Sr. Director, Project Management & Clinical Affairs - Remote US

Sarah Cannon Research InstituteNashville, TN
8dRemote

About The Position

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. 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. 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.

Requirements

  • 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
  • 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

Responsibilities

  • 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
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