Clinical Lead, Taiwan at Emerald Clinical Trials

Taipei, , Taiwan -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

0.0

Posted On

19 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Study Management, Site Selection, Study Team Management, Timeline Management, Budget Adherence, Site Feasibility, CRA Management, Protocol Adherence, Monitoring Visit Report Review, Training Material Development, Data Management Assistance, User Acceptance Testing, ICH/GCP Compliance, Stakeholder Communication, Financial Analysis, Scope Change Management

Industry

Biotechnology Research

Description

Who We Are Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies. With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality. Global Expertise. Local Insight. Real Impact. Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes. Our 800+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward. About the Role The Clinical Lead (CL) is responsible for management & coordination of all clinical study management activities for assigned studies per the contracted Scope of Work (SOW), study startup activities including site selection, study team management, and project timelines for Emerald Clinical. The CL works closely with Project Leader (PL) and may support the sponsor, investigators, and appropriate staff in each department of Emerald Clinical as needed to help launch and complete the study. The CL will lead the clinical operation team (eg. CRAs) to manage trials and sites and have responsibility for assisting the PL with timelines and budget adherence with each trial. The CL also works closely with the PL and Clinical Trial Assistant (CTA) / Clinical Trial Specialist (CTS) during study startup to manage site feasibility and selection process. As part of the site management responsibilities, the CL manages the CRA activities under PM's supervision, reviews trip reports and expense reports as needed, and may assist with the performance of site qualification, site initiation, co-monitoring and/or close-out visits as needed. The CL is responsible for demonstrating professional demeanour and maintaining confidentiality in all interactions with both internal and external contacts. Your Responsibilities Clinical Management Lead the development and implementation of the Clinical Monitoring Plan (CMP), inclusive of tracking and management of protocol deviations, and supporting tools & templates with collaboration and review by appropriate sponsor and/or functional area leads as needed Facilitate site selection through feasibility questionnaire process, including input or creation of feasibility questionnaire in collaboration with the sponsors as outlined in the CMP or other study plans Oversight of protocol administration including pre-study work, initiation of sites, ongoing progress of trial and close out of sites, including development of study specific forms, annotated reports and customizing templates, as appropriate Working with the CRAs to ensure site protocol adherence and query resolution, including review for trends and identification of issues where additional training may be warranted Manage monitoring visit report reviews with assigned CRAs to meet timelines & metrics and corresponding expense reports, by project, as assigned or upon request Lead the development of training materials for investigator sites and the CRA team Helping to train data management on protocol and may work with the data management group throughout the trial to include assistance with CRF development, ongoing queries and data lock procedures, including participation of User Acceptance Testing (UAT) activities Assist with ongoing site management including interim calls to sites, addressing clinical questions from sites and CRAs in the field, and troubleshooting as needed Effective communication of protocol issues/status to all departments of Emerald Clinical, Sponsors and/or Vendors, as appropriate Team Leadership All clinical activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP and applicable country regulatory requirements. Maintain effective professional relationships with external customers, investigators and vendors. Maintain effective professional relationships with internal project team including those providing academic input. Provide clear guidance to clinical operation team on clinical specific deliverables as agreed with PL. A CL may also continue to undertake site management and monitoring, if they have had previous experience carrying out these tasks on an as needed basis. Collaborate with the study assigned PL to continually assess study team resourcing needs and make adjustments as needed, identifying if added resources are Out of Scope (OOS) leading to a change order Financial and Contractual Management Assist PL to analyze monthly financial reports for clinical aspect to identify trends and reasons behind figures, escalate as required. Ensure PL understand all clinical aspects of their project finance responsibilities and follow appropriate escalation pathways Maintain clinical aspects in utilization, revenue forecast and recognition identify and implement strategies for improvement (if required) and escalate any significant concerns to management Maintain gross margin across allocated projects to meet organizational goals. Review forecasts for all allocated projects for the clinical aspect in consultation with each allocated PL as needed, during month end billing and Project Finance Analyst meetings at least every quarter and develop contingency plans to address any project slippage Oversee pass through report management in clinical aspects to billing is finalized within agreed timelines Work closely with PL in clinical aspect of the project review reporting to ensure survey responses are accurate, timely and submitted within agreed timelines Assist PL to maintain list of all scope change documentation in clinical aspects, and may collaborate with Proposal team to update pricing tool/budget Seek opportunities for expansion of scope in clinical aspects and proactively follow up with BD & sponsor About You Educated to degree level in pharmacy, medical, nursing, biological science, or other health-related disciplines or equivalent relevant experience. Prior CRA experience preferred, with at least 5 years of monitoring, trial coordination or relevant industry experience Must have at least 2 years of working experience as a Clinical Lead / CTM or similar role Excellent working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions. Fluent in written and spoken English Must have exceptional communication skills in both verbal and written form Must have excellent organizational and time management skills Why Join Us? At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first—both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide. Here’s what makes us stand out: • Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology. • Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial. • Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges. What We Offer We understand that great work happens when people feel valued and supported. That’s why we provide: • Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience. • Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role. • Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role. • Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events. • Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients. Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal-opportunity employer and encourage applications from all qualified candidates.

Responsibilities

The Clinical Lead manages and coordinates all clinical study management activities, including site selection, study team leadership, and ensuring adherence to project timelines and Scope of Work. This role involves leading the clinical operation team (e.g., CRAs) and assisting the Project Leader with timeline and budget oversight for assigned trials.