Director Clinical Data Management
Priority Sales Recruiting - Miami, FL
Compensation: $90K-$110K Plus Bonus, co. equity and profit shares
Location: Miami, FL

Job Description:
Primary Responsibilities
Responsible for the direction and management of all internal data management activities by:
  • Managing department workload to assure equal distribution of work across teams
  • Providing guidance and oversight with regard to clinical data
  • Working with existing data management customers to assure that their data are effectively managed
  • Defining/redefining existing processes for data management
  • Managing projects for clients where we are providing data management services, including the management of all internal resources necessary to manage studies
  • Developing and ensuring compliance to study/client specific data management plans
  • Manages customer and protocol specific listing of active Data Management projects
Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by
  • Evaluating and monitoring workload of staff to ensure projects are on time; affecting change when necessary
  • Interacting with various internal and external groups to facilitate successful project completion
  • Developing and managing departmental initiatives/special projects
  • Implementing and managing the introduction of new technology and departmental tools
Serves customers by
  • Supporting client deliverables when necessary
  • Establishing, maintaining and monitoring Service License Agreements
  • Coordinates and executes data management-related documents, including Data Transfer Plan
Establishes relationships and serves as a point of contact for customers within the Data Services department by
  • Participating in customer kickoff meetings for new studies and projects
  • Attends customer governance meetings as needed
  • Regularly reaching out to key customers for feedback and to share the corporate message
Performs supervisory functions by
  • Communicating job expectations
  • Planning, monitoring and appraising job results
  • Coaching, counseling and disciplining staff
  • Identifying and developing key staff to eventually assume greater responsibilities and growth within the company
  • Initiating, coordinating and enforcing systems, policies and procedures
  • Approving direct reports time sheets, requests for time off and/or overtime
  • Performing timely performance evaluations of direct reports
  • Coordinating and conducting new hire interviews; facilitating hiring decision
  • Training new hires on Clinical Data Management processes and responsibilities
Increases stakeholder value by
  • Establishing functional objectives aligned with corporate mission
  • Initiating, coordinating and enforcing new strategic initiatives
  • Measuring and ensuring profit and service driven outcomes
Contributes to overall company communication, cooperation and efficiencies by
  • Communicating departmental updates to appropriate personnel throughout company
  • Always considering the impact of the department's processes and deliverables on other departments and the company as a whole when implementing and managing processes
  • Interacting frequently with other departmental supervisors and managers to keep abreast of their respective environments (e.g., new ideas, process changes, staffing concerns, etc.)
Maintains Quality Service and Departmental Standards by
  • Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
  • Establishing and enforcing departmental standards
  • Overseeing data management quality control throughout the life of the study
  • Developing and maintaining department process documents and work instructions
  • Reviewing and updating company SOPs related to the department
Secondary Responsibilities
Contributes to team effort by
  • Working with internal staff to resolve issues
  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to achieve results
  • Performing other duties as assigned
Maintains Technical and Industry Knowledge by
  • Attending and participating in applicable company-sponsored training
If you poses clinical data management experience and have a high level of technical apptitude and have worked at companies Quintiles, PPD, ICON and like companies.

Required Experience
  • 10+ years' experience in SAS Programming/data management in pharmaceutical research and development required, including data import, data cleaning, and custom report generation
  • 5+ years clinical trials experience within a CRO or pharmaceutical research organization and a minimum of 3 years line management experience
  • Understanding of medical and/or clinical trial terminology required
  • Proven ability in analyzing data
  • Working knowledge of GCP, ICH guidelines and FDA regulations
  • Working knowledge of other clinical trial data management tools such as Oracle Clinical, etc.
  • Experience working with computer software including Word, Excel and Access preferred
  • Experience with SDTM model a plus
Required Skills

  • Bachelor's degree computer science, life sciences or related field required.
Additional Skills set:
  • Strong interpersonal and communication skills, both verbal and written
  • Strong organizational and leadership skills
  • Goal oriented
  • Ability to promote and maintain a positive and professional attitude
About our client:
An award-winning, full service, global CRO specializing in Phase I - III clinical development for biologic, novel and specialty pharmaceuticals. Helping pharmaceutical and biotechnology companies accelerate the process of bringing safe, effective and reliable therapies to market.

Priority Sales Recruiting - 30+ days ago - save job - block
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