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Manager, Study Operations - Operations Readiness Team

Role overview

Qualifications

  • Bachelor's degree in nursing, health administration, or other related field
  • CITI GCP training
  • Knowledge of GCP and applicable federal clinical research regulations in the United States
  • 5+ years of experience in clinical research operations, healthcare operations, or site management, including direct people leadership

Responsibilities

  • Build, lead, and continuously develop a deployable team of operational readiness specialists
  • Assign and manage team deployments based on site need, launch calendar, and risk signals
  • Establish training curricula, checklists, and standard operating procedures for onboarding new sites
  • Own the operational readiness plan for new site launches, coordinating staffing, workflow setup, and training

Key facts

Hard skills

Other skills

  • Leadership
  • Quality Assurance
  • Communication
  • Team Building
  • Problem Solving
  • Time Management

About the company

The START Center for Cancer Research logo

The START Center for Cancer Research

Biotechnology

Deeply rooted in community oncology centers globally, the START Center for Cancer Research ("START") provides patients with access to specialized Phase 1 clinical trials for novel anti-cancer agents. With research sites in the United States and in Spain, Portugal, and Ireland, START’s clinical trial sites have conducted more than 1,300 early phase clinical trials, including for 45 therapies that have gained FDA/EMA approval. Founded in Texas in 2007, START today boasts 25 Principal Investigators (PIs) across its worldwide clinical trial sites. With over 100,000+ square feet of world-class research facilities, START offers patients comprehensive treatment plans that include multi-specialty services, genetic profiling of tumors, targeted therapies, state-of-the-art treatment technology, and advanced access to clinical research options. START is committed to accelerating passage from trials to treatments, and to delivering hope to patients, families, and physicians around the world.

Company details

IndustryBiotechnology
Company size201 - 500

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Job description

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe.   

Position Summary

The Manager, Study Operations leads START's Operational Readiness Team, a deployable, cross-functional team that prepares new clinical research sites to launch and intervenes when existing sites show signs of instability. This role builds and leads a bench of operational specialists who can be deployed into key roles across the operating model, including CRC, DC, Infusion Nursing, Scheduling, Clinical Administrative Assistant, Patient Navigation, IDS, and PK, to close gaps, transfer best practice, and stand up sustainable operations quickly. This role also serves as a direct extension of the VP, Regional Operations across the site network, surfacing risk before it becomes a crisis and acting as the first line of defense when a clinic shows signs of operational strain. By accelerating new site readiness and stabilizing at-risk clinics, this role directly enables START's site growth and expansion targets.

Essential Responsibilities

  • Build, lead, and continuously develop a deployable team of operational readiness specialists who can flex across key roles, including CRC, DC, Infusion Nursing, Scheduling, Clinical Administrative Assistant, Patient Navigation, IDS, and PK.
  • Assign and manage team deployments based on site need, launch calendar, and risk signals, balancing new site readiness work against active stabilization support.
  • Establish training curricula, checklists, and standard operating procedures the team uses to onboard new sites and remediate struggling ones consistently.
  • Own the operational readiness plan for new site launches, coordinating staffing ramp, workflow setup, systems onboarding, and role specific training ahead of first patient activity.
  • Partner with site leadership to validate that staffing models, space planning, and department workflows meet readiness standards prior to go live, supporting START's site growth and expansion targets.
  • Proactively identify and escalate emerging operational, staffing, quality, and safety risks across the site network to the VP, Regional Operations.
  • Maintain a standing view of site health across the network, including staffing ratios, data timeliness, quality and safety indicators, and patient volume trends, to flag sites trending toward instability before they require crisis intervention.
  • Act as first responder when a site shows signs of instability, such as a leadership vacancy, staffing shortfall, quality or safety concern, or rapid volume ramp, deploying the readiness team to stabilize operations.
  • Diagnose root causes of site underperformance and implement corrective action plans in partnership with site and department leadership.
  • Determine when a site has stabilized and can transition off direct readiness team support.
  • Serve as a comfortable, trusted point of contact for Principal Investigators during new site launches and site stabilizations, fielding provider questions or concerns and routing them to resolution.
  • Partner with the Global Training Manager and network training facilitators to align readiness team training content with enterprise training standards and curricula.
  • Coordinate with Integration Leadership on new site and acquisition integration timelines, ensuring readiness team deployment is sequenced with broader integration milestones.
  • Partner with Quality Assurance and Compliance leadership to proactively identify and mitigate site level risk, operating with a high degree of autonomy and minimal oversight.
  • Incorporate QA and compliance standards into readiness team training, checklists, and stabilization playbooks so sites launch and recover audit ready.
  • Other duties may be assigned at any time.

Required Education and Experience

  • Bachelor's degree in nursing, health administration, or other related field.
  • CITI GCP training.
  • Knowledge of GCP and applicable federal clinical research regulations in the United States.
  • 5+ years of experience in clinical research operations, healthcare operations, or site management, including direct people leadership.
  • Must be familiar with Microsoft Office applications and clinical documentation systems.

Preferred Education and Experience

  • Master's degree in health administration, nursing, or other related field.
  • Experience leading or standing up teams or departments in an oncology clinical research setting, including new site launches or site turnarounds.
  • Specialty certification in research or an associated field.
  • Demonstrated involvement in professional practice and industry advancement, such as conference attendance, poster presentations, or conference presenter or coordinator roles.
  • BLS certification.

Physical and Travel Requirements

  • Approximately 50% travel, including extended stays to support new site launches and site stabilizations.
  • Very fast paced and ever changing healthcare environment.
  • Demanding deadlines and time frames.
  • Constant demand for updating knowledge.
  • Works closely with Principal Investigators, physicians, and ancillary personnel across multiple sites during launches and stabilizations.

Best-in-Class Benefits and Perks  

We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:  

  • 401(k) retirement savings plan with employer match  
  • Eligibility for an annual performance bonus, based on role and company results  
  • Generous paid time off and paid holidays  
  • Comprehensive medical, dental, and vision coverage and optional insurance options  
  • Company paid life and disability insurance for added financial protection  
  • Employee Assistance Program (EAP) providing confidential, no ‑cost support for you and your family from day one  
  • Flexible FSA and HSA plans to support your financial wellness  
  • Commitment to a supportive environment that values balance, wellbeing, and flexibility  
  • We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.  

More About START  

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites.

Learn more at STARTresearch.com.   

Ready to be part of a team changing the future of cancer treatment?  

Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.  

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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