Clinical & Regulatory Affairs Specialist

Clinical & Regulatory Affairs Specialist Meditrial Europe Ltd. Minneapolis, MN Job Details Full-time 7 hours ago Qualifications Pharmaceutical company experience Full Job Description 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:

Industry:

Lifescience Industry:

Pharma, Medtech, Digital Health Employment Type:

Full-time Job Functions:

Clinical Affairs Location:

Minneapolis Workplace:

Office-based / availability to travel

Note:

Applications not matching basic requirements will not be considered The ideal candidate has Regulatory and Clinical Operations experience in the pharmaceutical, medical devices and/or Biotechnologies industries. The role will be responsible for the management and direction of the Clinical Affairs department for the conduct of trials across Europe and US. He/She will ensure study conduct in compliance with applicable ISO standards, GCP and SOPs, providing expert advice in the best pathways to achieve study approval in Europe and US. He/She will work in close collaboration with the Project Lead and will be accountable for achieving successful deliverables from the clinical team to the Sponsors factoring regulatory requirements, timelines, scope of work and respecting budgets. 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 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