Chiltern is Europe's largest privately owned Clinical Research Organisation, with offices throughout Europe, both Eastern and Western, North and South America and in Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.
Due to expansion of our company we are looking for a Project Data Manager for our team in Madrid!
You will be responsible for planning, execution, and delivery of Clinical Data Management projects on schedule and within budget, and within Chiltern and/or sponsor Standard Operating Procedures (SOPs).
Duties & Responsibilities
1. Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing. 2. With guidance from line manager and more experienced staff, develop and implement project plans for relevant Data Management projects. 3. Serve as Data Management Lead on selected projects 4. Create project specific Data Management Plans (DMPs) 5. Provide input, assistance and/or oversight with preparation of edit check specifications for a specific project, Data entry guidelines preparation, Case Report Form design and associated specification 6. Assist with and/or oversee the creation of test data for entry screens and edit checks 7. Serve as primary contact for DM with all relevant parties including but not limited to Clinical Operations and Sponsor, informing stakeholders if there is a need to deviate from project scope or plan 8. Participate/attend Sponsor requested meetings as required 9. Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections 10. Perform other duties as required by the Department.
Education University degree in Medical/Life Science/Computer Science
Experience Minimum 0 -- 2 + years' experience leading Data Management projects
Skills and Attributes # Ability to maintain confidentiality of data and information during interactions with staff at all levels # Prior experience in the pharmaceutical, biotechnology, medical device/diagnostics or clinical trial industries. # Effective communication skills
For a confidential discussion about this opportunity, please telephone Baudi Heidanus on (0)6 .