เอ็มเอสดี (ประเทศไทย) จำกัด
Study Start-Up Specialist (COM or aCOM-I/II)
ที่เอ็มเอสดี (ประเทศไทย) จำกัด
Job Description
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality, standards and adverse event reporting requirements internally and externally.
Under the oversight of the Sr.COM/COM Lead, the person is responsible for execution and oversight of clinical trial country submissions and approvals.
Responsibilities include, but are not limited to:
- Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations.
- Interact 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.
- Coordinates and liaises with CRM, CTC, CRA, other functions areas to ensure country
- Support of local regulatory and financial compliance. Ability to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
- 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.
- 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 systems.
- Provide support and oversight to local vendors as applicable.
- Contributes to the development of local SOPs.
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
- Contributes strongly to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Contributes to COM team knowledge by sharing best practices appropriate/required.
- May act as buddy / mentor.
- Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.
- Knowledge of core clinical systems, tools and metrics
- Excellent verbal and written skills, in local language and English
- Strong coordination and organizational skills
- Knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
- Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.
- Ability to make decisions independently with oversight from Line Manager.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. ICH/GCP knowledge appropriate to role. Good knowledge of Good Documentation Practices
- Able to work with other experienced clinical research professionals and manage select protocols independently. Works with high quality and compliance mindset.
- Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, contribute to root cause analysis, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
- Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.
- High sense of accountability and urgency in order to properly prioritize deliverables
- Strong communication and negotiation skills as well as developing skills in influencing and training/mentoring, both written and verbal, in local language and English.
- Ability to focus on multiple deliverables 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.
- Positive mindset, growth mindset, capable of working independently and being self-driven
- Able to directly influence site staff
Qualification & Experience:
- 2-5 years of experience in Clinical Research
- Preferred: Bachelor's degree
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R285995
ทักษะที่จำเป็น
- Compliance
- Finance
- Legal
- English (Excellent)
ประสบการณ์ที่จำเป็น
- 2 ปี
ทักษะเพิ่มเติม
- Contracts
- Negotiation
- Risk Management
เงินเดือน
- สามารถต่อรองได้
สายงาน
- บริหารผลิตภัณฑ์ / บริหารแบรนด์สินค้า
ประเภทงาน
- งานประจำ
เกี่ยวกับบริษัท
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