Lead Clinical Data Manager


Shire


Posted Under: Boston, Massachusetts jobs in Executive; Executive jobs in zipcode 2101
Posted On: 2017-11-24 20:00:00

The Clinical Data Manager will have a demonstrated ability to oversee the data management activities across multiple clinical programs. Provides Data Management leadership and expertise to project and study teams. Will have an in-depth knowledge of the end to end clinical research and data management processes, as well as global regulatory and industry rules and guidances (i.e. ICH, GCP) to support drug development processes and global project submissions through to approval. Responsible for managing data management components of project and study budgets and vendor performance. Mentors team members and more junior staff and may direct activities of contract Data Manager staff.

Responsibilities

30%

Delivering Excellence: Takes leadership role in project implementation



  • As a member of the clinical study or project team, ensures oversight of the Data Management external service providers; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the external service provider
  • Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
  • Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of data deliverables according to internal and regulatory standards
  • Mentors team members, junior staff or contractors via matrix relationships (internally or at external service providers) or direct supervision, by directing work, resolving problems and/or providing guidance
  • Supports the development and implementation of corporate and therapeutic area standards at a study and project level


    25%

    Accountability and Ownership: Drives accountability at every possible level



    • Ensures Data Management external service providers are delivering quality data and documentation on time, on budget and to Shire---s quality standards and SOPs
    • Reviews Data Management external service provider performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
    • Collaborates with external service provider and study team members to identify and resolve issues impacting goal attainment
    • Communicates closely with Data Management external service provider contacts outside of the project and study team in order to ensure that the external service provider is acting as an extended workforce
    • Assists in the development of proposal requests and/or budget grids, reviews budget proposals and may support selection of data management service providers
    • Budgetary accountability for DM portion of trial budgets


      15%

      Judgment and Decision Making: Evaluates immediate business impact and takes decisive action



      • Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve



        • Contributes to regular budget forecasting and cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results


          10%

          Courage to challenge: Takes risks and challenges norms to support tomorrow---s needs



          • Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to Data Management. Evaluates need for updates and modifications to improve individual project and overall organization-wide efficiency


            10%

            Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer---s decision making



            • Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines
            • As Data Management lead to the clinical study and project teams, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view
            • Leads development of Data Review Plans; contributes to other key study level documents (e.g. protocols, SAPs)


              10%

              Building Authentic Relationships: Building trusting relationships that will enhance current and future needs



              • Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success


                Education and Experience Requirements

                B.S. degree in Scientific or related field is preferred.



                • Minimum 8-10 years as a Sr. Data Manager and/or Manager within a Data Management organization
                • Experience with leading teams and/or organizations.
                • CCDM certification strongly preferred


                  Other Job Requirements

                  Travel :



                  • 1-2 domestic trips annually
                  • 1-2 international trips annually (Investigator meeting dependent)