Job Description

Keyrus Life Science is looking for an Oversight Data Manager who will join a team on client's site to direct and have the responsibility to create and design a database for the clinical studies you are assigned to.

As an Oversight Data Manager, you will design data entry screens where the concerned investigators will encode the relevant data during the clinical study. You will be programming and developing consistency checks, reports and validation testing that will help you to improve continuously the quality of the data base. A Clinical Data Manager also identifies and records the non-conformities in the quality of the data in the database. As a consequence of your quality commitment, you will be responsible to write functional requirements and technical instructions. Those documents are related to the study you will develop.

Your main tasks will be: 

• Coordinate the organisation (analysis planning), the set-up and the management of the operations.
• Ensure a qualitative management of the client relationship.
• Follow study progress: respecting deadlines, costs and ensuring the quality of the project according to the requirements, progress tracking sheet, data analysis, problems diagnosis and solutions.
• Ensure project progress and to set-up required actions during the study to meet deadlines.
• Coordinate the different collaborators on reporting projects.
• Responsible for the follow-up of results and for the organisation of progress meetings with the client.
• Coordinate the data quality control.
• Prepare the reporting documents and tools to follow study progress: ensure the set-up indicator of performance, quality and follow-up of budget.
• Ensure the training of the team.
• Respect of quality commitments.
• Participating in continual improvement of the Quality System.
• Identifying and to record nonconformities.
• Writing of documents such as functional requirements, user instructions, technical instructions.
• Development of SAS programs.
• Optimisation and standardisation of SAS programs.
• Performances of tests, writing UATs, Validation of user tests.
• Monitoring and advice for SAS programming.
• Programming and development of reports.
• Respect of Quality Commitments.
• Participating in continual improvement of the quality System.
• Identifying and to record nonconformities.

Profile

For this role, you gained a first experience (around 4 years) as Programmer or Data Manager. You have a good knowledge of the SAS Software, Oracle Database and SQL Language. You have strong communication skills (written and verbal) in English. Any knowledge about CDISC format and SDTM is a plus.

• Good command of SAS (Base, Stat, Graph, Macro)
• Study coordination skills
• Knowledge of GCP and ICH guidelines
• Knowledge of SQL, PL/SQL programming
• Experience in SAS is important 
• Knowledge of CDISC-SDTM
• Knowledge of the clinical environment
• Languages: English and French (oral and written)
  
  

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high calibre staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

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