AddressRequired 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 DESCRIPTION
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The position manages all aspects of clinical trial operations in a country and will manage exquisite execution of all interventional clinical trials as well as oversight of Local Clinical Evaluations (LCEs) of an interventional nature and CRO run studies. Will adhere to Good Clinical Practices (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies. The position will manage the trial quality, audit responses and the completion of Corrective Action and Preventive Action (CAPAs).
The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across all phases within the country. The position has multiple touchpoints with Global Clinical Trial Operations (GCTO) and company Research Labs staff in our headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a highly matrix-based organization. There are some interfaces with Human Health/Global Medical Affairs (GMA).
EXPERIENCE:
- Minimum 10 years in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
EDUCATIONAL QUALIFICATIONS:
- Required: Bachelor’s degree in life sciences combined with consistent contribution to and delivery of clinical trial execution.
- Highly Preferred: Advanced degree (e.g. MA/MS, MD, PhD, Pharm D).
TRAVEL REQUIREMENTS:
25%
Responsibilities:
Current Employees apply HERE
Current Contingent Workers apply HERE
