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Clinical Research Manager
2 months ago
At ICON Strategic Solutions, we are seeking a highly skilled and experienced Bilingual Clinical Research Manager to join our team. As a Clinical Research Manager, you will be responsible for the end-to-end performance and project management of assigned protocols in a country, ensuring compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements.
Key Responsibilities:- Project management of assigned studies, including feasibility and site selection, recruitment, execution, and close-out.
- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Accountable for performance of assigned protocols in a country, ensuring compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required.
- Leads local study teams to high performance, trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert, and coordinates activities across the different local country roles ensuring a strong collaboration.
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF, and other key systems in assigned studies.
- Escalates as needed different challenges and issues to TA Head/CRD/CCQM and/or CTT (as appropriate).
- Identifies and shares best practices across clinical trials, countries, clusters.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Country POC for programmatically outsourced trials for assigned protocols.
- As a customer-facing role, this position will build business relationships and represent sponsor with investigators.
- Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
- Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH, and Regional Operations.
- Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
- 5-6 years of experience in clinical research.
- CRA experience preferred.
- Oncology experience required.
- Bachelor degree in Science (or comparable).
- Advanced degree, (e.g., Master degree, MD, PhD).
We are looking for a highly skilled and experienced Bilingual Clinical Research Manager to join our team. If you have a strong background in clinical research, excellent project management skills, and a proven track record of success, we encourage you to apply.
