Manager Clinical Programming
Our client is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs - and into the priorities and concerns of the medical specialists who treat them.
The position is responsible for:
- Management and oversight of a clinical programming team and external vendors.
- Execution of the clinical programming operations against project timelines, and any other priorities.
- Identification and implementation management of defined department metrics as a framework for timely and quality of clinical programming deliverables.
- Collaboration with management within and outside the GDO organization.
Clinical Programmer: Responsible for the role which includes document creation, development, peer review, validation, and maintenance of database systems and tools to support clinical research activities. Provide leadership and content expertise for programming activities from startup through the statistical analysis stage of clinical studies in support of Global Development Operations to effectively manage data capture, review and database lock activities.
Data Integration Programmer: Responsible for the role which includes integration, aggregation, delivery, and creation of technical documentation including the Data Lineage Plan of clinical study data. Peer review of deliverables. Main technical interface with the External Data Providers. Creation of industry standard compliant Data Tabulation Datasets (e.g., CDISC SDTM).
Global Librarian: Responsible for the role which includes maintenance of Global Libraries and ensuring their synchronization with department standards (e.g. Standard Data Elements). Review and approval of new programming objects prior to their use for study database set-up.
Line Function Manager: Responsible for the role which includes planning, organization, and management of all internal and external programming activities supporting clinical trials. Hire, train and manage performance of staff inclusive of orientation, training, personal development, completing and administering performance evaluations). Works closely with human resources and temporary staffing agency (e.g., ADECCO) to ensure timely hiring of qualified resources.
Line Function Lead: Responsible for the role which includes developing procedures and documentation in support of the definition of, and project planning and requirements for study-specific program and software development.
Vendor Selection and Management Team Member: Responsible for the role which includes participating in the vendor selection process and managing the vendor in accordance with the approved Vendor Management Oversight Plan. Assessment/Re-assessment of Vendor capabilities, as necessary.
Subject Matter Expert: Responsible for the role which includes participation in the identification, evaluation, recommendation, implementation and management of Clinical Information technology solutions to support Clinical study database activities including all forms of electronic data capture through in-house or third party vendors. Contribute to standardization of data capture, processing and reporting through traditional and innovative electronic solutions. Support Corrective Action and Preventive Action initiatives. Report process gaps and potential misconduct during clinical studies to management.
Desired Skills & Experience
- Degree or equivalent experience in Computer Science, Life Science or related field: BS/BA degree with 9 years experience, or MS degree with 7 years experience, or PhD degree with 4 years experience.
- Minimum 4 years experience in a leadership role within a clinical programming organization, preferably within medium-large pharma or CRO.
- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies
- Knowledge of clinical Data Management and Clinical Programming methodologies as well as current and emerging global industry standards.
- Working knowledge of global standards related to clinical study data management activities (CRF design, data standards (CDISC; SDTM), database design, coding and coding dictionaries, etc.).
- Ability to effectively interact with and influence others without direct reporting relationships
- Technical abilities and skills in the analysis, design, specification and programming of computer systems using tools such as Powercenter, SAS. Knowledge of UNIX, Oracle a plus.
- Technical writing skills and experience
- Analytical, problem solving and technical skills
- Planning, organizational, and project management skills
- Negotiation skills
- Conflict management skills
- Attention to detail with high quality outputs
- Computer skills (MS Office; word processing, spreadsheets, graphics, PowerPoint)
- Ability to travel 15%