Clinical & Regulatory Affairs Specialist

4 giorni fa

Lazio, Italia Meditrial Europe Ltd. A tempo pieno

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, 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 highest level 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**:
**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 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 in a professional manner
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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