Genesis Pharma are currently looking for a Head of Data Management to join a leading Pharmaceutical company based in Paris.  Full time position with fantastic benefits available to all employees from day 1 and high competitive salaries.

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Company is constantly growing due to great results and winning new projects. They offer competitive flexible packages along with bonuses and provide full visa sponsorship along with relocation packages.

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Head of Data Management

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Responsibilities

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• Manage Data Management Department in order to ensure efficient conduct of the activities characterized by an adequate staffing, compliance with company quality expectations and respect of the projects timelines.

• Support the Head of Biometry in his management responsibilities by:

• Developing and coordinating Data Management departmental and individual objectives ensuring team motivation and personal development,

• Developing, implementing and monitoring performance indicators to evaluate the efficiency of the department and support its on-going optimization.

• Ensure the innovation and validation (according to effective systems of references) of The Company electronic data capture tools.

• Coordinate the writing and validation of Case Report Forms and Data-Management documents.

• Provide expert input during the design and development of Clinical Study Protocols.

• Responsible for the accuracy and reliability of databases generated by, or on behalf of the Company Biometry.

• Coordinate Medical Coding and Serious Adverse Events reconciliation activities

• Assure efficient operational interfaces between Data-Managers, Project Teams and Statisticians.

• Ensure technical/regulatory intelligence regarding the evolution of methods and tools in the data-management fields and the regulations/legislation applicable to Data-Management (21 CFR Part 11, ICH …)

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Line management

Head of Biometry

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Background

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• Post-graduate degree in computer science (BAC +5, Standard Profile: Master2 in bioinformatics)

• Fluency in English

• Prior experience in Data-Management (at least 5 years)

• Knowledge of international standards for data-management (ICH, CDISC, 21 CFR part 11)

• Fluent use of computer tools and data-management softwares (like Ennov Clinical software suite, or Medidata Rave)

• Working Knowledge of SAS

• Well versed with Oncology Clinical Trial set up (RECIST 1.1, PSA etc.)

• Good working knowledge to deal with paper CRF’s and eCRF’s

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To apply for this role, find out more about this or other roles, please forward your most up to date CV to Natalie.hough@genesisglobalgroup.eu and a member of the Genesis Pharma team will be in contact as soon as possible.

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TAGS: DATA MANAGEMENT