key Responsibilities

Performance: Accountable for performance and compliance for assigned protocols in accordance with ICH/GCP and country regulations, as well as client policies and quality standards.
(30%)
Management: Serve as the point of contact for assigned protocols, proactively driving execution and performance to meet country commitments. Collaborate closely with local CO roles and forecast resource needs.
(20%)
Quality Oversight: Ensure quality and compliance in assigned protocols. Oversee CRAs and CTCs, ensuring training compliance and conducting quality control visits. Review monitoring reports and escalate issues as needed.
(20%)
External Customer Facing: Collaborate with functional outsourcing vendors, investigators, and external partners. Oversee site validations, selection, and recruitment, providing education about clinical trials.
(20%)
Internal Collaboration & Strategy: Work with local Pharmacovigilance, Regulatory Affairs, and Global Medical Affairs to support strategy development consistent with corporate needs.
(10%)
Additional Duties: Perform all other duties as assigned.

Qualifications

University/college degree in a life science field preferred, or certification in a related health profession (nursing, medical, laboratory technology).
Minimum of four (4) years of relevant clinical research experience in pharmaceutical or CRO industries, or equivalent experience in a healthcare setting may be considered.
Thorough knowledge of ICH Guidelines and GCP, with an understanding of regulatory requirements in various countries.
Strong understanding of the drug development process.
Fluent in the local office language and in English, both written and verbal.

Local Study Manager