Local Study Manager
at TFS HealthScience
02-390 Warszawa, województwo mazowieckie, Poland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 22 Apr, 2025 | Not Specified | 23 Jan, 2025 | N/A | Clinical Trials,Regulatory Requirements | 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:
QUALIFICATIONS
- Degree in medical, biological sciences, or a related field.
- Experience in clinical trials and study management.
- Strong leadership and problem-solving skills.
- Excellent knowledge of ICH-GCP and regulatory requirements.
- Effective communication and team management abilities.
A BIT MORE ABOUT US
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in decision-making and help attract talent who share these principles. Together, we innovate and excel, fostering a culture of respect and collaboration to make a difference
Responsibilities:
ABOUT THIS ROLE
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Local Study Manager (LSM) is responsible for ensuring the successful delivery of clinical studies within assigned countries, maintaining compliance with industry standards, regulations, and timelines while leading the local study team.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company that is an industry leader in innovative therapies.
KEY RESPONSIBILITIES
- Lead local study teams, ensuring study timelines, quality, and regulatory compliance.
- Develop and implement monitoring plans; perform co-monitoring and quality control visits.
- Manage site selection, investigator meetings, and patient recruitment strategies.
- Maintain Trial Master Files and prepare studies for audits and inspections.
- Oversee study budgets, payments, and resource allocation.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
02-390 Warszawa, Poland