Technology Implementation Manager
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Summary:
- Manages technology implementations within the company in collaboration with partners and sponsors, as applicable. Manages the SDLC including but not limited to the development and maintenance of the required systems, infrastructure considerations, and personnel associated with each technology project. This position will ensure both SDC-built applications and dashboards have appropriate validation documentation in place according to standard operating procedures. Works closely with all functional areas, SMEs, and stakeholders to ensure complete and accurate user requirements and successful interactions throughout each stage. This position ensures the project is delivered successfully and according to five key project management stages (Define, Plan, Execute (monitor and adjust), Complete, and Evaluate). The role contributes to the organization’s strong drive to be at the forefront of using Artificial Intelligence (AI) in clinical trials to simplify data processing and discover imperceptible correlations.
Primary Responsibilities
- Direct day-to-day assigned technology project activities, including scoping, evaluation, ROI, planning, timeline, percent complete, cost, time recorded, and SDLC tasks.
- Maintain assigned technology project plans, including estimated resourcing requirements for each project and across all assigned projects.
- Engage with various internal departments such as Data Management, Technology Solutions, Biostatistics, Statistical Programming, Project Management, IT, and Business Development to strategically align technology implementation product roadmap to business needs and strategy.
- Work with SDC executives to prioritize planned and unplanned technology implementation and maintenance of assigned projects.
- Serve as the primary point of contact on assigned technology projects and share project status, constraints and implementation solutions with SDC executives and other partner organizations, based on project details.
- Collaborate with technical and non-technical team members to ensure business needs are defined and understood and the technology implemented meets the needs and expectation of the business.
- Assess and implement systems according to a risk-based validation strategy and ensure alignment with QMS team.
- Define, with stakeholder input, technology solution onboarding and transition activities to ensure successful utilization of solution through business and/or end user adoption, including stakeholder trainings, departmental implementation plans, marketing and sales support.
- Proactively manage, communicate, and escalate risk to executives and applicable stakeholders, ensuring successful project implementation on-time and within budget.
- Develop or assist with key SDLC validation tasks to ensure project success.
- Lead key initiatives within the organization and across functions.
- Perform other related duties incidental to the work described herein.
- Adhere to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
- Comprehensive understanding of product development pertaining to clinical trial technologies, project management, client service, contracts and amendments, and key business systems
- Solid technology background in key areas of the business; wearable devices, device integrations, system integrations, GCP Biometric systems, etc.
- Good computer skills to include strong knowledge of MS Office suite of software and/or other project management software
- Successful record of accomplishment in managing a high performing team and managing without authority across functions
- Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
- Comprehensive understanding of FDA Computer System Validation requirements and agile software development life cycles
- Skilled in client service, conflict resolution, delegation, flexible team management, negotiating and resource management skills
- Ability to identify issues, and present and implement solutions efficiently and effectively
- Capability of communicating complex concepts clearly, concisely, and understandably to non-expert colleagues
- Advanced leadership, organizational and time management skills, with the ability to multi-task
- Strong interpersonal communication and presentation skills
- Able to lead a team of technical and non-technical employees to ensure project success
- Ability to develop and deliver presentations
- Ability to communicate effectively in writing and verbally
- Continuous learner with a good understanding of new GxP technology trends and ability to promote innovative solutions.
Education or Equivalent Experience
A Master’s degree in information and data science, operations research, mathematics, statistics, computer science or other related field, with focus in software development preferred, and at least eight (8) years of relevant professional experience or a Bachelor degree with ten (10) years of relevant professional experience
Why SDC
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry.
• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.
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