Careers in Clinical Trials

DID YOU KNOW?

A Clinical Trial Manager usually progresses in his/her career to senior management positions such as Associate Director or Director

MANAGING THE CLINICAL TRIAL

A Clinical Trial Manager is a key position in the management of clinical trials. A CTM should have good people management skills and the ability to anticipate problems and have back-up plans ready so that there is minimal impact on time, cost and quality of the project.

Next Commencement Date

01 OCT

2021

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Career as a Clinical Trial Manager

CLINICAL TRIAL MANAGER

A career as a Clinical Trial Manager is very challenging and demanding. A Clinical Trial Manager (CTM) has a significant role in the management of clinical trials and thus in the development of new treatments. A Clinical Trial Manager provides leadership in clinical trial activities and ensures that clinical trials are completed within budgets, in time and with the highest quality. A Clinical Trial Manager is responsible for managing the planning, implementation, and tracking of the clinical monitoring process, administration of clinical trials and maintaining an overview of ongoing clinical trials. A CTM acts as a guide to Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs). Often CRAs and CTAs working on a project directly report to the Clinical Trial Manager. A Clinical Trial Manager eventually gets promoted to Director and Senior Director levels.

Some common roles and responsibilities performed by the Clinical Trial Manager (CTM) are:

– Supervise in-house clinical trial staff
– Guide in the creation of important study documents
– Conduct feasibility studies
– Develop study budgets
– Oversee patient recruitment
– Ensure compliance of staff with the organizations Standard Operating Procedures
– Conduct team meetings and staff training programs
– Overall responsibility of the ongoing studies
– Participate in protocol development, CRF design and clinical study report writing
– Optimize costs and resources to help improve the organizations profitability

Competencies & Skills:

Various competencies and skills are required to become an efficient Clinical Trial Manager. Some of them are:

– Thorough understanding of the drug development process with extensive knowledge of ICH-GCP
– Extensive knowledge of clinical trial regulations such as those of US FDA, EMEA, DCGI etc
– Influential & assertive communication skills
– Excellent leadership skills
– Good record keeping skills
– Ability to motivate
– Self Confidence
– Ability to think Out-of-the-box
– Problem solving skills
– Conflict management skills
– People management skills

Education:

– Bachelors or Masters degree in Pharmacy or any Science related field is highly recommended

RECOMMENDED PROGRAM

To work as a Clinical Trial Manager (CTM) we suggest you consider the following online program(s):

Post Graduate Diploma in Clinical Research
Professional Diploma in Clinical Trial Management
– To increase the number of opportunities for you, you may also choose one of the Advanced Post Graduate Diploma Programs in Clinical Research based on your preferred specialization

Participant Feedback

"Thank you for the excellent sessions you conducted on Oracle Clinical. I thoroughly enjoyed the sessions and I am looking forward to more programs in future. Good luck to JLI."
Stephanie Rodriguez
Clinical Data Coordinator
Brazil


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