Product/Brand Management Manager, Sr. jobs in San Jose, CA

Sr. Manager, Data Management

Objective of Position
The Senior Clinical Data Manager (Sr. CDM) is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock.  This person may have project-level oversight of junior data managers and/or Clinical Data Associates (CDAs).  The core duties and responsibilities of the Sr. CDM are delineated below.

Essential Duties/ Responsibilities 

Department/Management Level
    Participates in the development, review, and implementation of departmental SOPs, templates, and processes
    May have project oversight of internal clinical data associates, and data managers 
    Provide feedback and task assignment
    Supports budget and resource planning across assigned projects
    Contributes to technical infrastructure of data management
    Participates in CRO/vendor selection process for outsourced activities
    May participate in department or cross-functional initiatives

DM/Study Tasks:
    Represents data management in study team meetings
    Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
    Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
    Executes and/or distributes data management metrics, listings, and reports, as required
    Oversight of data management CRO/service providers
    Monitors the progress of all data management activities for the project to ensure project timelines are met
    Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
    Proactively identifies potential study issues/risks and recommends/implements solutions
    Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
    Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Requirements
    Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
    Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
    Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
    Good working knowledge of ICH, FDA, and GCP regulations and guidelines
    Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
    Knowledge of industry standards (CDISC, SDTM, CDASH)
    Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
    Proven ability to work both independently or in a team setting

Education/ Training
    Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health- related field
    Minimum 7 years of DM experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement
    CRO management experience desired
    3 years of managerial experience desired
    CRO management experience
    Prior oncology/hematology experience highly desirable