דרושים ב-Boston Scientific ב-Taiwan

Position : Sr. Clinical Research Associate
Work Mode : Remote in Country
Requisition ID : 8300684
Additional Location(s): Taiwan

About the Role:
This position will cover site management and role of lead monitor in study team.
- As role of CRA : Monitor progress of clinical studies at the site level to verify that the rights and wellbeing of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start-up, enrollment, follow up and closure of clinical trial activities.
- As role of Lead MCRA : Integrates the centralized monitoring of clinical data recommended by global regulations into a role that is the primary centralized contact for identified studies.

Your Responsibilities will Include:
• Team Leadership: LMCRA s will have the primary responsibility for all Site Management deliverables and be the primary point of contact for the study team. Lead and mentor study monitoring team for site management.
• Study Planning and Risk Management : LMCRA will work in conjunction with the CTM/CPM and the SME to involve in the development of study RACT, Monitoring plan and Risk management plan from a site management point of view. Monitoring visit compliance, support and answer MCRA questions, handle issue escalation and facilitate study compliance meetings.
• Source Verification: conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.

• Communications: ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence.
• Training: ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
• Site Compliance: ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection acti
• Event Reporting: ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
• Collaboration: participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases.
• Documentation: Manages study contracts, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.
Required Qualifications:
• Bachelor’s degree in Life Sciences, Nursing, or a related field with 5+ years of experience in clinical research monitoring or related roles.
• Strong understanding of GCP, ISO, and other applicable regulatory requirements.
• Proven ability to perform source verification and ensure data accuracy and completeness.
• Ability to travel approximately 50% of the time.
Preferred Qualifications:
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Experience in medical device clinical trial
• Certification in Clinical Research (e.g., CCRP, CCRA) or equivalent.
• Excellent written and verbal communication skills, with experience in report writing.
• Experience managing multiple projects or studies simultaneously, demonstrating strong organizational skills.

BSC TW

JOB TITLE:

Senior Supply Chain Specialist

JOB DESCRIPTION:

Supply Chain Planning (60%)

• Responsible for planning activities for assigned Business Units to support a complex business model via effective S&OP process to align with financial objectives
• Review sales trends, understand drivers and provide inputs into Planning Platform and evaluate forecast results
• Monitor and improve product availability in conjunction with identifying initiatives to optimize inventory level at both DC and consignment sites
• Manage KPI performance including Forecast accuracy, Forecast Bias, Backorder, Inventory Level, and Scrapping Cost

Project Management (40%)

• Work closely with local and regional stakeholders to streamline and harmonize end to end order to cash, and consignment inventory management process in Taiwan
• Identify the opportunities and the necessary operational resources required for project activities, including but not limited to automation agenda to simplify and digitize existing work process
• Assist in developing and delivering an appropriate project business plan, including resources, costs, return on investment, and timing, implementing permanent changes to business practices to ensure the company's overall effectiveness
• Responsible for cross-functional communications and stakeholder management

QUALIFICATIONS:

• 4+ years’ experience in supply chain or project management role
• Ability to identify problems and solve them proactively, innovatively, and collaboratively
• Strategic Thinking and business acumen
• Prioritization skills
• Influencing skills

BSC Taiwan

The trainee program will last for 12 months. The Trainee position is tailored for ambitious recent graduates eager to make their mark in the medical device industry. We seek candidates ready to learn the essentials and grow into confident Clinical Specialists. Key responsibilities include acquiring comprehensive RM clinical knowledge through rigorous training, observing medical cases, and achieving pertinent certifications. Trainees will also actively support Rhythm Management physicians with patient follow-up, system setup, product demonstrations, troubleshooting, and case assistance.

The trainee program will last for 12 months. The Trainee position is tailored for ambitious recent graduates eager to make their mark in the medical device industry. We seek candidates ready to learn the essentials and grow into confident Clinical Specialists. Key responsibilities include acquiring comprehensive RM clinical knowledge through rigorous training, observing medical cases, and achieving pertinent certifications. Trainees will also actively support Rhythm Management physicians with patient follow-up, system setup, product demonstrations, troubleshooting, and case assistance.

1. Bachelor or master’s degree in biomedical engineering.
2. Year of 2023/2024 graduates
1. Be willing to travel to all major hospitals in Taiwan
2. Be willing to work on weekends to support medical seminars
2. Be agile to seize opportunities to contribute to and learn from seniors
3. Adapt to challenges and changes

•Develop well thought out business plans and account profiles and execute sales and marketing strategies to achieve planned targeted revenue for those product lines responsible for.
• Develop business opportunities with new and existing clients to maintain product loyalty, and increase market share. This includes identifying Key Opinion Leaders and building strong business relationships with these customers
•Conduct sales reviews including market share analysis and adjust strategies & tactics accordingly to ensure execution of plans are in line with divisional or country goals.
• Maintain close relationships with key accounts and ensure full customer satisfaction by providing appropriate BSC products and services in response to the customer’s needs. This involves appraising customer needs and advising on product application or services.
•Provide clinical and technical support during cases and inform the clinician of patient treatment options. Engage customers in meaningful clinical discussions – which can positively impact patient outcomes – while being present in the procedure.
•Monitor territory sales performance on an ongoing basis, initiate corrective actions, and prepare reports, summaries, analysis and documentation an all aspects of the territory’s management.
• Conduct product in-services, including physical demonstrations using non-sterile product and evaluations for successful account conversion.

BSC Taiwan