As a Project Assistant in Clinical Affairs, you will play a pivotal role in the day‑to‑day coordination and administration of our global clinical studies.
Working closely with Clinical Affairs Director, investigators, CROs and cross‑functional partners (Medical Affairs, Regulatory, Quality and Marketing), you will ensure that all study activities are executed on time, within budget and in compliance with ICH‑GCP, ISO 14155 and internal SOPs.
This position is ideal for an early‑career clinical research professional seeking to deepen their operational expertise and grow toward project‑management responsibilities in a dynamic, growth‑oriented organization.
Key Responsibilities include:
- Assist in the planning, initiation and execution of interventional, observational and post‑marketing studies.
- Coordinate submission documents and track regulatory and ethics committee approvals.
- Support the preparation and review of study protocols, informed consent forms and case report forms (CRFs).
- Maintain clinical project timelines, trackers and study documentation (eTMF/CTMS).
- Schedule internal and external meetings, document minutes and follow up on action items.
- Arrange logistics for investigator meetings, monitoring visits and audits.
- Liaise with investigators, study site personnel, CROs and vendors to drive compliance and engagement.
- Assist with data cleaning, query tracking and interim report preparation.
- Coordinate data transfers and validation between study sites and vendors.
- Monitor study budgets, reconcile invoices and oversee vendor contracts.
- Prepare presentations, dashboards and status reports for senior management.
Information about the job:
- This is a mainly remote role, we are looking for someone that can be based in Sweden, Italy, Portugal, Spain, and we are open to evaluate in case other countries.
- This position reports to our Clinical Affairs Director based in Italy.
Required qualifications and skills:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing or a related discipline.
- 1–3 years of experience in clinical research (sponsor, CRO or academic site), ideally within medical devices or pharmaceuticals.
- Working knowledge of ICH‑GCP and ISO 14155.
- Proficiency in MS Office and project‑management tools.
- Strong organizational skills and attention to detail.
- Excellent written and verbal English; additional fluency in a LATAM (ideally Portuguese) or APAC regional language (Chinese, Korean, Japanese...) is highly desirable.
- Ability to manage multiple priorities and timelines.
Nice to have (skills that can be developed):
- Experience with eTMF, EDC and CTMS systems.
- Familiarity with EU MDR and post‑market surveillance requirements.
- Basic data‑management or statistics knowledge.
Personality:
- Proactive self‑starter.
- Clear and confident communicator.
- Rigorous in documentation and follow‑through.
- Problem‑solver with a sense of urgency.
- Team‑oriented and service‑minded.
- Adaptable to change and ambiguity.
- Curious mindset for continuous improvement.
As part of Nordberg Medical's entrepreneurial spirit and teamwork philosophy, you should exhibit behaviors aligned with our values and employee mindset: Entrepreneur, Multiculturalism, Flexibility, Trust, Excellence and Authenticity.
