Senior Clinical Trial Operations Specialist

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

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.