Frequently Asked Questions About Choice ClinOps
Choice ClinOps provides sponsor-embedded, fractional executive clinical operations to small- and mid-size local and global sponsors of first-in-human, Phase 1, and Phase 2 oncology, rare disease, and cell and gene therapy trials. We are not a CRO, not a staffing company, and not a consulting firm.
Understanding Fractional Clinical Operations
Fractional clinical operations leadership places an experienced, sponsor-side clinical operations executive inside a sponsor's team on a fraction of the time of a full-time employee (part-time basis), providing senior governance, oversight, and execution without the cost of a full-time or permanent hire. The executive is embedded in the sponsor organization — attending leadership meetings, owning decisions, and directing vendors — rather than delivering recommendations from the outside. It is designed for lean teams whose portfolio complexity has outgrown their internal senior operating capacity.
A fractional clinical operations executive is a senior clinical operations leader who works for a sponsor company part-time, at the level of a VP or Head of Clinical Operations, for a fraction of the time and cost of a permanent hire. At Choice ClinOps, every fractional executive has 20+ years of hands-on clinical operations experience across sponsor, CRO, and/or site environments. They step in to lead, not to advise.
A sponsor should bring in fractional clinical operations support during study planning phases preventing the need for rushed assistance if control of the study is lost. Choice ClinOps fractional clinical operations team members also often asked to join sponsor teams when clinical study timelines are slipping, CRO or vendor oversight is thin, enrollment is underperforming, or a major transition such as a merger, acquisition, CRO change, portfolio shift, or new study threatens continuity. It is also the right move when a lean team needs executive-level ClinOps judgment but cannot justify — or cannot yet find — a full-time senior hire. The earlier the engagement, the more optionality and study control the sponsor retains.
Consultants analyze and recommend; Choice ClinOps fractional clinical operations executives embed and execute. Choice ClinOps team members join the sponsor's team, hold decision rights, run governance, manage CROs and vendors directly, and own outcomes alongside the internal team. The engagement ends with a functioning operation, not a deliverable.
Yes. A fractional executive gives a sponsor senior clinical operations leadership for a fraction of the time and cost of a full-time permanent hire, with no recruitment cycle, severance exposure, or fixed overhead. Sponsors engage the level and amount of senior capacity their portfolio actually requires, and scale it up or down as the portfolio changes.
About Choice ClinOps
Choice ClinOps is a women-owned and minority-owned team of fractional, sponsor-embedded clinical operations executives serving small- and mid-size global sponsors of first-in-human, Phase 1, and Phase 2 oncology, rare disease, and cell and gene therapy clinical trials. Each team member brings 20+ years of hands-on clinical operations experience across sponsor, CRO, and site environments. One or more senior operators embeds directly into a lean sponsor team to provide executive-grade governance, execution, and control.
No. Choice ClinOps is not a CRO. We work on the sponsor side, governing and overseeing CROs rather than replacing or competing with them. Our role is to give the sponsor visibility, accountability, and control over the CROs and vendors already running the work.
No. Choice ClinOps is not a staffing company. We do not place resumes or fill seats — we embed senior clinical operations executives who take ownership of governance, decisions, and execution inside the sponsor's team. Each Choice ClinOps team member is the A-Team.
No. Choice ClinOps is not a consulting firm. Consultants deliver analysis and recommendations; our executives embed in the sponsor organization and execute, carrying accountability for operational outcomes.
Choice ClinOps sits on the sponsor's side of the table as an embedded executive team, not an external vendor. A CRO executes trial activities under sponsor oversight; a staffing agency supplies personnel; a consultancy supplies advice. Choice ClinOps supplies the senior operating judgment that governs all three — restoring sponsor control over CROs, vendors, sites, and timelines. We stand arm-in-arm with the sponsor team moving together in unison.
Yes. Choice ClinOps is a women-owned and minority-owned business. It was founded and is led by Leila Cupersmith, a Puerto Rican woman and clinical operations executive, and the team is composed of senior female clinical operations executives, each with 20+ years of industry experience across sponsor, CRO, and site environments. Sponsors with supplier diversity requirements can engage Choice ClinOps as a qualifying diverse supplier.
