Clinical Operations Lead

Corsmed | Stockholm, or remote within Sweden

The role

Magnetic resonance imaging (MRI) is one of the most powerful diagnostic tools in medicine, but also one of the most constrained, since scanners are expensive, scan times are long, and trained operators are scarce. Many people who would benefit from an MRI never receive one.

Corsmed is developing software with the aim of making MRI examinations substantially shorter, so that more people can be imaged, earlier, in more places, at a lower cost.

We are a team of approximately 25 people, headquartered in Sweden, working remotely across ten countries, and backed by US and EU VC investors.

Why this role exists

Data, more than science, sets our pace now. Every improvement we make and every regulatory submission we prepare depends on clinical image data acquired from the right participants, at the right sites, on the right scanners, and delivered in usable form.

This essential activity needs to run at a predictable and growing rate across several sites, scanner vendors and pathologies, and it paces nearly everything else we do, which is why we regard the Clinical Operations Lead as one of the most important open roles at Corsmed. The person in it owns the work from end to end, from the first conversation with a site to the dataset that reaches our scientists.

What you will own

You will own clinical image data acquisition end to end, from the selection of a site, through its activation and its day-to-day management, to the dataset that reaches our scientists, in a function that you build rather than inherit. You will:

• build the network of sites, by identifying, qualifying and engaging university hospitals, imaging centres, diagnostic clinics, contract research organizations and imaging core laboratories, first in Sweden and the Nordics and then more widely in Europe, negotiating the agreements, and establishing which sites see the patient populations relevant to our work, can acquire to specification and can proceed at a workable pace, and assessing early whether each site can meet our ethical, data protection and quality requirements;

• bring each site online, covering the site agreement, the participant information and consent process, data protection and data handling, testing of the data transfer path, and support for the regulatory and ethics submissions, through to the initiation visit at which the site is trained and released to start. You will work closely with our Head of Clinical, Regulatory and Quality Affairs, ensuring that every site is fully compliant before a single image is acquired;

• manage each site once it is live, which is the day-to-day work of coordination, recruitment tracking, data flow, and the completeness and quality of what is returned, resolving matters with the site when things do not go as planned, and closing each site out in good order once its contribution is complete;

• build the system that allows the work to scale, comprising the site activation playbook, the templates, the tooling, and the tracking and reporting that we reuse from country to country and from anatomy to anatomy;

• own the outcome, which is durable site collaborations that deliver complete, quality-checked datasets across the pathologies, scanner vendors and field strengths our development roadmap requires.

You will report to our Head of Clinical, Regulatory and Quality Affairs.

Who you are

You have coordinated or managed multi-site imaging studies, at a contract research organization, an imaging core laboratory, a clinical operations team in pharmaceuticals or medical devices, a hospital research unit or a comparable setting, and you bring roughly five to ten years of clinical research or clinical operations experience. You know how sites are identified and initiated, how a regulatory and ethics application is assembled, and what makes a collaboration with a site work.

You do not need a technical or MRI background, since we have physicists. You will need to become comfortable with the vocabulary of imaging studies, including field strength, vendor platforms, DICOM, protocol versions and protocol deviations, because you will be the link between our MR scientists, radiographers, clinical collaborators and data engineers.

We are looking for someone who is:

• effective with people, since much of the work consists of conveying the value of the research to busy clinicians and administrators for whom it is not their day job. Credibility and people skills matter more here than credentials;

• a capable project manager, across many sites, several countries and a large number of moving parts;

• comfortable with ambiguity, because parts of this playbook do not yet exist and you will write them;

• rigorous where it counts, putting the research participant first and treating compliance as a condition of the work rather than an administrative exercise, with a working knowledge of the ethical and regulatory framework in Europe;

• evidence-driven, so that when things do not go as planned you work with the site to establish where the constraint lies, whether in referral volume, eligibility, scanner availability or study workflow, and you resolve it.

The following would strengthen an application:

• a network among imaging sites in Sweden or the Nordics;

• Swedish language skills and familiarity with the Swedish research ethics and research office landscape;

• experience of ethics and regulatory submissions in one or more other European jurisdictions;

• experience of working within, and of owning processes in, a quality management system according to ISO 13485;

• a working knowledge of frameworks such as GCP, ISO 14155 and the Medical Device Regulation;

• experience of managing contract research organizations or other external suppliers to timelines and deliverables;

• additional European languages.

Why join

We offer:

• scope, because you will own a broad role, covering strategy, partnerships, negotiation, operations and systems design, and you build it rather than inherit it;

• influence, since we are approximately 25 people with few layers between the work and the decision, so you will work directly with our leadership;

• impact, both externally and internally, because faster and cheaper MRI changes who gets imaged and when, and because this role is load-bearing for the whole company as our clinical programme develops;

• ownership, in the form of a competitive salary together with equity participation, since we want you to own a piece of this.

Practical

The practical terms are the following:

• Location: Sweden strongly preferred, either Stockholm or remote within Sweden.

• Travel: as needed, visits to partner sites and similar.

• Employment: full-time, permanent.

• Start: as soon as possible.

• Applications: send your CV to erik@corsmed.com, or apply through our careers page.