Sr. Director, Project Management & Clinical Affairs - Remote

Position: Sr. Director, Project Management & Clinical Affairs - Remote US
This position will provide strategic leadership to meet timelines and quality standards, support new and repeat business, and collaborate across Development Innovations and Sarah Cannon to drive departmental growth. The role includes supervising, training, and mentoring Project Management and Clinical Affairs staff, as well as improving cross-functional processes.

Additionally, the
** Senior Director
** manages departmental budgets, forecasting, and financial performance, while developing policies and procedures that uphold Sarah Cannon’s mission to improve patient outcomes and advance medical science through high-quality clinical research execution.
*** This is a remote position based in the US with up to 20% travel annually; relocation assistance and visa sponsorship are not available.
***** Responsibilities of this role will include and are not limited to:
*** Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs; develop and update SOPs and processes as needed.
* Monitor evolving regulatory requirements (e.g., ICH‑GCP, FDA, EMA) and update departmental practices to maintain alignment with current industry standards.
* Establish and lead the clinical operations strategy, setting departmental goals and driving initiatives that support organizational objectives and a culture of accountability and continuous improvement.
* Lead the evaluation and implementation of new technologies, tools, and methodologies to enhance clinical monitoring, site start‑up, and operational efficiency.
* Oversee change management efforts related to new processes, systems, or organizational structures, ensuring effective communication, staff engagement, and smooth adoption.
* Promote strong cross‑functional collaboration with internal stakeholders (data management, regulatory, medical affairs, IT) and external partners (vendors, CROs, investigator sites) to enable seamless operational execution.
* Other duties as assigned
** Qualifications and experiences needed for success include:
*** Bachelor Degree required, Master's Degree highly preferred
* 10+ years' extensive work experience in clinical research, clinical affairs, project management including prior work experience as a CRA line manager
* Extensive experience in RBM (Risk-based Monitoring)
* CRO and Oncology experience required
* Prior experience should include minimum 2 years as a Director
*** Important skills and expertise should include:
**** Project Management, collaboration with external partners, vendors, CROs
* Regulatory Compliance expertise
* Leadership and team building
* Thorough expertise in GCP, FDA, EMA, other regulatory guidelines
* Familiarity with data collection, handling, QA processes, including EDC and HIPAA
* Familiarity with auditing processes, CAPA, and continuous improvement methodologies
* Awareness of new technologies impacting clinical research such as decentralized trials, telemedicine, and AI
* Decision-making and change management
* Establishing operational optimization
* Exceptional customer service attitude
* Presentation and negotiation skills
* Strategic thinking, enterprise mindset, innovation and futuristic thinking

Qualifications and experiences needed for success include:

Our
** Senior Director Project Management and Clinical Affairs
** is a key leader overseeing daily operations and strategic direction for the Project Management and Clinical Affairs departments, with a strong focus on clinical operations. This role manages and develops clinical team leads and ensures effective clinical monitoring and site start-up. The
** Senior Director
** ensures compliance and successful delivery of contracted services for Industry and Investigator Initiated Trials.

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and…