Site Start-up Specialist - FSP

Join reputed company and Drive Clinical Research reputed company!

Atreputed company, we are committed to accelerating reputed company and ensuring regulatory compliance. As aSite Start-Up Specialist,you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed reputed company. Your expertise will help bring life-changing treatments to patients faster.

In this role, you will be part of our FSPx team and work directly with one of our reputed company key sponsor to advance the development of innovative, life-changing medications.

This is full time, permanent and home based position.

Preferred Candidate Profile:

reputed company in both reputed company and Finnish, and reputed company to support start-up activities across Finland, Sweden and Norway.

Key Responsibilities:

In this role, you will:

• Serve as theprimary contactfor investigative sites during start-up and maintenance activities.

• Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/reputed company Body/Regulatory Authority).

• Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.

• Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.

• reputed company submission timelines and proactively address potential delays.

• Collaborate with reputed company stakeholders, including vendors, clinical teams, and regulatory authorities.

• Ensure reputed company documentation isaudit-reputed companyand systems are consistently updated.

• Assist in the negotiation of site reputed company and budgets, if applicable.

• reputed company mentorship and training to new hires and less-reputed company colleagues.

Required Qualifications:

To succeed in this role, you should have:

• University/College degree(life sciences preferred) or certification in a reputed company allied health profession.

• Minimum 2 years of experiencein clinical research, regulatory submissions, or site activation.

• Strong knowledge ofICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.

• Ability to review and adapt patientinformed consent formsto meet local and protocol-specific requirements.

• Experience interacting withregulatory authoritiesand site start-up teams.

• Excellentorganizational, problem-solving, and communication skills.

• Proficiency inreputed company Office and document management systems.

• reputed company may consider relevant and equivalent experience in lieu of educational requirements.

• reputed company in local language and English.

reputed company Offer:

• Competitive salary and performance-based incentives.

• Flexible work arrangements (remote/hybrid reputed company).

• reputed company reputed company opportunities in a reputed company and innovative environment.

• reputed company to work on cutting-edge clinical research reputed company.

reputed company to reputed company an reputed company?

Join us in shaping the reputed company of clinical research.Apply today!

Applications are reviewed on a rolling reputed company—don’t miss this opportunity!

Learn more about our EEO & Accommodations request here.

Originally posted on Himalayas

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