*Hi Associates, Hot Requirement* * *
*Senior Clinical Data Manager/Clinical Data Manager MUST HAVE PHARMACEUTICAL // Biotechnology Exp* Cambridge, MA long term contract *REQUIREMENTS/QUALIFICATIONS* Bachelor’s or equivalent degree in health-related field preferred with 3+ years of experience in clinical data management in the pharmaceutical/biotechnology industry or equivalent; electronic data capture experience and working knowledge of Oncology and/or Inflammation indications, SDTM and C-DASH principles desirable *RESPONSIBILITIES* - Primary Data Management (DM) contact and contributor for assigned clinical project(s) / program(s) - Serves as a member of Clinical Study Teams - Monitors timelines and ensures that clinical data management deadlines are met with quality - Liaises with third-party vendors such as CROs, EDC vendors and central laboratories in a project-manager capacity in support of timelines and data-related deliverables - Responsible for working with database builders to develop EDC databases and revisions - Help develop specifications and UAT requirements for database and test according to UAT Plan - Specify requirements for electronic and manual edit checks - Create and revise data management documentation - Review and query clinical trial data per the Integrated Data Review Plan and Data Validation Specifications - Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders - Train clinical personnel on CRF and EDC, as needed - Coordinate with Pharmcovigilance on adverse event reconciliation - Review and provide feedback on protocols, Statistical Analysis Plans and CSRs - Provide leadership for cross-functional and organization-wide initiatives, where applicable - Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities - Ensures adherence to data management standards - May train and/or supervise the daily responsibilities of more junior staff as assigned *TECHNICAL KNOWLEDGE* - Proficiency in the area of clinical data collection, cleaning and analysis - Demonstrates superior project management skills - Understanding of ICH and regulations as they pertain to data management - Working knowledge of at least one EDC system - Understands and routinely considers the big picture - Experience with SDTM/C-DASH is a plus Thanks and Regards, Ryan Marshall | Panzer Solutions LLC 45 Stuart Ave, K Norwalk CT 06850 USA Direct:203 652 1444 ext 127| Fax: 203-286-1457 , E-mail:[email protected] Notice of Confidentiality: The information contained herein is intended only for the confidential use of the recipient. If the reader of this message is neither the intended recipient, nor the person responsible for delivering it to the intended recipient,you are hereby notified that you have received this communication in error, and that any review, dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this in error, please notify the sender immediately by telephone, and destroy this e-mail message OR reply with the subject “REMOVE” such that your email would be taken out of our distribution. -- You received this message because you are subscribed to the Google Groups "Oracle-Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/oracle-projects?hl=en. For more options, visit https://groups.google.com/groups/opt_out.
