お仕事情報

お仕事情報

治験用ワクチン部クリニカルリーダー:SS-3481RTI

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界150 ヶ国以上、約7万人の社員を有するヘルスケア業界のリーディングカンパニー

求人コード SS-3481RTI
募集職種 治験用ワクチン部クリニカルリーダー
職務内容 1. Overall Responsibilities
JCL of Vaccine Research (called as Clinical Scientist in Pfizer Vaccine Research) applies extensive expertise and in-depth knowledge of clinical research to lead clinical research programs in Japan and/or other Asia pacific countries and registration activities across one or more clinical projects. JCL of Vaccine Research applies technical/scientific expertise to resolve problems regarding the clinical components of documents (eg, New Drug Applications, Common Technical Documents, registration dossiers, internal documents). JCL of Vaccine Research provides procedural and scientific subject matter expertise to guide other clinical staff members.
JCL of Vaccine Research will provide study-level medical and scientific support in conjunction with GMM of our Vaccine Research in Asia Pacific countries (including Japan). This includes assisting with protocol design and strategy, medical issue resolution, cross patient data review, creation of medical training and investigator meeting materials, decision point preparation, approval of patient narratives, review and approval of clinical data and audit response.

2. Major Duties and Responsibilities
1. Protocol and study design
a. Support Global Medical Monitor (GMM) and/or Global Clinical Program Leader (GCPL) of our Vaccine Research (PVR) with specific tasks as delegated
i. Protocol design and strategy
ii. Create medical training materials for Site Management
1. Specific medical/protocol training for RSMs and SMs
2. Site medical/protocol training for use during SIV
iii. Safety and protocol training at the investigator meeting
iv. Assist in preparation for consultant meetings
v. Complete clinical sections of Site Reference Manuals
vi. Participate in country feasibility as delegated by GCPL of PVR and site feasibility and selection as delegated by Regional Medical Monitor (RMM) (GMM in the country a study is a managed from)
b. Independently write/design, protocol synopsis, and protocol amendments of moderate complexity in collaboration with GMM, Global Trial Leader (GTL), Statisticians, and other relevant groups.
c. Lead strategy discussions of moderate complexity and actively participants in consultant meetings.
d. Create informed consent form (ICF)
i. Also, review of site ICFs as drafted by RSMs
2. Data review and interpretation
a. Lead medical input for, and participant in, database building/Integrated Data Review Plan/CRF design
i. Proactively coordinate with GMM of PVR to assure understanding and buy-in on deliverables throughout the process
b. Provide input for the design of Statistical Analysis Plan (SAP) and Clinical Data Presentation Package (CDPP)
c. Responsible for review of patient-level data across a study and coordinating with GMM for study-level review as delegated
d. Study analysis and decision point preparation
e. Interpret data and be able to identify issues of moderate/difficult complexity
f. Independently prepare efficient plan for medical review of data on moderate data independently
3. Study medical oversight
a. Collaborate with GTL to provide medical guidance during the execution of the study
b. Provide medical perspective in consultation with GTL during development of the monitoring plan
c. Answer specific Site Management protocol questions as needed (eg. during SIV)
d. Medical issue resolution (study wide, escalated regional/site)
e. Consulted during vendor selection for specific medical issues or questions
f. Identify and independently resolve study related issues of moderate complexity; consult with supervisor GTL for study related issues of difficult complexity
4. Safety
a. Track and reconcile SAEs across a study
b. Report SAEs during Safety Review Team meetings
c. Ensure timely communication of safety issues to sites
d. Review and approve patient narratives as delegated by GMM
5. Regulatory and publications
a. Provide in-depth scientific/medical input, review and edit clinical study report (CSR). Provide full review of content and integrated information from literature and other sources as appropriate
b. Support and contribute to various sections of regulatory filings
i. IB, IND/NDA Annual Reports
ii. Regulatory authority responses
c. Participate with GCPL and publication team to determine publication strategies
d. Audit response as delegated by GMM
応募要件 1. Routine application of standard principles of clinical trial design and standard scientific methods of data summarization, data analyses and data interpretation.
2. Direct experience with clinical trials with significant experience obtained directly working within industry/CRO.
3. Experience with study start-up to CSR completion from start to finish.
4. Limited exposure to drug development process with broad level of exposure in one of two areas
5. Demonstrated ability to integrate and summarize medical/scientific concepts in protocols and other documents
6. Strong understanding of basic physiological and pharmacological principles and advanced understanding of product, disease, market and TA
7. Specific knowledge in TA alignment
8. Skilled in protocol design
9. AE/SAE expertise
10. Written and oral communication, organizational, and cross-functional collaboration skills
11. Proficient at MS Word, Excel, and PowerPoint
勤務地 東京
年収 700万円~1200万円
最終学歴 大卒
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