Clinical Operations Systems Lead

We offer an excellent salary, bonus and benefit package, including medical and dental coverage, life insurance, disability, retirement plans, paid holidays and vacations, & flexible work options. Our field sales positions offer a company car & a sales incentive plan which ranks above the competition. TAP is the place you want to be.TAP is an Equal Opportunity Employer.The Clinical Operations function within the Clinical Operations and Scientific Data Analysis Department is responsible for the planning and execution of clinical programs for TAP Research and Development (R&D). The Clinical Operations department interacts with all R&D departments including Therapeutic Area Heads, Medical, Regulatory, Scientific Affairs, Statistics, Data Management, Outsourcing, and Pharmacovigilence. It also interacts with other departments outside of R&D (i.e. Quality Assurance).The COSL leads the strategic planning and successful implementation of electronic systems within Clinical Operations, (e.g., the Clinical Trials Management System (CTMS)). The COSL is responsible for establishing and controlling business standards, documentation, application authorization, and PPGs (Policies, Procedures, Work Instructions) related to one or more CO systems. The COSL ensures development and conduct of appropriate and timely training to Clinical Operations and other R&D personnel having access to CO systems. The COSL will also supervise and/or direct the activities of CO Systems personnel for the completion of these responsibilities.Systems Management
Coordinate with CO management and IS to strategically develop goals and detailed project plans for CO systems and applications.
Serve as the primary business liaison with IS for designated Clinical Operations (CO) electronic systems.
Authorize and certify user account access to Clinical Operations electronic systems.
Develop and implement a quality management system for CO clinical trial management system data and activities to ensure all data is reliable, accurate, unique and consistent.
Coordinate with IS to conduct validation assessments for CO electronic systems.
Manage changes to CO electronic systems
Implement system improvement/upgrades.
Develop technical solutions to urgent Clinical Operations management requirements. Coordinate with CO management to determine the term of the requirement and work with IS to develop and implement a long-term solution if necessary.
Establish and maintain policies, procedures and work instructions (PPGs) for the use of Clinical Operations electronic systems.Personnel Management
Manage CO Systems personnel, including but not limited to participating in the selection, training, project assignment, supervision, and performance feedback process.
Monitor resource utilization and provide work status to the department manager and other TAP management as needed.Operations Management
Oversee the request and deployment of computer hardware and software for new and existing home office and remote Clinical Operations personnel.
Coordinate with CO management to maintain current profiles for hardware, software, and account requirements for each CO functional role.
Monitor computer performance issues, and communicate trends and systemic problems to IS.Training
Conduct needs analysis and evaluation of core competency levels for use of CO computer systems and software related to conduct of business management activities.
Plan, develop and implement training initiatives, including classes, seminars, and tutorials to train Clinical Operations staff.
Provide CO with technical support for computer-interactive training initiatives and meetings (i.e., department meetings, investigator meetings).Qualifications
With a Bachelor's degree:
6+ years experience in computer systems/ information technology required.
4+ years of development and management of computer systems/applications required
2+ years of managerial/supervisory experience required
2+ years of clinical research, pharmaceutical, medical, or related life sciences experience highly desired
Presentation skills and training experience required.With an Associate's degree:
8+ years experience in computer systems/ information technology required.
4+ years of development and management of computer systems/applications required
2+ years of managerial/supervisory experience required
2+ years of clinical research, pharmaceutical, medical, or related life sciences experience highly desired
Presentation skills and training experience required.With a high school diploma:
10+ years of experience or education related to computer systems/information technology is required
4+ years of development and management of computer systems/applications required
2+ years of managerial/supervisory experience required
2+ years of clinical research, pharmaceutical, medical, or related life sciences experience highly desired
Presentation skills and training experience required.Sufficient knowledge of computer systems, networking, programming, and applications to be able to be the principal liaison between CO and IS. Sufficient knowledge of software validation procedures to ensure proper procedures are being implemented. Excellent oral and written communication skills. This person must speak, read and write in English fluently. Expertise with MS Office and Desktop software. Understanding of clinical research GCP regulations, processes and procedures desired.
REQUIREMENTS
Computer systems and information technology