Clinical & Regulatory Affairs Specialist

vor 6 Monaten

Berlin, Deutschland Meditrial Europe Ltd. Vollzeit

**Company Overview**:
Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market efficiently and compliantly. Our dedicated team of experts ensures the highest quality standards and compliance with regulatory requirements.

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

**Employment Type**: Full-time

**Job Functions**: Clinical/ Regulatory Affairs

**Location**: Meditrial,Kantstrasse 21, 10623, Berlin

**Workplace**: Office-based

**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**:
Master’s degree in life science, healthcare management, preferred degrees include Medical Engineering, PharmD, MD, and/or PhD
**Language skills**: fluent English and German, Italian or French are 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
Over 5 + years of experience in clinical trial management medical device or drug
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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