The position is responsible for line managing, developing and being accountable for the Clinical Data Processing, Clinical Coders, Clinical Data Associate or Project Data Managers in their assigned team; and for meeting assigned operational targets including but not limited to quality, performance, utilization, retention and training.
• Ensures project launch, conduct, and closeout activities are performed according to the Customer's and the Company's contractual agreement. Ensures that all project-related data management tasks are completed in accordance with internal and customer quality standards, Syneos Health SOPs, and all pertinent industry/regulatory guidelines and legal requirements from commencement to closure of a project. Ensures project documentation is filed on an ongoing basis and the TMF is maintained in an inspection ready state
• Manages multiple projects ranging in size and complexity from single service studies, to multiple global projects within a program, with interaction from supervisor as required
• May serve as the sponsor liaison
• May proactively manage the scope, budget, and resource for their assigned projects under the guidance of an Associate Director/Director. Manages the financial aspects of the assigned projects, including ensuring projects maintain the correct level of gross profit, and changes in scope are applied as necessary. Ensures that customers are invoiced in a timely manner.
• Identify data management project issues and alert Manager (Senior Department Management) with a view to remedial action. May serve as point of escalation for individual projects.
• Ensure effective communication between departments and with Sponsor to ensure a high level of client satisfaction through successful execution of projects.
• May review Protocol, Data Management Plan, CRF and Edit Check Specifications to ensure consistency across documentation
• Ensures a review of relevant project Data Management study files for currency and accuracy, including development of a corrective action plan for quality issues or non-compliance.
• Line Management and functional support of assigned staff. Interview, onboard and train new staff as appropriate. Oversee professional development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching.
• Mentors staff in general team leadership skills, project management skills, internal Company processes, and for project specific tasks.
• Manage the resources / workload of assigned team and projects, assigns tasks to team members, manage billable and non-billable time, and subsequently monitors productivity / utilization, timeliness, and quality.
• Maintains and evaluates project progress. May work with PDMs to prepare for and attend Project Review Meetings
• May participate in Sponsor or regulatory audits
• May represent Clinical Data Management at Business Development and Sponsor-related meetings with support from the Associate Director/Director.
• May perform training for data management staff to internal and external audiences as required
• May lead or participate in process improvement/departmental strategic initiatives to support the Business. This may include the development of departmental technologies, SOPs, processes and procedures
• Maintains proficiency in Data Management systems and processes through regular training.
• Performs other work-related duties as assigned
• Bachelor’s degree, Master’s degree preferred, or RN. In lieu of Bachelor’s degree or RN, equivalent related education and experience.
• Strong project management skills
• Ability to serve in a leadership role in Data Management including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Demonstrated experience working within a team matrix structure
• Demonstrated experience in managing multiple priorities in a highly dynamic environment
• Possesses a positive attitude and works well with others
• Knowledge of ICH/GCP regulatory requirements for clinical studies
• Ability to travel as necessary (up to 25%)
This Job Excludes CO Applicants
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
:North America - USA-N-Carolina-Home-Based
:North America - US Home-Based, North America - CAN-Home-Based
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