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Associate Director, Clinical Operations (Observational Studies Unit)



Chicago, IL, USA
Posted on Saturday, October 28, 2023

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Responsible for the planning and implementation of clinical project management deliverables of assigned project(s) to ensure delivery within specified budgets and timelines and in accordance with applicable regulatory guidelines/requirements, Tempus Compass Standard Operating Procedures (SOPs) and project specific instructions. Manage and contribute to continuous process and quality improvement within the Clinical Operations Observational Studies Unit.

Independently serves as Strategic Oversight (as assigned) on observational studies, applying and providing guidance to clients and team members on best practices tailored to the applicable project, patient population, study aims and client. Responsible for coaching/mentoring and supporting the Clinical Study Manager team. Expected to build positive rapport with the internal and external project teams and site staff.

Serves in a line management and leadership role with minimal supervision and guidance.

Job Responsibilities:

Tasks may include but are not limited to:

Lead/Perform independently, with minimal guidance and oversight:

  • Provide strategic oversight for (a portfolio of) projects as assigned
  • Line manage Clinical Operations Observational Studies Unit personnel (including interviewing and selection, terminations, professional development and performance appraisals) • Provide operational oversight of department deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency and quality • Contribute to development and review of department-level Standard Operating Procedures, Work Instructions and other guidance documents
  • Identify and manage implementation of unit level initiatives, growth and training needs • Oversee Observational Studies Unit deliverables including timeline, quality, scope, and financials • Monitor resource allocation and ensure that services are being delivered with quality and efficiency • Proactively identify risks and escalate to Clinical Operations Director and other appropriate functional leads
  • Perform other duties as assigned
  • May involve overnight travel

Demonstration of Tempus Compass Values:

Consistently strives to demonstrate the following Tempus Compass values:

  • Recognizes that the team is always stronger than the individual
  • Seeks to inspire others by demonstrating consistently strong performance
  • Treats people with respect regardless of role or point of view
  • Listens well and seek to understand before reacting
  • Provides candid, helpful and timely feedback to colleagues
  • Demonstrates curiosity about and contributes effectively to areas outside of their specialty • Keeps the bigger picture in mind when making decisions
  • Never stops learning
  • Questions assumptions and offers suggestions for improvement
  • Focuses on results rather than process and seeks to minimize complexity when process is required • Identifies and addresses root causes, not symptoms
  • Demonstrates poise in stressful situations
  • Strives to always do the right thing
  • Questions actions that are incongruent with Tempus Compass values

Minimum Qualifications:

  • University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution • Minimum of thirteen (13) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
  • Minimum of ten (10) years Clinical Trial Lead/Manager or Clinical Project Manager or relevant clinical operations experience at a CRO, biotech or pharma company
  • Experience with observational/non-interventional studies, registries, comparative effectiveness studies, etc.
  • Familiar with concepts commonly incorporated non-therapeutic studies: risk-based monitoring, quality of life and patient-reported outcomes, health outcomes etc.
  • Effective at integrating global clinical operations teams and leading them through challenging and complex situations
  • Experience overseeing a program or portfolio of projects
  • Excellent communication, planning, decision-making, risk management, negotiation, conflict management and time management skills.
  • Experience in the full study life-cycle
  • Experience presenting and negotiating with senior internal and client leadership • In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
  • Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
  • Demonstrated ability to handle multiple competing priorities and to utilize resources effectively • Demonstrated ability to build rapport with team members and clients; customer-service oriented • Excellent written and verbal communication skills
  • Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines
  • Able to proactively anticipate needs and follow through on all assigned tasks • Proficient in Microsoft Word and Excel

Preferred Qualifications:

  • Prior experience working for both a Sponsor company and a CRO
  • Prior experience in a Clinical Research Associate related role at a CRO, biotech or pharma company
  • Prior experience working on global clinical trials
  • Direct line management experience
  • Leadership position experience
  • Working understanding of the drug development life-cycle within oncology products • Familiarity with the molecular biology of cancer including genomics, proteomics, and immunology

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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.