Data Management Operations Lead

An internationally known biotechnology company has an opening for a Data Management Operations Lead job at their Maidenhead office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.

Job Responsibilities:

• Accountable for development of timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and vendors on assigned studies
• Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress.
• Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
• Develops risk mitigation or action plans and oversees execution when appropriate.
• Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Portfolio Lead.
• Primary contact between DM and clinical study management teams (SMT). Liaises directly with internal customers (Biometrics functions, Clinical, Medical, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
• Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed
• Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM Portfolio Lead, DM management. Develops appropriate risk mitigation, as needed
• Support study-level/drug program audit and inspection readiness activities as needed
• Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project.

Skills and Requirements:

• 8+ years relevant work experience with a focus on clinical data management, 4+ years as a Trial Data Manager with full accountability across study start-up, conduct, and lock.
• Robust experience with Medidata Rave and the use of Data Review tools such as J-Review or Business Objects required.
• Deep understanding of drug development and biopharmaceutical industry required.
• Experience overseeing outsourced clinical trials work.
• Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor.
• Deep knowledge of clinical data management outsourcing operating model to functional-service providers and full-service/global CROs.
• Demonstrated use of insights to deliver effective marketing strategies.
• Demonstrated use of insights to deliver effective marketing strategies.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Eleni Boumpa at +44 2074400633 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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