メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

Position Summary:
A Lead, Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Lead, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Lead, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Lead, Local Trial Manager actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM). Compared to Associate, Local Trial Manager and Senior, Local Trial Manager roles, a Lead, Local Trial Manager is often assigned to more complex protocols and can work across Phase 1 – 3 studies in multiple therapeutic areas as needed to drive business needs. The Lead, Local Trial Manager may also perform the role of Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL) for single country as described in GCO procedural documents.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Lead Local Trial Manager
Education and Experience Requirements:
▪ A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience) is required.
▪ Minimum of 6 years of clinical trial management experience or a total of at least 8 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
▪ Specific therapeutic area experience is required and essential particularly for key therapeutic area. Should have an in-depth understanding of the drug development process including GCP and local regulatory requirements.
▪ Willingness to travel with occasional overnight stay away from home.▪ Minimum of 4 years of leadership experience. Computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills. Demonstrated ability to be consistently influential.
▪ Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs. Demonstrated ability to lead initiative/small teams.
▪ Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel in different disease areas, if required. Ability to anticipate obstacles and proactively provide solutions.
▪ Expected to be assigned to high priority and high complexity projects.
▪Oncology experience required (Internal applicants: Oncology experience is not required)


Sr Local Trial Manager
Education and Experience Requirements:
▪ A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
▪ Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
▪ Specific therapeutic area experience may be required depending on the position. Should have a good understanding of the drug development process including GCP and local regulatory requirements.
▪ Willingness to travel with occasional overnight stay away from home.
▪ Minimum of 2 years of leadership experience. Computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills. Demonstrated potential to be influential.
▪ Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.
▪ Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel. Ability to anticipate obstacles and proactively provide solutions.
▪ May be assigned to high priority projects.
▪Oncology experience required (Internal applicants: Oncology experience is not required)

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