Clinical Operations Manager

2 days ago

กรงเทพมหานคร, Thailand MSD Full time

**Job Description**:
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

**WHAT YOU WILL DO**

**Key Responsibilities**:

- Executes and oversees clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines, and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
- Contributes to the development of local SOPs. Oversees CTCs as applicable.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
- Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
- Ownership of country and site budgets. Development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.

**WHAT YOU MUST HAVE**

**To be successful in this role, you will have strong technical skills as well as business capabilities. The requirements are as follows**:

- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
- Expertise of core clinical systems, tools, and metrics
- Excellent English skills
- Requires strong coordination and organizational skills
- Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups.
- Requires ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal support from manager.
- Requires ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
- Requires the ability to pro-actively identify issues and risks, analyses root cause, and propose solutions to problems and escalate to management as applicable.
- Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
- Ability to focus on multiple deliverable and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
*

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