About

I have experience in managing regulatory affairs including ensuring accuracy and completeness of study documents used. I have experience in translation and back translation of study documents into Luganda ensuring that meaning is not altered.

Skills

  • Regulatory affairs
  • Quality control and quality assurance
  •  Staff training and capacity building.
  • • Self motivated and target-oriented
  • Target Driven and Ethical Conduct
  • English
  • Luganda

Recommendations

10

"I recommend her for any organization she is always the best candidate when it comes to service delivery "

Experience

Winifred Zalwango

Work experience
  • Translation of required documents into the local language; Luganda.
  • Back translation of documents to ensure accuracy and completeness

Winifred Zalwango

Education

Winifred Zalwango

Work experience
  • Supervision of Quality Control Personnel.
  • Training of study staff on study protocol requirements.
  • Review and approval of study CRFs.
  • Version control of study documents.
  • Submission of studies to IRB and Regulatory bodies for approval.
  • Submission of studies to the IRB for renewal and progress monitoring.
  • Translation and back translation of study documents including Informed Consent forms and other study documents to Luganda.
  • Appraisal of study personnal and capacity building.
  • Tracking of the study master files.
  • Tracking of professional staff documentation.
  • Coordinatinating sponsor monitoring visits.

Winifred Zalwango

Work experience
  • Review of study tools.
  • Training of study personnel on study protocols.
  • Quality control levels 1 and 2.
  • Quality Assurance.
  • Formation and review of study CRFs.
  • Ensure staff compliance with study procedures.

Winifred Zalwango

Work experience
  • Informed Consent process.
  • Briefing of study participants.
  • Training of study participants on diary cards and other participant facing material.
  • Source documentation

Winifred Zalwango

Work experience
  • Arranging the Investigator Site file.
  • Educating participants on diary cards.
  • Traking of all standrad operating procedures for different studies.
  • Arranging visit Case report forms.

Winifred Zalwango

Education
  • October, 2017 - November, 2021
  • Fulltime

Related persons

10

"I recommend her for any organization she is always the best candidate when it comes to service delivery "