Director RTSM Operational Excellence - United States
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- Our company is looking for intelligent, creative and dedicated professionals to join our growing team.
- We are a company that values technical excellence, teamwork and a commitment to success.
- We employ cutting edge technology to provide our customers with industry leading solutions and are currently seeking to fill the position of Director RTSM Operational Excellence.
- This can be a remote based position.
- The Director, RTSM Operational Excellence is responsible for developing and maintaining all RTSM-related documentation including but not limited to policies, procedures (SOPs), work instructions (WIs) and training manuals.
- The Director RTSM-OE works closely with other RTSM department heads to improve operational and organizational performance and quality through development of optimized and fit for purpose work product and impactful training programs.
Developing policies, procedures, processes and tools that support efficient implementation and maintenance of RTSM studies through continual collaboration and communication with business stakeholders both within RTSM (delivery, commercialization) and outside RTSM (product development/management and business development)
- Develop study implementation and maintenance processes, SOPs, WIs (scoping, collaboration, creation)
- Reducing the amount of paperwork and back and forth necessary to design, build and deploy studies
- Implement principals of quality by design
- Maintenance and continuous improvement of processes, SOPs and WIs
- Recommending innovative approaches
- Incorporating Voice of the Customer (VOC) into processes and best practices
- Infusing latest industry trends and methodologies in the RTSM space
- Updating policies/procedures based on CAPAs
- Ensuring technical teams are contributing to continued expansion of our service delivery models
- Development of RTSM operating best practices
- Ensuring an infrastructure is in place to develop, maintain and enforce regulated and non-regulated company policies and procedures for RTSM operations, and that training materials are up to date, impactful and high quality:
- Collaborate and interface with Quality Assurance and the QMS
- Assure proper change management activities are followed for all RTSM documentation (policies, procedures, WIs, guides, training materials, etc.)
- Ensuring RTSM staff are prepared to meet the needs of the RTSM delivery model:
- Interface with Learning and Development as needed for training development and compliance
- Hiring and developing team members to support the documentation requirements of the business
- Communicating and enforcing company standards and best practices
- Travel:up to 25%
- Lifting: 0-20 lbs
- Other: Computer work for long periods of time
- Bachelor’s degree required, MBA preferred
Additional skill set:
- Goal oriented
- 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
- 10+ years working in an eClinical environment
- 5+ years of technical transfer experience with relevant eClinical technologies
- Understanding of medical and/or clinical trial terminology required
- Proven ability in analyzing data
- Experience working with computer software including Word, Excel and Access preferred
- 10+ years’ experience working with clinical trials and/or within pharmaceutical environment, preferred