Country Study Manager

5 days ago

Kuala Lumpur, Malaysia Icon plc Full time

**Overview**:
As a Country Study Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be part of an innovative and global Biotechnology company, who pride themselves to be one of the world's leading independent biotechnology companies. They focus on areas with unmet medical need with the ambition to help reduce the social and economic burden of disease in society today.

**Responsibilities**:
**What you will be doing**:

- Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
- Supports country-level operational planning and accountable for site selection within assigned countries.
- Contributes and develops to program/study-specific materials - e.g., monitoring plan, study specific training documents.
- Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
- Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers, Program Managers, CST or TMT, Development Operations Manager etc) with oversight as required and ensures updates to relevant systems.

**Qualifications**:
**You are**:

- Minimum 2-3 years’ clinical trial project management experience
- Minimum 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
- Experience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
- Must be a local/country expert with identifiable project management experience locally.
- Builds strong site relationships as well as other local relationships to ensure end to end study delivery is met.

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