メディカルリサーチマネージャー

Job Details

＜職務内容＞

・Study operation & execution (80%)
・Protocol development:
-Develop study protocols for SRAs and Phase IV studies together with the Medical
Managers
-MRRC process management
-Manage and co-ordinate submission and facilitate MRRC review process for SRAs, ph IV protocols and IITs
-Manage and ensure MARS system is up to date
-Act as main point of contact for Global MRRC and MRO teams
・Study management:
-Manage vendor selection and management, responsible for vendor training
-Manage and assess CRO performance: track and manage agreed study milestones from study start to study closeout (including CSR finalization)
・Data analysis management:
-Co-ordinate with Global Medical resources to ensure speed and accuracy of data
analysis for local study protocols
-Facilitates work with local vendors for data analysis when needed
・Contract and study payment management:
-Own and co-ordinate study vendor / institution contracts for all post-marketing
research activities
-Review and confirm vendor & institution payment milestones
・Operation Excellence (20%)
-Ensure appropriate local study SOPs align with all global SOPs as applicable
-Act as project manager for J-MRRC process
-Continually identify and execute process improvements to enable business performance
-Audit readiness: process and documentation check according to local and global SOPs for all post-marketing research activities

＜応募要件＞

・Bachelor / Master Degree in Science
・Business English and Japanese
・PMP or other project/program management certification preferred
・At least 5 years in a pharmaceutical industry and/or CRO role with in-depth experience in project management and post-marketing study management
・Fast Learning ability
・Excellent communication skill
・Good team player, fits in the environment with international, diverse, teamwork culture
・Strong customer orientation, science based

＜会社概要＞

革新的医薬品の開発に取り組むグローバルバイオファーマです。現在新薬発売に合わせ、日本法人の組織体制も充実させるとともに、社員の働きがいを後押しする人事制度の拡充も図っています。

＜注目ポイント＞

注目度の非常に高い製剤をパイプラインに持つバイオファーマから、メディカルリサーチスペシャリストの募集です！医師主導治験に関わっていただくポジションで、今後そちらの製剤が上市された場合に非常に重要なプロジェクトにも関わっていただけるまたとないご活躍の機会となります。ご興味がございましたら、是非お早めにお問い合わせください！