Clinical & Regulatory Affairs Specialist Lazio

Clinical & Regulatory Affairs Specialist
Roma
Lazio, Lazio

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs, and market access.

Our offices are located in Germany, Italy, Switzerland, UK, and the United States, and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators.

Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden.

Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value.

We have the ability to transcend the current landscape with "smart" technology enabled data collection tools and insights.

Meditrial offers the highest level of expertise across multiple therapeutic areas.

We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards.

Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

Clinical & Regulatory Affairs Specialist: Industry: Lifescience Industry: Pharma, Medtech, Digital Health

Employment Type: Full-time

Job Functions: Clinical Affairs

Location: Meditrial, Via Po 9, Rome, Italy

Workplace: Office-based / availability to travel

Note: Applications not matching basic requirements will not be considered.

Responsibilities: Proactively manage project-level operations, including but not limited to, aspects including management of trial timeline, budget, resources with consideration of quality standards and risk mitigation. Provide efficient and effective updates on trial progress to the Medical Director as requested. Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection, and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets. Ensure effective project plans are in place and operational for each trial.

Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines, and regulatory requirements. Attend study update meetings, ensure meeting minutes are completed, distributed to team members, and filed in the TMF in a timely manner.

Review and approve site visit reports, ensure tracking, follow-up, and resolution of site-specific issues have been completed in a timely manner. Monitor the quality of deliverables, address quality issues with the appropriate team member, and identify opportunities to improve training, execution, and quality control across the clinical team. Qualifications: Education: Bachelor's degree in Life Sciences; Master in health-related field is a plus.

Languages: Proficiency in oral and written Italian and English (additional language considered a plus).

Previous experience in a pharmaceutical, CRO, or medical device company required.

Sound knowledge of GCP/CFR/ICH guidelines, ISO9001, and ISO14155.

Personal skills: Ability to communicate, problem solve, and work effectively in an international team. Innovative and self-motivated. Excellent organization skills and ability to prioritize goals and responsibilities. Ability to negotiate and communicate with clients professionally. Proficient computer skills with the ability to understand and assess technology alternatives and implications for current processes. Ability to be productive and successful in a dynamic work environment.

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