CLINICAL TRIAL MANAGER 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 recommende