Senior Clinical Data Manager (440768)
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POST DATE 9/13/2016
END DATE 10/12/2016
JOB DESCRIPTIONAPPLY Job Description:
OVERVIEW:Acts as a Lead CDM across programs/studies overseeing all Data Management (DM) activities performed internally or by CROsDM representative in Core Study Team Meetings for assigned Program(s) Primary point of contact for DM at the Global Program Team.Ensures consistency on the design of the trials within program(s) (standard CDASH CRFs, edit checks, clinical data review guidelines, CRF completion guidelines)Coordinate all DM activities performed by CRO/Vendor(S) and internal cross functional team Study Team members. Oversees the study start-up, conduct & finalization for Data Management activities within Program(s)Ensures study conventions, processes, knowledge sharing and best practice exist for program(s)/studies assignedLeads the review and implementation of Clinical Data Review Guidelines Defines requirements for data validation based on metrics generated and lessons learned from cleaning activitiesPlans appropriately to ensure adherence to timelines, including assignment of workloads and identifying resource and timeline issues within program(s)Mentors and trains new DM personnel and/or other team members as assignedSupports & assists junior staff for assigned trials Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement High level activities to be performed:Reviews and contributes to preparation of protocols, specifically related to Schedule of Events (SOE) and Data Management sectionParticipates in Investigator/KOM meetings Provides expertise to the team for DM processes and deliverables Performs and obtains input from study team members for DM study start-up activities including preparing or reviewing the eCRFs, eCCGs, DMP, and performing User Acceptance Testing (UAT), database go-live Responsible for ongoing review of data, database maintenance and creation / maintenance of study documentationAccountable and responsible for ensuring data quality and timeliness of study-related DM deliverables internally or from CROsCollaborates with CROs and study team members to identify and resolve issues that may impact deliverables Identifies and communicates data trends to study teamCollaborates with internal team and with CROs to pro-actively manage data availability and integrationCoordinates all DM Data Review activities and any other Clinical Study Team Data ReviewEnsures completion of all activities leading to the Study Database Lock (including medical coding and SAE reconciliation)Liaises with Statistical Programming and Biostatistics for data deliverables for IDMC and SDTM datasets Collaborates in the creation and maintenance of DM SOP/WI(s), Guidelines, and Forms as required Interacts with the study team members to define the necessary listings and reports needed to support study data validation, review and cleaning process. QUALIFICATIONS/EXPERIENCE:Exhibits strong leadership, communication (written and oral), interpersonal communication skills, logical thinking, attention to detail and problem solving abilities. Excellent project management, organizational, prioritization, and multitasking skills. Demonstrated ability to work independently.Experience in effectively collaborating with CRO s and external vendors. Experience with clinical data management systems, proficiency in EDC (preferably RAVE)Experience in basic SAS / SQL programming.Extensive experience of CDISC/CDASH and other industry standards.Experience with reporting tools like J-review is a plus.Full knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.Extensive CRO/Vendor management experience including day to day operations.Full knowledge of clinical data flow in clinical trial start-up, conduct, closing and submission.Works well in a cross functional team environment with and ability to work in a team to meet fast paced timelines and achieve deadlines. Education:Bachelor s degree and/or at least 10-12 yrs. of pharmaceutical experience, including data management and clinical trials
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