Job: Clinical Trial Manager

1) Lead external pivotal clinical studies throughout all stages of including design, implementation, monitoring and closeout
2) Serve as primary clinical contact for pivotal studies
3) Lead start-up, ongoing activities, close-out and reporting of specific clinical trials and research projects, both in-house and external clinical studies
4) Author external clinical protocols, informed consents and training materials for assigned studies
5) Negotiate budgets and contracts including clinical sites, vendors, and contract laboratory (ies)
6) Serve as the primary contact with external investigators and site staff for assigned external studies
7) Conduct laboratory assessments as required
8) Provide training for laboratory assessments to others
9) Manage site initiation of assigned studies including review of study requirements, GCP, GDP, AE/SAE with site staff and investigator
10) Monitor as per study needs
11) Write monitoring report and mediate all issues with site personnel
12) Ensure clinical inventory are available, distributed, used, document and reconciled accurately
13) Track and maintain enrollment at sites weekly
14) Review data entered into EDC system
15) Work with Data Management and Statistics
16) Generate interim and final report

Critical Requirements:

1) A university degree is required (preference will be given to those with degrees in a relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the health care industry is strongly preferred
4) Preference will be given to people with recent experience in clinical management

If you think you're a perfect match for this role, you could be just the person to fill the position. Please apply ASAP.