Senior Associate I, TMF Operations - Europe - Home-based
at Worldwide Clinical Trials
București, Municipiul București, Romania -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 24 Jun, 2024 | Not Specified | 25 Mar, 2024 | 1 year(s) or above | Regulated Industry,Life Science | 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:
WHO WE ARE
Worldwide, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
YOUR EXPERIENCE
- University Degree preferred ( Life Science desirable )
- 1-3 years of relevant experience
- Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry
Responsibilities:
WHAT YOU WILL DO
- Perform RMC Lead Activities for 1-3 Studies.
- Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project. Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary.
- Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF.
- Oversee the QC process and makes sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly.
- Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors. Review TMF Key Performance Indicators (KPIs) and makes sure that TMF KPIs are in compliance.
- Support Regulatory and Sponsor audits and audits finding resolution, where necessary.
WHAT YOU WILL BRING TO THE ROLE
- Excellent written and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills
- Ability to handle multiple, highly detailed tasks with exceptional accuracy.
- Strong planning and organizational skills
- Proficiency in Microsoft Word and Excel
REQUIREMENT SUMMARY
Min:1.0Max:3.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
București, Romania
