求人情報一覧

Responsible for managing contract & budget negotiations for assigned projects; Play a key role in managing timelines; Responsible for reporting contract & budget negotiation progress to internal and external project teams; and Serve as primary point of contact for internal and external project teams.

Oversee Data Management procedures on assigned projects Line manage a small team of Data Coordinators that work to support the assigned projects Develop and review data management documents for assigned projects Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members Serve as a data management lead on multiple clinical trials

Efficiently manage and successfully execute all aspects of global project start-up; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; Present during bid defenses, general capabilities meetings, and audits.

Efficiently manage and successfully execute all aspects of global project start-up; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; Present during bid defenses, general capabilities meetings, and audits.

Quality check on submission documents and site essential documents; Interaction with US Central IRBs, sites and international associates; Preparation and approval of informed consent forms; and Review pertinent regulations to develop proactive solutions to start-up issues and challenges.

Participate as part of a team on various projects Validate an entry database design Report metrics and data trends on projects Identify data conflicts and issues on projects Work with personnel from research sites globally to resolve data conflicts Reconcile data from multiple sources Create and update study documentation on projects

Line management of Clinical Research Associates (CRAs); Recruitment, initial and continued training and development of CRAs; Oversight and Management of CRAs to ensure CRAs are meeting expectations of core monitoring responsibilities; Tracking and management of CRA resourcing/allocation of assignment; and Manage turnover and retention of CRAs to meet company objectives

Serve as a liaison between Sponsor, investigative sites and Company; Negotiate contracts and budgets with investigative sites; and Collaborate with internal project team to ensure negotiations occur within timelines.

Effective Management of a project including: Coordinate and manage project start-up, project maintenance, and project close-out activities; Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members; Track study status including patient status, Case Report Form status, safety issues, timelines, etc.; Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external); Provide management oversight for Clinical Research Associates and Project Coordinators on project team; Interpret contract-related issues and coordinate company activities according to current scope; Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan; Communicate change in scope to Sponsor clinical team and Company Contract Manager. Provide input for following (when applicable): Study protocol Edit Check Specifications Data Analysis Plan Data clean-up results Analysis Final study report

Determine plan of action for incoming calls; Collect, process, and track incoming events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes.

Engage in clinical trial management on a day to day level; Work closely with the project CTM for timely delivery of recurrent tasks consistently with a high degree of accuracy; Compile and maintain project-specific status reports; Interact with the Sponsor, study sites, and internal associates; Create and maintain project timelines; and Coordinate project meetings and produce quality minutes.

Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s); Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Sponsor Standard Operating Procedures (SOPs); Serve as the primary resource to the clinical investigator and site staff; Maintain close collaboration, interaction, and effective working relationships with internal cross-functional teams; Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak ® Monitoring Portal;

Responsible for development and maintenance of Data Management documents on assigned projects Represent Data Management for assigned projects in external audits (Sponsor or PMDA) Oversee Data Management procedures on assigned projects Line manage a team of Data Managers and/or Data Coordinators Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members Troubleshoot and provide logical solutions to Data Management issues that arise during course of trial Maintain effective communication with senior management so that they are aware at all times of critical issues confronting the projects and the action plans that have been put in place to address those critical issues Serve as a program data management lead on multiple clinical trials

Develop fee estimates for requests for proposals (RFPs), budget revisions, and contract amendments; Provide financial input for response to requests for information (RFIs), and ensure coordination of all information with other relevant personnel as required; Understand existing customer or potential customer’s business, pipeline, and opportunities in order to approach customer with confidence and knowledge; Be responsible for ensuring that bids meet customers' expectations and specific requirements; Have thorough knowledge of the bid process; Review proposal text assumptions to ensure the fee estimate and proposal text assumptions are consistent; Maintain and track ongoing performance of project against budget and notify internal and external clients when potential issues or changes are noted; Review invoices and other financial reports prior to Sponsors receipt; Analyze financials to assist in negotiation of agreements; Draft and review contracts for business implications;  Generate and initiate processing of contracts and monitor/report on changes in scope, invoicing and/or contract modification to ongoing contracts; May be responsible for other projects and responsibilities as assign

ご入社後、クライアントである製薬企業のMR活動に携わっていただきます。 【配属先企業】　外資系製薬企業 【ご担当領域】　脳神経外科領域（脳動脈瘤によるくも膜下出血後の脳血管攣縮抑制の薬剤） 【仕事内容】 医療施設を訪問し、ドクターを始め医療従事者に対して医薬品の品質・有効性・安全性などに関する情報の提供、収集、伝達を主に行っていただきます。

ご入社後、クライアントである製薬企業のMR活動に携わっていただきます。 【配属先企業】　内資系製薬企業 【ご担当領域】　輸液、経腸栄養剤 領域 【仕事内容】 医療施設を訪問し、ドクターを始め医療従事者に対して医薬品の品質・有効性・安全性などに関する情報の提供、収集、伝達を主に行っていただきます。