Clinical Research Specialist

1 week ago

Kuala Lumpur, Malaysia Medtronic Full time

**Careers That Change Lives**

As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today. But we can’t do it alone. That’s why we’re committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.

Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 85,000 people worldwide, serving physicians, hospitals and patients in more than 160 countries. Join us in our commitment to take healthcare Further, Together.

**A Day in the Life**

**Clinical Research Specialist**:

- Represents clinical internally and externally for Emerging and Frontier Markets region based out of Malaysia.
- Manages the regional portfolio of physician-initiated research projects - External Research Program.
- Develops and executes clinical projects in the region for either a specific therapeutic area or across several therapeutic areas.
- Combines Clinical solution expertise and local market knowledge to drive local clinical execution and best healthcare solutions.

**Responsibilities**

**External Research Program (ERP) Management**:

- Build strong partnerships with global ERP team members and stakeholders, including: ERP board chair, ERP scientists, and evidence specialists from across the global businesses.
- Collaborate with global Medtronic regulatory, legal and compliance organizations to manage appropriate aspects of the portfolio.
- Establish and maintain communication with external researchers and internal stakeholders to ensure all required information is available for ongoing portfolio management.
- Ensure study files follow all applicable Medtronic policies and local regulations (including version-controlled protocols, legal agreements, consent documentation, regulatory approval documentation, etc.).
- Manage and maintain each project within the ERP tracking software (VisionTracker).
- Collaborate with Clinical IT to recommend enhancements and troubleshoot ERP tracking software.
- Create and process interim reports; review against contract to ensure payments can be requested; partner with Payments team to issue payments.
- Manage device allocation, distribution, and reconciliation.
- Adhere to Standard Operating Procedures (SOPs) and study management processes.
- Participate in and/or lead process improvement initiatives.
- Support the reporting of program metrics.

**Regional Clinical Affairs**:

- Represents Medtronic as “the Clinical face” within the country/region and acts at the same time as the “voice” of the local customers and authorities towards relevant stakeholders at Medtronic for the assigned therapeutic areas.
- Responsible for overall successful conduct of assigned global clinical studies consistent with applicable regulations, guidelines, and policies.
- Develops and execute regional clinical projects as Clinical Study Manager working with Operating Unit (OU) and global clinical teams.
- Establishes effective and systematic collaboration with relevant internal stakeholders (e.g. OU, Health Economic, Legal, RA stakeholders), physicians and hospitals and triggers the conversation locally around unmet clinical needs, outcome measurements and improving quality of care.
- Supports and provides input to the local clinical strategy and ensures full alignment with the global clinical strategy for each OU.
- Identifies potential local clinical studies in line with regional and OU strategies and submits potential study proposals to the clinical leadership for approval.
- Builds the right level of knowledge in reimbursement, health management in the country/region to address those with relevant clinical solutions.

**Be the first point of contact for**:

- Local OU stakeholders: to develop and execute regional projects addressing clinical needs
- Local customers, authorities and KOLs about local Clinical Affairs
- Clinical OU: for in-depth knowledge about the local clinical environment and for mandatory consultation on site nomination

**Local evidence dissemination & awareness**:

- Ensures awareness of local clinical activity and new clinical evidence and provides input to sales & marketing leaders
- Advises local marketing organization on outcome of publications and advises on a communication strategy
- Ensures strict adherence to regulations and communicates discrepancies to the different stakeholders
- Provides expert review of marketing/sales presentations, literature, and publications
- Provides clinical evidence dissemination to internal stakeholders
- If needed, provides clinical evidence for supporting tenders

**Must Have: Minimum Requirements**
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