Senior Clinical Trial Assistant

HiTalento TALENTO ApS; Cambridge (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Hemab in Cambridge, MA is seeking a Senior Clinical Trial Assistant to join the Clinical Operations team. You’ll own study activities, maintain TMF and ensure inspection-ready documentation as the HMB-002 program advances.

This hands-on role offers growth toward clinical trial management, working with CROs, sites, and internal colleagues to keep trials on track and deliverables moving.

Qualifications

• Experience in interventional clinical trials within biotech, pharma, CRO or regulated settings.
• Hands-on TMF documentation experience and inspection readiness.
• Working knowledge of ICH-GCP and clinical trial conduct requirements.
• Ability to coordinate activities across study teams, sites and vendors.
• Judgement to spot missing information or risks and take ownership to address them.

Responsibilities

• Own core HMB-002 study activities and deliverables with clear ownership of actions and timelines.
• Maintain inspection-ready trial documentation and TMF, closing gaps promptly.
• Drive study start-up, site activation, maintenance and close-out activities.
• Track enrolment, risks and actions to keep the team informed.
• Collaborate with CROs, vendors and sites to resolve daily issues.
• Partner with Clinical Ops, Clinical Dev, Medical and Regulatory to keep data accurate.
• Develop study trackers and templates to provide clear progress views.
• Increase responsibilities toward clinical trial management as expertise grows.
• Coordinate study meetings, agendas and minutes as needed.

Skills

Interventional trials

TMF experience

ICH-GCP knowledge

Cross-functional coordination

Ownership & accountability

Job description

Reporting to: Director, Clinical Operations

About Hemab

Hemab is building preventative treatments for serious, underserved bleeding disorders. These are therapies designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. We're patient-first, science-led and clinical-stage - with a pipeline that takes different scientific approaches to different patient needs.

We went public via our 2026 IPO, and we're scaling across two homes: Cambridge, MA, USA, and Copenhagen, Denmark.

The role

HMB-002 is at the centre of our work in von Willebrand disease, and delivering its clinical studies well is one of the most important things we need to get right. As Senior Clinical Trial Assistant, you'll be part of the Clinical Operations team responsible for making that happen.

This is a hands‑on role with more ownership than a traditional CTA position. You'll work closely with the HMB-002 study team, sites and external partners, keeping study activities moving, documentation inspection‑ready and issues from sitting unresolved. For someone ready to move towards clinical trial management, there's room here to take on more as the study progresses.

What you’ll do

• Own core HMB-002 study activities and deliverables, keeping actions, documentation and timelines moving across the study.
• Maintain accurate, complete and inspection‑ready trial documentation, including the TMF, and resolve gaps before they become larger issues.
• Drive assigned study start‑up, site activation, maintenance and close‑out activities, with clear ownership of actions and deadlines.
• Track site and study progress, including enrolment activity, risks and outstanding actions, so the team knows where attention is needed.
• Work directly with CROs, vendors and study sites to resolve day‑to‑day issues and keep HMB-002 activities on track.
• Partner with Clinical Operations, Clinical Development, Medical, Regulatory and other colleagues to keep study information accurate and decisions moving.
• Build and maintain practical study trackers, templates and ways of working that give the HMB-002 team a clear view of progress without adding unnecessary complexity.
• Take on increasing responsibility for study delivery as your experience grows, developing towards clinical trial management.
• Coordinate study related team meetings, plan and distribute agenda/minutes as needed.

What you’ll bring to Hemab

• Experience working on interventional clinical trials within biotech, pharma, a CRO or another comparable regulated environment.
• Hands‑on experience with clinical trial documentation and the TMF, with a clear understanding of what inspection‑ready documentation requires.
• Working knowledge of ICH‑GCP and the requirements governing clinical trial conduct.
• Experience coordinating activities across study teams, sites, CROs or external vendors and following actions through to resolution.
• The judgement to spot missing information, slipping actions or study risks and take ownership of getting them addressed.

Nice to have

• Experience in rare disease, haematology, coagulation or von Willebrand disease.
• Experience with study start‑up, site activation or patient enrolment activities.
• Experience in a smaller or growing biotech where the study team is building some of its own ways of working.

What to expect, honestly

Hemab is still building a lot of its own structure. Systems here tend to get created as we need them, not handed down in advance. Whoever takes this role will likely build some of their own process instead of inheriting a finished one. We work across two hubs and multiple time zones - bridging that well takes real, deliberate effort. And because we're growing quickly, priorities can shift with less notice than they would at a larger, more established company.

For a company our size, how you work weighs as heavily as pedigree. We value people who take charge without ego, work well across functions and want to create useful structure rather than wait for someone else to provide it. Good structure here should help people move faster and trust the work.

Why Hemab

HMB-002 is being developed for people living with von Willebrand disease. Your work will sit close to the point where our science becomes a potential preventative treatment for those patients. You'll also join at a stage where you can grow beyond the traditional boundaries of a CTA role and build broader clinical trial management experience.

How we treat our people is meant to be an extension of how we think about patients: with care, honesty, and respect. We're still building the consistency to back that up across every hiring process, every time. We'd say that plainly instead of pretending otherwise. If any part of your experience with us falls short of it, tell us.

Hemab builds balanced candidate slates and assesses everyone against a single standard. If you need a reasonable adjustment at any stage of the hiring process, please tell us.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.