of clinical sites you are responsible for but it is not unusual for a CRA or SCRA to be responsible for 8-12 sites over a large geographical area.
 
On a daily basis you will required to answer queries such as:
1. Technical questions related to the protocol e.g. Interpretation of the inclusion or exclusion criteria
2. Process related questions e.g. How to prepare the investigational product for use
3. Good Clinical Practice questions e.g. How to document an Adverse Event correctly in the Case Report Form.
 
These queries can be raised by Investigators, Study Co-ordinators, the trial Pharmacist or even internally by other study team members.
 
Most companies have well-established Standard Operating Procedures (SOPs) and essential documents such as the Protocol available, to support your day to day activities. However, the depth of your involvement in these types of activities will be dependant upon whether you are operating out of a Head Office or Global subsidiary.
 
The ability to travel frequently both domestically and internationally is essential to the role.
 
Key Functions:
  • Identifying and selecting clinical trial sites
  • Negotiating and drafting Clinical Budgets and Agreements
  • Preparing and submitting IEC/IRB applications
  • Conducting Site Initiation meetings
  • Monitoring patient recruitment
  • Managing contract staff such CROs, laboratory etc
  • Conducting Routine Monitoring
  • Conducting study Close Out visits
  • Drafting and reviewing essential documents
  • Compliing to the companies SOP and ICH GCP for the reporting of Serious Adverse Events
  • Audit preparation
  • Relationship building with internal and external stakeholders such as Regulatory affairs, Pharmacovigiliance, Project Management, investigators, study co-ordinators, pharmacists etc.
Qualifications
Most companies require a minimum of Bachelor degree in Nursing, Life Sciences or a related field. Additional postgraduate qualifications are held in high regard.
 
Experience
More senior roles require additional demonstarted experience. (At least 12-18 months).
 
Alternative titles
  • Clinical Co-ordinator
  • Clinical Site Monitor
  • Clinical Study Manager
Management - Clincal Project Manager and Clinical Research Manager
After several years of working in Clinical Research there may be an opportunity to progress your career towards a management role. This role may be aligned with a therapeutic area, eg. oversight of the Oncology portfolio, or it may be a role where you manage a team of clinical research professionals working across different therapeutic areas. These roles require demonstrated line management and leadership skills.
 
Key Functions
  • Support and manage staff through out the clinical trial process
  • Provide guidance on the implementation of company SOPs and Regulatory guidelines
  • Formulate and oversee the Clinical Development Program budget
  • Provide input where required into both national and international strategic operations
  • Undertake a regular review your teams individual performance against agreed Key Performance Indicators
  • Assist with developing and appraising Personal Development Plans for the members of your team
  • Develop and supervise operational compliance with the project plans including recruitment targets, monitoring plans etc
  • Provide strategic input to development plans for the company
  • Assist with Data Safety Monitoring Review Board co-ordination
  • Provide updates to the clinical team on amendments to SOPs or relevant regulations
  • Manage strategic relationship with external vendors such as CROs
  • Identify and implement efficiencies ensuring industry best practice in the clinical department
  • Build and maintain relationships with Key Opinion Leaders and other influential parties
Qualifications
Most companies require a minimum of Bachelor degree in Nursing, Life Sciences or a related field with additional postgraduate qualifications such as a Masters in Business Administration or PhD.
 
Experience
It is generally considered that a minimum of 5 years experience including direct line management is required to fulfill a management role.
 
Alternative titles
  • Clinical Program Manager
  • Head of Clinical Research

For further information please contact the team at Bio Pharmaceutical Solutions at info@biops.com.au or on 1300 232 849.