※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Position] Project Manager Associate Director
[Salary] 10〜17 million JPY ※Experiences and skills will be considered
The AD Project Management Country Operations (AD PMCO) is accountable within their region for the successful execution of study deliverables and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and consistency in timely completion of monitoring activities.
The AD PMCO is accountable for coordinating rapid start up activities across assigned countries in collaboration with the CRO. The AD PMCO will also drive adherence to timelines and milestones of study goals as well as identifying, managing and communicating risks to the study team and preparing mitigation plans.
The AD PMCO will ensure that the CRO assigned, dedicated, FSP or in house CRA monitoring activities at study sites results in the effective identification and problem solving of issues.
The AD PMCO will work with the CRO to revise study specific country plans and timelines. He/she will be accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations. The AD PMCO will also ensure that studies assigned in the country are appropriately resourced.
The AD PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.
The AD PMCO will coordinate with the Site Management Lead (SML) attendance at oversight site visits (onsite or remote) based on quality signals observed in the assigned studies, together with the CRO, dedicated CRA, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Engagement Visits.
- Proven experience in the oversight and delivery of operational aspects of all stages of the clinical trial process.
- Solid knowledge of clinical development processes, with previous project management experience.
- Ability to lead, troubleshoot and influence for quality and delivery.
- A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.
- Proven experience in effectively communicating with site staff including KOLs and thought leaders.
- Comprehensive and current regulatory knowledge, including GCP.
- Experience conducting GCP or other training is a plus.
- Flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).
- Good organizational skills and ability to deal with competing priorities.
- Effective communication skills (written, verbal and presentation).
- Creative thinker, curious and unafraid to ask questions.
- Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.
- Proficient with MS Office Suite (Excel, Word and PowerPoint).
- Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development.
[Preferred Knowledge, Skills and Abilities]
- A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,)
- 8+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience.
- Proven experience in managing high priority / complex studies through phases 1 - 4 and in rare medical conditions.
- Previous oversight and regulatory inspection experience.
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Director
Job Function: Health Care Provider