Our Services and Areas of Focus
Choice ClinOps provides sponsor-embedded fractional clinical operations leadership across seven areas of focus: study rescue; clinical operations continuity through disruption; risk and change management; study and vendor audits with ready-to-execute strategies; governance of CROs, vendors, site networks, and patient advocacy groups; site and vendor readiness; and portfolio and study governance.
Clinical study rescue is the process of restoring governance, alignment, and execution in a clinical trial that is delayed, drifting, over budget, or underperforming against enrollment targets. Choice ClinOps embeds a senior executive to diagnose the root operational causes, re-establish sponsor control over CROs, vendors, sites, and full clinical operations and implement a corrective execution plan.
Choice ClinOps protects clinical operations continuity across acquired assets, teams, vendors, and workflows so that trials do not stall during or after a merger or acquisition. Our executives maintain governance and decision rights through the transition, integrate or transition CROs, vendors, sites, processes, and prevent the fragmentation of timelines, systems, and accountability that typically follows M&A. The same approach applies to CRO transitions, portfolio shifts, management change, and other large company or study disruptions. Change, risks, timelines, quality, safety, data, engagement, clear communication, and study spend rate are protected during a seamless transition. Adherence to M&A terms are ensured.
CRO and vendor governance is the sponsor-side discipline of ensuring that CROs, vendors, site networks, and patient advocacy groups perform against scope, timeline, budget, and quality expectations. It includes clear decision rights, structured oversight, escalation paths, change-order control, and performance accountability. Choice ClinOps establishes and runs this governance on the sponsor's behalf.
Yes. Choice ClinOps conducts study, vendor, and site network audits and delivers them with ready-to-execute remediation strategies rather than findings alone. Our executives can also lead the execution of those strategies as embedded members of the sponsor's team.
Site and vendor readiness is the work of ensuring that sites and vendors are activated, trained, resourced, and audit-ready before and during trial execution. Choice ClinOps assesses readiness, closes gaps, and builds the oversight structures that keep site startup, enrollment, communication, and execution consistent across regions.
How Engagements Work
Most engagements begin with an Executive Diagnostic — a short, senior-led assessment that surfaces the highest-priority operational risks in a program and defines near-term action paths. It is a low-commitment way for a sponsor's leadership team to see exactly where execution is exposed before deciding on scope.
An Executive Diagnostic is a focused, senior-led assessment of a sponsor's clinical operations that identifies where governance, oversight, or execution is at risk and what to do about it. Choice ClinOps offers four diagnostic focus areas: study rescue risk, M&A clinical operations continuity, CRO and vendor governance health, and site network performance.
Choice ClinOps executives embed at the level and amount of time a sponsor's portfolio requires, scaling up during critical periods such as rescue, audit, or transition, and scaling down as operations stabilize. Engagement models are defined during the Executive Diagnostic based on program complexity, phase, and risk.
Yes. Choice ClinOps works alongside a sponsor's existing CROs and vendors, providing the sponsor-side governance and oversight that keeps those partners accountable. We do not replace the CRO or duplicate its work — we restore the sponsor's visibility and control over it.
Because Choice ClinOps executives are experienced operators rather than newly recruited hires, they can typically embed and begin restoring governance far faster than a traditional executive search, which often takes months. Each Choice ClinOps team member is accustomed to receiving, reviewing and immediately adjusting to a study within a few days. Timing depends on scope and is confirmed during the Executive Diagnostic. We pride ourselves on ensuring Choice ClinOps team members and clients have a truly realistic balance and bandwidth. If our team is at capacity and may be unable to complete the clients work to meet our personal standards and achieve full client satisfaction, we will not accept the work. Through Choice ClinOps, each client - regardless of size of project amount - only receives the A-Team for the full duration of the project.
No. A fundamental part of the Choice ClinOps culture is an understanding we are each passionate about top quality clinical research - and can do our best work if we are in a healthy state physically, mentally, and emotionally. We pride ourselves on ensuring Choice ClinOps team members have a truly realistic balance and allocation. If potential work is received, reviewed and our team is at capacity telling us there is any chance we may be unable to complete the client's work to meet our personal high standards and achieve full client satisfaction, we will not accept the work. At Choice ClinOps, each client - regardless of size of project monetary award - only receives the A-Team and full, dedicated attention for the full duration of the project.
