求人情報一覧

職務内容 ＜ミッション＞ 製薬企業におけるメディカルアフェアーズ部門における活動のDX化の推進 ＜担当業務＞ 2022年度に募集開始したポジションにおいて、将来のリーダー候補として事業の1⇒10（将来的には10⇒100）を推進していただきます 【提案推進】 製薬企業のメディカルアフェアーズ向けDX支援サービス（オンライン情報提供サービス等）の提案推進 【サービス提供】 サービス提供のためのプロジェクトの設計や進行管理 【サービス企画】 上記業務で得られるお客さまからの生の声をベースに既存サービスを更に高く付加価値向上に向けた取り組みの推進 （エンジニアとの機能開発、お客さまへの導入・展開等） 【組織運営】 事業成長を支えるためのメディカルアフェアーズDXグループならではの拡大に向けて、シニアリーダーとともにのテーマを推進する （例：育成の仕組み作り、事業詳細モニタリングの仕組み作り）

Review of analysis plans for appropriate methodologies; Development of analysis databases; Programming of study analyses and review of study results; Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis.

Provide oversight of preferred site relationships within assigned countries; Provide ongoing support of sites, including identifying and discussing future new business opportunities and feasibility assessments; Develop effective plans for site contact and follow-up; Serve as main point of contact for project teams regarding site performance issues and updates on pertinent site information; Support management in expediting feasibility, site selection and study start-up;

Contribute to the development of the Investigator budgets and payment schedules; Partner with Site Budget & Contract Managers and Contract Specialists on site Clinical Trial Agreements by providing and revising site's final Investigator budget; Provide oversight and track metrics for final Investigator budgets; Collaborate and liaise with IT, as needed, to ensure the proper setup of new studies in the Site Payments module of ClinTrak; Coordinate patient data loads prior to calculation of periodic site payments; Calculate and process payments to Investigators/Sites in ClinTrak; Coordinate with Finance to invoice Sponsor for funds needed to initiate and process payments to investigators/sites; Provide support for cumulative actual payments and projections for Investigator/Site payments;

Contribute to the development of the Investigator budgets and payment schedules; Partner with Site Budget & Contract Managers and Contract Specialists on site Clinical Trial Agreements by providing and revising site's final Investigator budget; Provide oversight and track metrics for final Investigator budgets; Collaborate and liaise with IT, as needed, to ensure the proper setup of new studies in the Site Payments module of ClinTrak; Coordinate patient data loads prior to calculation of periodic site payments; Calculate and process payments to Investigators/Sites in ClinTrak; Coordinate with Finance to invoice Sponsor for funds needed to initiate and process payments to investigators/sites; Provide support for cumulative actual payments and projections for Investigator/Site payments;

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.