Clinical Trial Assistant at Drugs for Neglected Diseases initiative - DNDi

Job description

Purpose of the position

The Clinical Trial Assistant will offer the much-needed assistance to clinical trial teams including visceral leishmaniasis, mycetoma, and paediatric HIV in the course of the studies. S/he will mainly be concerned with management of the Trial Master File (TMF).

Specific job responsibilities

• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of Trial Master file (TMF) for completeness.
• Assist clinical trial team in ethics and regulatory submissions.
• Assist clinical team with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
• Handle any other tasks as assigned
• Participate in efforts geared towards improving the effectiveness and efficiency of operations in accordance with the policies and procedures as laid down in the organization’s Quality Manual

Job requirements

Skills and attributes

• Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
• Very good communication skills in multicultural, multi-lingual environments
• Ability to work effectively as part of a multicultural team
• Well organized and structured
• Very good analytical skills
• Ability to contribute to the project delivery under minimum supervision
• Ability to manage small projects if delegated by upper levels with supervision

Experience

• Minimum of 3 years’ experience in clinical trials
• Proven ability to work effectively in a team environment and matrix structure
• Experience working with investigator site files/TMF/Regulatory submissions is desirable

Education

• Diploma/Degree in health-related field.
• Knowledge of GCP/ICH