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Currently hiring: Scientific Data Manager (Clinical Trials)

Job Description: Scientific Data Manager

The Data Manager will play a leading role in managing the collection, review and reporting of clinical data and related activities during the planning, set-up, conduct, and close-out of clinical trials. He/she is responsible for ensuring clinical trial databases are built, tested and validated, data cleaning activities are performed on an ongoing basis from trial initiation through database lock, and data is archived. In addition, it is his/her responsibility to ensure the Data Management processes and systems used during the lifetime of a trial are properly documented and comply with regulatory requirements in Europe and the US. The Data Manager continuously evaluates the current processes, procedures and software capabilities, with a continual focus on process improvement.

Key Responsibilities:
  • Manage the cross-functional collaboration, development, and maintenance of the components of the Data Management Plan (DMP) and data management deliverables across multiple studies and sites;
  • Drive study set-up and initiation procedures, providing expert review and guidance for the production of Data Management deliverables including CRF/eCRF, eDiary/ePRO, database design and set-up, validation definition and programming, User Acceptance Testing etc;
  • Act as the advisor to the study Project Managers on data management from study start-up to close out;
  • Provide advice, escalate issues, and propose improvements at various levels;
  • Be the driving force in standardising health/clinical data management within Atlantia, with a knowledge of recognised clinical trial data standards;
  • Programming and developing consistency checks, reports and validation testing that helps to continuously improve the quality of the database, whilst identifying and recording nonconformities;
  • Contribute to the design of the study protocol, SOPs, and other relevant documentation;
  • Serve as primary point of contact for the client on data management deliverables. Attend client meetings and lead data management discussions;
  • Understand the scope of work and budget assigned. Identify out-of-scope work and provide revised costs with supporting documentation when required;
  • Ensure project milestones are met according to the project timelines. Provide updates through oral and written correspondence, project status and progress reports;
  • Evaluate processes and new technologies, and suggest revisions to increase productivity and efficiency;
  • Manage the interaction with data management vendors to ensure that data management tasks remain on target;
  • Ensure the proper collection, management, and storage of clinical trial data;
  • Perform quality control audits to ensure accuracy of clinical systems and data;
  • Coordinate the receipt and handling of data received from external vendors and directs reconciliation where applicable;
  • Review, analyse, and validate clinical research data to ensure consistency, integrity and accuracy based on project specific guidelines in preparation for abstract submissions, publications or regulatory submissions;
  • Provide technical advice and solutions to solve problems and improve efficiency;
  • Manage staff in accordance with Atlantia’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems;
  • Participate in external vendor qualification and selection;
  • Have good knowledge and experience of clinical research operations, including interpretation and implementation of ICH guidelines/FDA regulations;
  • Adhere to Atlantia and any other relevant third-party policies, SOPs or guidelines at all times;
  • Complete all assigned training, facilitate the development of others, and assist in the recruitment and training of new staff members;
  • Perform other duties as assigned.
Requirements:

Essential:

  • A minimum of 3 years of relevant work experience in a clinical research data management related role;
  • Advanced knowledge of Data Management processes and systems;
  • Solid understanding of clinical research process;
  • Candidates need to be self-driven, curious and creative;
  • Excellent written and oral communication skills;
  • Experience with web-based data management software tools;
  • Proficient in the use of Microsoft office technologies such as Word, PowerPoint & Advanced Excel, including VBA;
  • Good applied statistics skills and knowledge, such as distributions, statistical testing, regression, etc;
  • Proven leadership skills;
  • Excellent organisational skills and demonstrated ability to manage projects;
  • A high degree of motivation and ability to use initiative;
  • Detail-oriented with the ability to effectively manage multiple competing priorities;
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients.

Desirable:

  • Experienced in data science toolkits such as R, SAS, Python;
  • Previous experience managing clinical research data with knowledge of ICH-GCP;
  • Demonstrated data management innovation.

Education:

  • Degree or post graduate qualification in a technical discipline such as: Engineering, Science, Computer Systems Engineering, Software Engineering, Business Information Systems, Information Technology, Biotechnology, Data Analytics with at least +3 years of experience.

Interested on this research position? Send us your application at careers@atlantiafoodtrials.com