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Principal Clinical Data Manager

5.00 to 0.00 Years   Hyderabad   02 Aug, 2021
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Serve as Lead Data Manager for multiple projects/trials from multiple franchises and providing professional Data Management input to Clinical Trial Teams (CTTs) and Data Review Teams (DRT) as applicable. Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to stakeholders as needed. Provide CDM input to study protocols and Study Specification Worksheets (SSW); provide assumptions to create RFP quotes. Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Data Management documents, 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 data collection providers; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable. For studies, which have central data monitoring, CDME (central data monitoring expert) will be responsible for all oversight of the data including DM deliverables. Will drive necessary actions as needed and ensure proper integration of central data monitoring requirements. Proactively identify project threats and resolve issues with clinical trial teams/data review teams; escalate to Data Sciences management if necessary and as appropriate. Ensure up-to-date and accurate tracking of report status and progress of data management activities 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 Data Sciences. Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff. Minimum requirements University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree with ideally 6 or more years experience in drug development, with at least 5 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. Good technical and problem solving skills. Ability to work independently, under pressure, 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.,

Keyskills :
data qualitycustomer relationsdata collectionclinical trialsoncologyclinical datadrug safetycost effectivedata managementdatabase administration

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