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Senior Clinical Data Manager

Cambridge, Massachusetts 02139

Post Date: 04/26/2018 Job ID: 1901 Job Category: Clinical: Data Management

As a member of our growing Data Management team, you will significantly contribute to the success of the DM function by having a large impact and leading the DM tasks on assigned projects.  You will work with a team-oriented and dedicated group who will welcome your innovative ideas while motivating and challenging you along the way.

This position works with clinical, biostatistics, and contract research organizations (CROs) to ensure that data management activities are performed with quality according to project timelines.  This position will manage all data management activities from CRF design through database lock for in-house and outsourced clinical trials with minimal supervision.

Responsibilities:
  • Independently lead and represent Data Management (DM) for all DM activities of an assigned study or assigned studies within a program 
  • Initiate, facilitate, lead and document all DM project management activities, e.g. DM deliverables, DM meetings, minutes
  • Establish rapport and maintain positive, open communication with internal and third-party teams
  • Mentor, lead and provide DM guidance to junior level DM team members
  • Will delegate DM activities to junior level staff as needed for assigned studies and independently perform ongoing data quality reviews, provide training and direct study team members to ensure data quality
  • Will be the DM subject matter expert for DM process questions from CROs, third party vendors and cross functional areas, e.g. Clinical Operations, Medical, Biostatistics, Programming, PVG, IT
  • Will review upcoming DM deliverables and forecast resourcing requirements as needed to execute ongoing and upcoming DM activities within timeline and budget requirements
  • Participate in reviewing requests for proposals (RFPs) and providing budgetary, contractual and scope of work (SOW) feedback for the DM functional area
  • Able to execute all activities required of the Senior Clinical Data Manager position:
  • Works with clinical, biostatistics, and CROs to design and develop study documents including Case Report Forms (CRFs), CRF Completion Instructions, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format
  • Manages the CROs to ensure that outsourced data management tasks remain on target according to project timelines and within budget
  • Manages third party vendors including review of data transfer specifications, managing data deliverables, reconciliation and ensuring quality transfers on time and within budget
  • Proactively organizes ongoing data review within clinical and biostatistics throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies

Oversee and perform, as necessary, the following tasks:
  • Serve as the primary point of contact for DM functional area
  • Drive study setup, maintenance and lock activities
  • Plan and perform user acceptance testing of clinical database (CRF and edit checks)
  • Generate, review and approve data management plans
  • Review and approve data transfers and other deliverables from external sources
  • Lead cross-functional discussions to define data handling and database design standards
  • Define and manage timelines to meet deliverables on time and with quality
  • Generate and disseminate project status reports to management
  • Manage CRO/data management specific vendor activities, timelines, and budgets
  • Participate in data management initiatives such as evaluate technology vendors (i.e. EDC, analytic tools), author and review SOPs, and establish data collection and reporting standards


Qualifications:
  • Minimum 5 years of experience in CRO, Pharmaceutical or Biotech Clinical Data Management and 2 years as a Lead CDM
  • Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations
  • Experience with Medidata RAVE, SAS and Coding tools
  • Awareness and familiarity of statistical methodology
  • Ability to solve complex problems in all areas of data management
  • Effective communication skills, both verbal and written
  • Strong attention to detail
  • Bachelor’ s degree required 

Demeika Roberts

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