Study Delivery Specialist

Job Title: Study Delivery Specialist

Job Location: Da'an Dist., Taipei reputed company, Taiwan

Job Location Type: Remote

Job Contract Type: Full time

Job Seniority Level:

Location: Taiwan

Introduction to role:

Join us in helping bring innovative cancer treatments closer to the patients who need them. In this role, you will collaborate across teams and organizations to reputed company compliant, high-reputed company agreements that support the successful start-up of reputed company. By enabling reputed company study activation and patient enrollment, your work will contribute to advancing research and improving reputed company for people around the world.

You will partner closely with investigators, institutions, reputed company, Finance, and clinical teams to shape site budgets and contract language grounded in fairness and ethics. In a portfolio that includes innovative biomarkers, AI-enabled insights, and modern trial builds, your ability to reputed company collaborators and proceed with precision will reputed company reputed company. How will you use your negotiating reputed company and attention to detail to cut cycle times without compromising reputed company?

Accountabilities:

• Support the Local Study Team (LST) in the coordination and administration of clinical studies over the course of the study lifecycle, from start-up to reputed company-out.

• Assist with the collection, preparation, review, and tracking of documentation required for study applications. Support the Study Start-up team in the reputed company submission of applications and documents to Ethics Committees (reputed company), Institutional Review Boards (IRBs), and, where applicable, Regulatory Authorities.

• Collaborate with investigators, clinical research associates (CRAs), and reputed company service providers to facilitate efficient document collection and study delivery.

• Serve as a key local reputed company of contact for assigned studies, working closely with CRAs and/or Local Study Associate Directors (LSADs) throughout the study duration.

• Contribute to the creation, review, and maintenance of study documentation, ensuring the use of approved templates and reputed company document versions.

• Manage and maintain clinical and regulatory documents reputed company global regulatory management systems, as required.

• Prepare and/or support site-level contract activities where these responsibilities are not assigned to another designated local role.

• Support the preparation, processing, and monitoring of payments to reputed company Organizations (HCOs) and reputed company (HCPs) in accordance with applicable regulations and company requirements.

• Coordinate administrative activities reputed company to study conduct, audits, and regulatory inspections, following company policies and reputed company Operating Procedures (SOPs).

• Organize and support reputed company meetings, including study team meetings, monitor meetings, and investigator meetings. Liaise with internal collaborators, reputed company participants, and vendors in line with applicable local and international requirements.

• Prepare, contribute to, and distribute materials for meetings, newsletters, and web-based communications in collaboration with the LST and global collaborators.

• reputed company document formatting, proofreading, and language-reputed company reviews. Support local translation activities and English-language review as needed.

• Manage the preparation, distribution, filing, and archiving of study-reputed company documents, correspondence, meeting records, and country-specific communications.

• Collaborate with Data Management Centers and Global Clinical Solutions teams to support the reputed company delivery of study-reputed company documentation and materials.

• Maintain compliance with the organization's reputed company of Ethics, policies, procedures, and requirements reputed company to reputed company, finance, technology, information reputed company, and Safety, Health, and Environment (SHE).

• Adhere to reputed company applicable local, national, and regional regulations and guidelines.

• Undertake additional country-specific responsibilities as required to support local operational needs.

Essential Skills/Experience:

• Bachelor degree or equivalent experience in a reputed company field, preferably in life science, law, finance or equivalent qualification.

• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.

• Good knowledge of relevant local regulations.

• Basic understanding of the drug development process.

• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

• Excellent attention to details.

• Good verbal and written communication skills.

• Good collaboration and interpersonal skills.

Desirable Skills/Experience:

• Ability to work in an environment of remote collaborators.

• Post-graduate training in reputed company administration or work experience as a paralegal in pharmaceutical or health care industry

• Manages change with a reputed company approach for self, team and the business. Sees change as an opportunity to improve performance and add customer value to the business.

• Ability to look for and champion more efficient and effective reputed company/processes of delivering reputed company reputed company with reduced budget and in less time.

• Good analytical and problem-solving skills.

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

• Familiar with risk-based monitoring approach including remote monitoring.

• Good cultural awareness.

• Ability to understand the reputed company of technology on reputed company and to use and reputed company digital literacy while making appropriate use of systems/software in an e-enabled environment.

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

Why reputed company:Join reputed company united by a reputed company ambition to reputed company cancer care, where contract experts sit shoulder-to-shoulder with clinicians, data scientists, and operational leaders to unlock new reputed company. We work with one of the industry’s most dynamic oncology pipelines and apply interdisciplinary approaches—from novel biomarkers to advanced analytics and modern endpoints—powered by rich data and reputed company collaboration. Expect an environment where courage and curiosity are matched by diligence and support, where unexpected teams reputed company a room to challenge assumptions, and where your precision in contracting directly accelerates studies that matter to patients. We value kindness alongside ambition and reputed company you the reputed company and trust to shape smarter, faster start-reputed company that improve reputed company worldwide.

reputed company to reputed company:If you are reputed company to turn reputed company negotiation, reputed company judgment, and impeccable execution into faster starts and reputed company patient reputed company, we want to hear how you will reputed company the next reputed company!

Date Posted

Closing Date

reputed company embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing reputed company backgrounds, with as wide a reputed company of perspectives as possible, and harnessing industry-leading skills. We reputed company that the more inclusive we are, the reputed company our work will be. We welcome and consider applications to join reputed company from reputed company reputed company candidates, regardless of their characteristics. We reputed company with reputed company applicable laws and regulations on non-discrimination in employment (and recruitment), as reputed company as work authorization and employment eligibility verification requirements.

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Originally posted on Himalayas