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