Manager, Clinical Data

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Location
Boston, MA
Salary
$115,000 - $130,000
Job Type
Direct Hire
Date
Dec 07, 2017
Job ID
2548768
GR Identifier: $Medd, $SECU, $CMPS



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This position is responsible for hiring, training, developing and retaining qualified Clinical Data Analysts (CDA) and Clinical Data Coordinators (CDC). Has primary management responsibility directly or through subordinates for all data related in support of clinical studies.  This position is accountable for the oversight and performance of the CDAs and CDCs and assures that quality of services and timely delivery meets internal and external customer requirements. The DM Manager must also exercise judgment in planning and organizing CDA and CDC workload; monitor CDA and CDC performance, set CDA and CDC goals and objectives, and track progress. They are also responsible for continuous process improvement within the global clinical data management group. 
 
Job Duties
  • Responsible for hiring and retaining a diverse, highly qualified data management professionals and for providing career coaching, growth, and personnel development.
  • Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
  • Oversees all data management activities including Case Report Form (CRF) development  and CRF Completion Guidelines, Edit Check specifications development, Data Management Plan development, Data Quality checks and discrepancy management, analyzing data, identifying trends; preparing data tables for reports and analyses, Study Database setup testing and Edit Check programming testing, External data handling, data entry guideline development and data entry to ensure regulations are met, best practices are followed and quality data is achieved. Is the point of escalation for issues with staff or projects.
  • Works collaboratively within Clinical Data Operations management team to enhance efficiency/effectiveness of the group by identifying needs for further automation, for improvements in the study database set up and maintenance processes, and appropriately balance workload between Data Management and Data Systems. Report or communicate progress and/or issues to upper management. Drive efficiencies within the department.
  • Ensures staff is appropriately trained on processes and procedures; ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors.
  • Maintains a safe work environment and a strong customer focus.
  • Models optimum leadership competencies to inspire an energized, empowered and accountable work force, ethical behavior, favorable community image, and actualization of the company’s values.
  • Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Assures that quality of services meets internal and external customer requirements.
  • Remains current on developments in field of expertise through literature, trade journals, professional associations, and by attending conferences. Decisions and recommendations have a critical impact on projects or operations.
  • Interfaces with personnel in various departments including Clinical Studies, Regulatory, R&D, Legal, Field Clinical Engineering, and Marketing as it related to data management activities.
  • Works with the Clinical Study management, Clinical Research Associates (CRA), Field Clinical Research Associate (FCRA), Field Clinical Engineer (FCE), Bio Statistics and Safety groups to define study related processes. May also be part of a project team where frequent exchange of information is required; may be team member or leader and contributes to achieving team goals.
  • Interacts with representatives from research facilities, universities, hospitals, physicians, and other health professionals, software user groups, and software application/solution vendors as appropriate to define requirements.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Supports internal audits and assist in regulatory inspections as appropriate.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
 
Required Qualifications
  • Requires a Bachelor's Degree in a science related field or equivalent.
  • Typically a minimum of eight plus years of progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry
  • Must be able to apply the fundamental concepts and practices to conduct needs assessment, research and develop information for market development purposes.
  • Must possess advanced personalcomputer skills (experience with Microsoft Office or equivalent required) in graphics, word processing, databases, etc.
  • Requires having comprehensive leadership skills, including the ability to coach and counsel others.
  • Must have advanced written and verbal communication, interpersonal, presentation, analytical, organizational skills, the ability to meet deadlines as well as the ability to communicate with all levels of individuals.
  • Evaluation, originality and/or ingenuity required.
  • Previous experience managing direct reports
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work effectively within a team in a fast-paced changing environment.
 
Desired Qualifications
  • An advanced degree in a relevant discipline is preferred.
  • Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, related programs, and experience in managing regulated studies such as Investigational Device Exemption (IDE), CE Mark or equivalent clinical data are highly desirable
  • Experience working in a broader enterprise/cross division business unit model preferred.
  • Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
  • Ability to travel approximately 20%, including internationally