Responsibilities:
Participating in project overview meetings and the development of export design specifications
Leading the development of export designs by providing expertise in organizational capabilities and best practices
Consulting with clients and internal personnel relating to export design best practices
Consulting with clients, auditors and internal personnel relating to study specific export matters.
Communicating export design needs to the appropriate personnel
Maintaining and educating staff on FAQ’s, best practices, capabilities, pitfalls and design flaws in various export designs and requests
Assigning projects among staff taking into consideration staff skill set and workload
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
Managing group initiatives/special projects
Implementing and managing the introduction of new technology and departmental tools
Keeping department head advised of current issues
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 Programming processes and responsibilities
Contributes to overall company communication, cooperation and efficiencies by:
Communicating group updates to appropriate personnel throughout company
Working with the management team to streamline processes
Always considering the impact of Clinical Data Programming’s processes, productivity and communication on other departments and the company as a whole when implementing and managing processes
Frequently interacting with other departmental supervisors and managers to keep abreast of their respective environments (i.e., 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 group standards
Contributing to Clinical Data Management procedural manual(s)
Reviewing and updating company SOPs related to CDM department
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
What we look for:
Bachelor’s degree computer science, life sciences or related field preferred
3 + years of team management experience within clinical data programming
5+ years experience as a SAS programmer, including use of the SAS Macro facility
Previous data management experience in pharmaceutical research and development required
5+ years clinical trials experience within a CRO or pharmaceutical research organization (preferably in a SAS programmer position)
Working knowledge of GCP, ICH guidelines and FDA regulations
Working knowledge of other clinical trial data management tools such as ClinTrial, Oracle Clinical, etc.
Experience working with computer software including Word, Excel and Access preferred
Ability to work in group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
Clario generates the richest clinical evidence by fusing our deep scientific expertise and global scale into the broadest endpoint technology platform. By doing this, we empower our partners to transform lives. Driven by purpose We are a seasoned clinical trial data management company driven by our purpose to transform lives by unlocking better evidence. We apply scientific expertise to our technology and deploy it globally, unlocking the richest clinical evidence to reduce disease, improve health and transform the lives of patients and their families.
Experience With almost 50 years of experience as a clinical trial data management company and 19,000 clinical trials, we have mastered the ability to collect the richest clinical evidence. Reliability and precision Through science-informed technology, we generate reliable and precise clinical evidence, regardless of trial location or evidence generating modality. Proven global scale Our global infrastructure has supported regulatory compliance in over 120 countries. With demand & inventory planning, device provisioning and logistics and 24/7 customer care, no one can scale the way we can.