About the role
The Associate Manager, Clinical Operations is the Clinical Trial Operations individual responsible for the coordination of clinical operations required to initiate, execute, and complete clinical trials to drive on-time delivery of clinical trial milestones in accordance with all applicable federal, State, and local laws/regulations and Company’s policies, procedures, and guidelines. May act in support or lead role.
Education / Background
- College/University graduate or above (degree in healthcare or life science degree is a plus).
- 2 years of monitoring clinical research experience gained from a CRO and/or pharmaceutical/biotech industry.
- Strong English language written and verbal communication skills are preferred.
- Position to be based in Taipei, Taiwan.
- Ability to travel, as needed.
Responsibilities include, but are not limited to
- Accountable for all activities of site-related study execution of assigned studies / Monitors involving start-up, execution, and close-out. Accountable for the on-time and within-budget study execution of assigned projects, including but not limited to country and site feasibility.
- Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Acepodia Standard Operating Procedures (SOPs), Monitoring Plans, and quality standards in conducting clinical research.
- Ensure audit and inspection readiness of assigned sites. Advice on pre-audit activities for GCP requirements. Prepare and follow up the site and system audits, CAPA preparation, and implementation.
- Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and allocate resources in alignment with Acepodia research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions.
- May be responsible for being the country point of contact for CROs and vendors for an assigned study/studies.
- May participate in global/local task forces and initiatives. Responsible for activities as assigned by the manager.
Position Requirements, Relevant Skills & Experience:
- Certified Clinical Research Associate certification is preferred.
- Demonstrate strong organizational and project management skills, including excellent record-keeping skills and good documentation practice.
- Has advanced written and oral communication skills.
- Familiarity with immunology, oncology, and hematology fields is a plus.
- Experience in clinical patient management, preparing clinical site-facing documents, and ensuring compliance with protocol and GCP.
- Demonstrated business ethics and integrity.
- Strong interpersonal skills and team player.
- Computer literacy with high proficiency in MS Word, Excel, and PowerPoint.
- Interested in working in a start-up environment that is dynamic and fast-paced.
Contact Us to Apply
Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.