Freelancer Site Start-up Associate (Scandinavia Region)

Location
Home based Sweden
Salary
Competitive
Posted
18 Dec 2018
Closes
23 Feb 2019
Ref
3147AE
Contract Type
Contract

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it! 

We’re looking for a talented and energetic Site Start-Up Associate (Freelance) to join our team to cover all Scandinavia Region. This is an opportunity for 3-6 months, pipeline dependent and up to 0.5 FTE.

Imagine. Inspire. Innovate. Impact. With Us.

You'll be accountable for: 

Prepare and perform all applicable regulatory and EC related submissions in the Scandinavia region.

Collection and QC of essential documents.

Liaising with internal team members for project updates.

Providing country-level intelligence on site start-up.

Preparing, reviewing and submitting study amendments/notifications

Safety reporting submissions/notifications.

Providing quality review of the informed consent and adapting the template as appropriate.

Negotiation and completion of Clinical Trial Agreements, CTA Amendments and study budgets.

Study feasibility (Investigator outreach, CDA and questionnaire completion)

other agreed study related tasks.

You'll need this to be considered:

An undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional

Experience within submissions and site start up in across the Scandinavia region

Prior experience using computerized information systems preferred

Ability to read, write, and speak fluent English; fluent in other Scandinavia Countries

Clinical trials support or pharmaceutical industry experience preferred

Office based or clinical employment experience preferred

Knowledge of ICH and local regulatory authority drug research and development regulations preferred

Ideally available to start immediately