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パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Senior Data Management Lead (South Africa)

求人ID 64897BR ロケーション 南アフリカ 仕事内容
Job Purpose:
The Senior Data Management Lead

* has overall accountability for the execution of the Data Management strategy from database setup through database lock and the Data Management technology set-up for the project.
* can competently and independently lead large, complex projects and/or programs.
* provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming.
* manages the delivery of all relevant data operations activities from database setup through database lock and data transfers.

General areas of responsibility include:
* coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.
* May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.
* May cover for the Clinical Operations Lead, if appropriately trained in the corresponding tasks.


Leadership skills that include:
o Building and leading global (virtual) teams
o Ability to work effectively with and motivate virtual teams
o Ability to negotiate and influence in order to achieve mutually beneficial results
o Proven problem solving skills
o Strong communication skills with a diplomatic approach
o Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
o Effective time management in order to meet objectives
o Ability to conduct root cause analysis in business problem solving and process improvement development
o Ability to make appropriate decisions in ambiguous situations

Personal skills that include:
o Excellent interpersonal, oral and written communication skills
o Ability to gain trust and confidence with a variety of clients as well as within Parexel
o Excellent learning ability
o Managerial courage, resilience, and ability to adjust to a rapidly changing environment
o Excellent presentation skills
o Work with integrity
o Ability to travel as required

Business / Operational skills that include:
o Strong customer focus, ability to interact professionally within a client organization o Understanding of Parexel project financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
o Commitment to quality
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
o Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS
o Basic knowledge of SAS

Knowledge and Experience:
* Substantial experience in clinical research
* Proven record of leading project and program teams in a technical/programming or data processing environment
* Strong understanding of cross functional activities
* Strong customer service focus
* Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures

* Bachelor’s degree and / or other qualifications in a science or industry related discipline
* Competent in written and oral English









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