Director, Data Management

Proclinical is currently recruiting for a Director of Global Management with a global pharmaceutical company located in Boston, MA. Successful candidate will provide Data Management leadership and expertise to Data Management staff, as well as project and study teams.

Job Responsibilities:

• Act as a member of the Clinical Information Management Leadership Team (CIM LT).
• Responsible for managing staff and clinical data management operational
  activities in order to achieve high quality databases, in a timely manner, to support drug
  development processes and global submissions through to approval, as well as directing and/or supporting infrastructure and technology initiatives and strategic vendor relationships.
• Take leadership role managing and deploy resources.
• As a member of the CIM LT, may ensure oversight of the Strategic Data Management vendor at the portfolio level; managing & reviewing metrics, identifying and solving cross portfolio issues, and ensures the Strategic Data Management vendors are building institutional knowledge and delivery systems.
• As a member of the CIM LT, may coordinate and manage opportunities for process optimization, interfaces with other departments and functions and coordinate user requirements for technologies and reports used to deliver data management services.
• Define needs for full time and contract resources to support projects. Supervise FTE staff and/or contractors by directing work, resolving problems and/or providing guidance.
• Provide Data Management expertise to teams and other Data Management staff in identifying opportunities for process and budgetary optimization.
• Ensure development and maintenance of SOPs, processes, and guidelines.
• Ensure overview and management of issues identified via internal & external audits.
• Ensure development of user requirements for standards, technologies, tools and/or reports needed to deliver Data Management services.
• Review Strategic Data Management vendor performance measures and evaluates cost/benefit of actions taken to remedy or improve performance.
• Collaborate with Strategic Data Management vendor Leadership to identify and resolve issues impacting goal attainment.
• Ensure conduct of and evaluates functional process assessments of Data Management external service providers to ensure services provided meet Shire's standards and specifications

Skills and Requirements:

• BS degree in Scientific or related field is preferred.
• 12+ years as a Sr. Manager and/or Manager within a Data Management organization
  including 5+ years direct line management experience.
• Experience with leading teams and/or organizations.
• Demonstrated ability to analyze resource needs, identify and hire qualified staff
• Ability to prioritize multiple projects, lead teams and work groups.
• Proven ability to negotiate and influence to develop solutions.
• Proven ability to manage and communicate effectively with external service providers
  including negotiating contracts, reviewing request for proposals, analyzing scope of work,
  budgeting and forecasting, review of accruals and invoices, and responding to inquiries
  and complaints.
• Must be able to independently present complex information to Shire management,
  professional organizations, Strategic Data Management vendors, external service
  providers and the medical community.
• Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook.
• Understanding and facility with CDISC/CDASH standards and system integration.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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