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Title:Associate Director - Clinical Data Management
Salary:Open
Experience:6+
Location:MA - Cambridge

Description:
Manage, direct and coordinate Data Management activities within a Group of projects (e.g. TA/BU) to enable all projects to be conducted to a consistently high standard with respect to cost, quality and timelines. . Management and development of Therapeutic Area (TA) based CDM staff . Ensuring that CDM procedures and processes meet business requirements and are adhered to . Communication between TA teams within CDM locally and globally . TA level resource planning for CDM . Assigning CDM resources to project teams . Ensuring clinical projects within the TA are executed according to set timelines . Responding to study audits affecting CDM . Ensuring international collaboration . Develop, review, implement and enforce global TA, CDM and Development standards.

Responsibilities:
  • Select, recruit, develop, manage, motivate, coach and appraise the performance of direct reports and ensure high quality performance management across DM Group.
  • Establish a partner and customer-orientated TA / BU.
  • Ensure provision of timely, efficient, high quality Data Management deliverables for clinical projects and trials within the Group.
  • Coordinate the activities of the Group in the management and documentation of databases from clinical trials.
  • Track and assign appropriate resources within the Group in line with Company priorities in order to meet timelines for Data Management deliverables.
  • Provide input to and undertake the implementation and maintenance of global working practices and standards.
  • Contribute to the development of the Data Management organization through his/her global leadership role on the management team.
  • Represent Data Management as well as other EDM partners at the CD&MA operations meetings and provide timely feedback to partners.
  • Lead and support clinical & non-clinical special projects.
  • Support the establishment of training programs (technical and professional skills) for DM staff and ensure staff training is conducted and properly documented.
  • Build relationships with TA colleagues in other functional areas globally
  • Lead cross functional international working groups
  • Contribute to the strategic direction of CDM globally
  • Oversee submission activities for the TA
  • Ensuring adherence to TA standards
  • Monitor progress of clinical projects within the DM therapeutic area
  • Produce weekly and monthly TA status reports
  • Provide CDM TA input to the planning of the study budget
  • Develop and maintain resource plan for the TA
  • CDM sign off of scope of work documents (SSW) for outsourced studies
  • Contribute to development of CDM outsourcing strategies and long-term relationships with insourcing/outsourcing partners
  • Contribute to the selection of preferred insourcing/outsourcing partners
  • Respond to questions and findings from Clinical Quality Assurance (CQA) and other departmental audits
  • Contribute to the continuous improvement of CDM and the wider Development organization globally
  • Develop, review and implement policies, SOPs and associated documents affecting CDM (local and international)
  • Recruit, manage, develop and train permanent and contract staff
  • Organize post study review meetings to gather lessons learned for communication to CDM departmental meeting
  • Organize and chair TA team meetings
  • Participate in and present at relevant focus group and committee meetings e.g Clinical Data Interchange Standards Consortium (CDISC), Oracle Clinical User Group (OCUG), Association for Clinical Data Management (ACDM/SCDM) etc.
  • Maintain and improve global collaboration
  • Promote and be an advocate of CDM internally and externally
  • Facilitation of inter / intra departmental communication

Requirements:
  • Ideally 8 or more years of experience in drug development with at least 6 years in Data Management activities.
  • At least 5 years line management or global project team leadership experience.
  • Strong technical and problem solving skills, and ability to evaluate computer systems for Data Management.
  • Excellent understanding of clinical trials methodology, GCP and medical terminology.
  • Ability to work independently, under pressure, demonstrating initiative and flexibility through effective and innovative leadership ability.
  • Attention to detail and quality focused.
  • Excellent organizational, planning, resource and global project management skills.
  • Excellent interpersonal and communication skills, and ability to operate effectively in an international environment.
  • Strong negotiation and diplomacy skills.
  • Excellent understanding of physiology, pharmacology and clinical study objectives and the drug development process.
  • Ability to mentor, coach within DM and cross functionally, and coordinate internal and external training.
  • Excellent people management skills with positive leadership, innovative, and collaborative behaviors.
  • Project Management and Planning (PMP) including multi-project responsibility
  • Working to regulatory standards in clinical research
  • Global collaboration with CDM Colleagues

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