12 ago
|
Syneos Health
|
Tlalnepantla de Baz
12 ago
Syneos Health
Tlalnepantla de Baz
Clinical Trial Manager - Future Roles (Mexico)
Updated: Today
Location: Tlalnepantla, MEX, Mexico
Job ID: 25107138
Clinical Trial Manager - Future Roles (Mexico)
We are a leading biopharmaceutical solutions organization dedicated to accelerating customer success by translating unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job Responsibilities
- Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely), ensuring regulatory, ICH‑GCP, and Good Pharmacoepidemiological Practices (GPP) compliance.
- Assess site and site staff performance, recommend site‑specific actions, and develop action plans with guidance.
- Verify informed consent procedures, protect subject confidentiality, and assess factors affecting patient safety and data integrity.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assess site processes.
- Conduct source document review of site source documents and medical records.
- Verify required clinical data entered in the case report form (CRF) is accurate and complete.
- Apply query resolution techniques remotely and on site, driving resolution to closure within agreed timelines.
- Utilize available hardware and software to support clinical project data review and capture.
- Verify site compliance with electronic data capture requirements.
- Perform investigational product (IP) inventory, reconciliation and reviews of storage and security; verify IP dispensation and administration; address blinded or randomized IP issues.
- Review the Investigator Site File (ISF) for accuracy, timeliness and completeness; reconcile with the Trial Master File (TMF).
- Document activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents per SOPs; support subject recruitment and retention.
- Manage site‑level activities, budgets and timelines; ada
📌 Clinical Trial Manager (Tlalnepantla de Baz)
🏢 Syneos Health
📍 Tlalnepantla de Baz