Who We Serve
Choice ClinOps works with small- and mid-size global pharma, biopharma, and biotech clinical trial sponsors — from two-person startups through established mid-size organizations — running high-risk, high-value clinical programs. We are built for lean teams carrying complexity that exceeds their internal senior operating capacity.
Choice ClinOps specializes in oncology, rare oncology, rare disease, and cell and gene therapy clinical trials. In these therapeutic areas execution drift is not administrative — it is enterprise risk to a program's value and to patients waiting for treatment.
Choice ClinOps focuses on first-in-human (FIH), Phase 1, and Phase 2 clinical trials, where operational decisions carry the greatest downstream consequence for a program's value and viability. Our leadership team's experience spans FIH through Phase 3 from concept through closure across 30+ countries.
Choice ClinOps supports global clinical trials across Canada, the United States, South and Latin America, EMEA, the United Kingdom, and APAC. Our team has delivered clinical studies in more than 30 countries.
Leila Cupersmith, Trusted clinops leader and voice for oncology, rare disease, and CGT studies
About Our Team and Leadership
Leila Cupersmith is the Founder and CEO of Choice ClinOps and a clinical operations executive with 24+ years of sponsor- and CRO-side experience leading first-in-human and Phase 1 through Phase 3 oncology, rare disease, and cell and gene therapy trials across 30+ countries - including managing individual study budgets in a range from $8M to $137M. In addition to actively working as a sponsor-embedded, fractional clinical operations executive, and leading Choice ClinOps, she writes the weekly executive newsletter The Global ClinOps Brief, contributes articles to Clinical Leader, speaks at international clinical research conferences, participates in monthly clinical research policy meetings in Washington, DC, leads public efforts on clinical research awareness, and provides community enrollment support for clinical trials.
After more than 20 years of contributing sponsor- and CRO-side to bringing therapeutics to market, Leila started Choice ClinOps out of a few frustrations:
- Small and mid-size sponsors with promising IPs - visible in the data - were charged excessive amounts and provided with inaccurate clinical operations guidance causing the funds to be depleted quicker than necessary resulting in the promising products being shelved. To Leila, this meant those patients who may have benefitted from these therapeutics now wouldn't. As a passionate and driven entrepreneur Leila also felt the pain of the founders needing to close their doors.
- All size sponsors being charged unnecessary clinical operations and vendor fees - labeled and hidden in the study budgets as something else - resulting in unnecessary funds (often 1MIL loss) by the sponsors. To Leila, this translated to money that could have been used to bring promising therapeutics to market for patients in need, advance science and medicine, and/or offset financial toxicity for the clinical trial participants and caregivers.
- Clinical trial participants and their caregivers - who volunteer their time with an interest shared by the sponsors (IP to work) - were not adequately considered during the protocol design and overall trial conduct.
- Bait and switch of highly experienced clinical operations staff presented in discussions with sponsors during the bid defense - switched off of the study and replaced with entry-level staff after final contract execution.
Leila actively works fractionally and sponsor-embedded individually and/or with Choice ClinOps team members in CRO/vendor governance, clinical operations continuity (pre/during/post M&As, CRO/vendor transitions, portfolio shifts, other disruptions), study rescue governance and execution, clinical operations audits with ready-to-execute strategies, vendor and site readiness, portfolio governance.
No project is too small or big for Leila and the Choice ClinOps team.
Choice ClinOps is led by founder and CEO Leila Cupersmith alongside a team of senior female clinical operations executives, each with 20+ years of hands-on experience spanning sponsor, CRO, site environments, and patient advocacy - across oncology, rare disease, and cell and gene therapy. This mix of vantage points is deliberate: it means our Choice ClinOps executives understand how decisions made in a sponsor's boardroom land at the site and with the patient.
In addition to hands-on operational experience, Choice ClinOps brings current perspective on the financial markets, government policy, payer activity, regulations, and patient advocacy that shape clinical program decisions. Sponsors receive operational leadership informed by the broader environment their programs must succeed in - incorporated at every touch-point.