Manager, Clinical Programming

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Manager, Clinical programming you will serve as a key member of the Development Operations, Data Management team. You will lead Clinical Programming activities, as well as contribute to process improvement activities, business development, cross functional training, and positive customer experiences. They are also responsible for project timelines and financial results. You will assist with partnership / vendor relationship management and oversight activities while guiding the Clinical Programming team to ensure strategic alignment with overall company objectives.

Position Responsibilities / Accountabilities

• Develop and implement resourcing strategies to ensure all Clinical Programming projects are completed in a quality manner on time and within budget. This includes evaluating the quality and competency of all Clinical Programming resources (inclusive of internal and externally contracted) that are to be used on projects.
• Provide clear direction to direct reports while holding them accountable for work product quality, cross-functional communications, and overall accuracy of client deliverables.
• Explore and / or implement efficiency measures to reduce development time on EDC build efforts and data delivery programming (i.e., programming SAS edits, data cleaning, coding, and laboratory reports).
• In partnership with Quality Management, provide leadership to develop and implement Clinical Programming processes and ensure that processes and systems are aligned with corporate strategy and objectives.
• Identify activities outside the scope of contracted work, prepare cost estimates and follow scope issues through to resolution.
• Provide support to business development efforts, as necessary (i.e., Sponsor Meetings, capabilities presentations, bid defenses, conference attendance). Attend capabilities presentations, as necessary.
• Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. Act as a point of escalation as needed.
• Represent Clinical Programming on project teams either in person or through their direct reports assigned to project.
• Provide hands-on programming support, as needed or assigned, for eCRF development, edit check, listing, reporting and data displays.
• Advise clients on best practices for clinical database builds, eCRF layout, and compliance with CDISC standards.
• Manage scheduling and time constraints across multiple projects and multiple locations communicating timelines via MS project or other tool input.
• Conduct a post-trial analysis to identify efficiency opportunities that can improve overall data accuracy as recommendations to Management for consideration.
• Work collaboratively with other functional leaders in the design of new and enhanced biometric tools.
• Ensure that all staff continually maintain the established training requirements for the defined Clinical Programming team according to Catalyst SOPs, Job Aids, and templates.
• Responsible for the management of external vendors providing programming services.
• Participate in the interviewing and hiring process of Biometrics candidates as required for projects according to client needs.

Responsible for administrative management of assigned staff (approve / track time-off requests, review timesheets / expense reports, ensure staff is compliant with required trainings, etc.).

Managerial Requirements / Responsibilities

Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching / performance management, goal setting, & salary.

Position Qualifications / Requirements

Education : Education : 4-year computer science / math degree or equivalent required; master's degree preferred.

Experience

Required Certifications : N / A

Required Skills

Skills Required

Coding, cdisc standards , Sas, Data Cleaning, Microsoft Office Suite