Regulatory Submissions (Study Start-up) Manager
at Medpace Inc
SYV3, Victoria, Australia -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 21 Sep, 2024 | Not Specified | 22 Jun, 2024 | 5 year(s) or above | Communication Skills,Clinical Research | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Job Summary :
We are currently seeking a full-time Study Start Up Submissions Manager to join our Clinical Operations team in Melbourne, Australia.
Responsibilities :
- Efficiently manage and successfully execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits.
Qualifications :
- More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Regional experience will be highly advantageous;
- Strong oral and written communication skills.
Responsibilities:
- Efficiently manage and successfully execute all aspects of global start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits
REQUIREMENT SUMMARY
Min:5.0Max:10.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
South Yarra VIC 3141, Australia