Local Trial Manager
at IQVIA
Home Based, KwaZulu-Natal, South Africa -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Jan, 2025 | Not Specified | 26 Oct, 2024 | N/A | Patient Outcomes,Population Health,Communication Skills,Commercialization,Regulations,English,Trial Management | 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:
SERVICES OVERVIEW:
Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Site Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- BA/BS degree.
- Degree in a health or science related field.
- 2 years of local trial management or mutually agreed clinical trial experience.
- o Advanced: 3 to 5+ years of trial management experience.
SPECIFIC THERAPEUTIC AREA EXPERIENCE MAY BE REQUIRED DEPENDING ON THE POSITION.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
- Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.co
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Home Based, South Africa