Director, Clinical Research Solutions

Digital Infuzion•Rockville, MD

About The Position

At Digital Infuzion, we believe that by equipping researchers with rapid insights and providers with tailored, on-demand data, we can help people lead better, healthier lives. We harness innovative health-IT solutions and advanced bioinformatics to make meaningful impacts in patient care. Our culture is creative, open, and growth-oriented, guided by core values that shape how we lead and deliver: Outcomes First – Focus on what matters most and makes timely, informed decisions. Innovative – Embrace creativity and continuous improvement to drive novel solutions. Radical Candor – Communicate openly and honestly, balancing direct feedback with genuine care. Never Satisfied – Pursue excellence and growth beyond the status quo. Resilient – Adapt and persevere through challenges, turning obstacles into opportunities. If you are passionate about leveraging technology to advance healthcare and thrive in a collaborative, mission-driven environment, this may be the opportunity for you. Position Summary The Project Director, Clinical Research Solutions serves as the senior leader responsible for the successful execution of a strategic clinical research support program for the National Institute on Aging (NIA). This role provides scientific, operational, and programmatic leadership for a multidisciplinary team delivering comprehensive project management, regulatory oversight, data and safety monitoring coordination, analytics, and recruitment support for Alzheimer’s disease and aging-related studies. The Project Director drives strategic alignment between NIA’s research mission and Digital Infuzion’s delivery excellence—driving quality, compliance, and innovation across all clinical research support functions. This includes oversight of the Data and Safety Monitoring Board (DSMB) and Observational Study Monitoring Board (OSMB) operations, stewardship of CROMS (Clinical Research Operations and Management System) data integrity, and advancement of inclusive recruitment strategies for underrepresented populations in clinical research. This leadership role directly contributes to NIA’s mission to improve the health and well-being of older adults through innovative, inclusive, and high-quality clinical research. Reporting directly to the Vice President of Operations, Client Delivery Services, the Project Director collaborates with Practice Area Leads, Technical Operations leadership, and cross-functional teams to ensure excellence in execution, financial performance, and client satisfaction while driving innovation across the health-research ecosystem.

Requirements

Master’s or Doctoral degree in health, life sciences field
10 + years’ experience managing complex, large-scale projects or programs within the federal government, healthcare, or life-sciences sectors.
Provide strategic direction and oversight for successful delivery of multiple related projects (time, cost, quality).
Proven ability to oversee multiple related initiatives (development, research, or service delivery).
Strong financial acumen with experience managing contracts, budgets, and resources.
Exceptional presentation, communication, and interpersonal skills.
Strong analytical, problem-solving, and strategic-thinking abilities.
Ability to translate complex scientific and operational processes into actionable delivery plans.

Nice To Haves

Doctoral degree (PhD, DrPH, MD, PharmD, or DSc) in a biomedical, clinical, or health-related field.
Acceptable Alternative: Master’s degree (MPH, MS, MHA, or MBA) with significant clinical research management experience.
10–12 years of progressively responsible experience in clinical research administration, operations, or program management.
Preferred: 15+ years of progressive experience, including at least 5 years in senior leadership roles overseeing large, federally funded clinical research programs.
Proven experience supporting or managing Data and Safety Monitoring Boards (DSMBs) or similar oversight committees, with a strong understanding of the clinical trial lifecycle and study operations.
PMP certification or equivalent project/program management credential.
Demonstrated experience managing or collaborating with external partners, grantees, vendors, or stakeholders in a research or technical environment.
Familiarity with Agile, Scrum, or hybrid project-management frameworks.

Responsibilities

Serve as the primary contact and strategic partner between the sponsor and the organization.
Leverage scientific and/or clinical subject-matter expertise to strengthen decision-making, enhance delivery quality, and reinforce Digital Infuzion’s status as a trusted research and health-innovation partner.
Build strategic partnerships across teams and stakeholders to drive alignment and integrated delivery. Trusted advisor to NIA leadership, known for proactive engagement, clear communication, and consistent delivery of strategic value—positioning Digital Infuzion as a long-term partner in advancing the Institute’s mission
Lead project planning, execution, and delivery, ensuring adherence to standards and procedures.
Establish, communicate, and manage customer expectations with transparency and accountability.
Drives financial stewardship and operational efficiency, proactively managing budgets, contracts, and scope alignment.
Drive proactive risk identification, issue management, and resolution.
Champions a culture of compliance and quality, ensuring all activities align with SOPs, ICH-GCP, regulatory, and contract-specific requirements.
Leads a multidisciplinary team spanning clinical operations, data management, and analytics functions.
Leverages coaching, recognition, and professional development to sustain a high-performing, mission-aligned team.
Provide enterprise-level oversight across a portfolio of clinical research and data-driven initiatives, ensuring alignment with organizational strategy and client priorities.
Reinforces stakeholder trust by translating complex program performance into clear, actionable insights and demonstrated results
Lead governance and performance management efforts — driving standardization, transparency, and best practices across projects.
Empowers and develops emerging leaders, fostering a culture of ownership, accountability, and continuous learning that drives delivery excellence and client satisfaction.
Partner with senior leadership to translate portfolio insights into strategic direction and operational priorities.
Serve as a thought leader and internal SME, contributing to white papers, strategic proposals, and business development initiatives.
Identify and advance opportunities for innovation, growth, and cross-program synergy within the Clinical Research Solutions portfolio.
Applies digital health innovation, AI, and data-driven strategies to enhance clinical trial oversight and participant engagement.
Leverages coaching, recognition, and professional development to sustain a high-performing, mission-aligned team.
Support the adoption of AI and advanced analytics tools to enhance project visibility and performance insights.
Champions process innovation and continuous improvement initiatives that elevate performance, quality, and scalability.
Drives innovation in project and program management through digital transformation, automation, and data-driven insight.
Champion knowledge sharing and continuous learning across teams.