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Lead Data Manager Ref: 23407

Salary:€48000 - €52000 per annum + 15% Bonus + Benefits + Full relocation

Added:09 Aug 2018

Region: Europe

Sector: Pharmaceutical

Sub Sector: Data Management

Responsibilities: - Lead Data Manager for multiple projects/trials from multiple franchises and providing professional Data Management input to Clinical Trial Teams - Responsible for ensuring consistency of protocols, project CRF's, clinical databases for all trials within assigned projects and provide technical feedback to CPO's as needed. - Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CPO proposal requests; provide input/create quotes. - Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans as appropriate. - Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases. - Monitor clinical data quality and progress of trials with CTS; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable. - Proactively identify project threats and resolve issues with clinical trial teams; escalate to CTS management if necessary and appropriate. - Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases. - Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues. - Provide input, review, and maintenance of local working practices and standards. - Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CTS. - Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff. Requirements: - University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree. - Fluent English (spoken and written) - Ideally 6 or more years' experience in drug development, with at least 4 years in Data Management activities. - Experience in managing outsourced studies or working for a CRO. - Understanding SAS output and introductory level skills with SAS. - Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding. - Project team leadership experience; good organizational and project management skills. - Ability to work independently, demonstrating initiative and flexibility. - Attention to detail and quality focused. - Good interpersonal and communication skills and ability to operate effectively in an international environment. - Good negotiation skills. Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners. Key Words: "data manager" senior data manager" "data management expert" "pharmaceutical" "CRO"

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