Description

Welcome! At Digital Infuzion, we believe people can lead better, healthier lives. To do so, researchers need insights faster, and providers need on-demand data and tailored software solutions. Which is why we are passionate about developing innovative products for the healthcare industry so researchers and providers can better serve their patients. We go beyond ordinary health IT services because we see the advancement of technology and bioinformatics as opportunities to make meaningful impacts in patient’s lives. If you love the idea of working in a creative, open, and growth-oriented environment all while helping people live healthier lives, then keep scrolling - we may have just the opportunity for you. 

We are currently seeking an accomplished Program Manager to lead an enterprise software development program within the dynamic field of clinical research. This role demands an adept professional with a proven ability to navigate challenges, resolve conflicts, and cultivate positive relationships. The successful candidate will exhibit exceptional business acumen and possess keen emotional intelligence, enabling them to adeptly navigate complex situations while fostering collaborative partnerships.

As the primary point of contact for our valued customers, the Program Manager will play a pivotal role in the overall management, integration, and coordination of all program activities outlined in the contract. This includes overseeing contract terms and conditions, providing meticulous oversight, and effectively coordinating budgetary and staffing requirements. Collaborating closely with the team, the Program Manager will ensure the successful delivery of all project milestones, while prioritizing client satisfaction.

Responsibilities

Program and Contract Management:

• Serve as the primary contract representative, responsible for managing all aspects of the program, including project planning, development, and implementation in alignment with cost, schedule, and technical requirements.
• Provide overall direction for all program activities in adherence to industry best practices, including PMI standards.
• Ensure that activities are executed efficiently, following established methodologies, and in alignment with organizational program management standards.
• Organize, direct, and manage all aspects of contract operational support functions involving multiple complex and inter-related project tasks that may require managing teams of contractor personnel at multiple locations.
• Consult with customer and contractor personnel to formulate and review task plans and deliverables, ensuring conformance with program and project task schedules, costs, and contractual obligations.

Clinical Research Expertise:

• Exhibit a proven track record of successfully implementing and managing clinical research projects.
• Demonstrate an in-depth understanding of the clinical research domain, staying abreast of industry trends, regulations, and best practices, including those outlined by organizations such as the National Institutes of Health (NIH). 
• Leverage comprehensive knowledge to actively guide and contribute to strategic decision-making throughout the lifecycle of clinical research projects, ensure alignment with NIH guidelines and standards. 
• Demonstrate hands-on experience in navigating regulatory requirements and overseeing projects in accordance with industry and NIH protocols.
• Remain current and participate in continuing education and training opportunities related to clinical informatics. 

Communication and Collaboration:

• Facilitate effective communication and collaboration.
• Lead a cross-functional, cohesive team of clinical, technical, and administrative subject matter experts.
• Collaborate with senior management and customers to understand business goals and the system's vision, fostering effective communication and collaborative decision-making.
• Manage and maintain interfaces with senior levels of the customer’s organization, actively engaging in relationship management to ensure alignment with project objectives.

Budget Tracking and Procurement:

• Implement effective tracking mechanisms to monitor project cost, schedule, and performance, promptly identifying and addressing any variances.
• Develop procedures and status reports to ensure accurate and complete documentation of project activities.
• Establish and maintain technical and financial reports, demonstrating project progress to both management and customers. Ensure these reports align with project goals, providing clear and effective communication with stakeholders.
• Demonstrate experience in the procurement and tracking of Other Direct Costs (ODCs).
• Implement robust systems within project budgets to ensure transparency and accountability in financial management.

Requirements

• Bachelor’s degree in Computer Science, or Information System, or Life Sciences or Biology or a suitable combination of education, training, and experience.
• 15 years of expertise in the clinical research informatics domain, demonstrating knowledge of clinical research processes and informatics needs.
• 12 years of experience managing large-scale health or research-related software development/IT programs with federal government clients.
• Experience managing Cost Plus Fixed Fee, Firm Fixed Price, and Time and Materials contracts and demonstrating the ability to deliver on schedule and within budget.
• Proven track record in successfully leading high-visibility, high-impact programs, including responsiveness to customer inquiries, emails, and requests.
• Detail-oriented, superior communication skills, both oral and written, coupled with strong problem-solving and analytical abilities, as well as excellent technical writing and presentation skills.

Preferred Skills and Experience 

• Master’s degree in health/life/information sciences or a scientific discipline.
• PMP certification or other project/program management certification.
• In-depth knowledge of best practices methodology for project execution and monitoring, ensuring on-time, on-budget delivery (e.g., PMBOK).
• Proficiency in software quality assurance, validation, and adherence to industry standards (e.g., CMMI).
• Familiarity with 21 CFR Part 11 and Good Clinical Practices.

Digital Infuzion, Inc. is an Equal Opportunity Employer. EOE/AA/M/F/D/V 

It is the policy of Digital Infuzion, Inc. to provide equal employment opportunities without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, genetic information, or any other protected characteristic under applicable law.