Clinical Compliance Manager | Tlp-734 |

hace 3 semanas


Sevilla, España Mölnlycke A tiempo completo

Clinical Compliance Manager | [TLP-734] Seville, AndalusiaIf you're ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You'll be helping to equip medical professionals around the world with solutions to improve outcomes for patients. And you'll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose. Are you a seasoned clinical research professional with a passion for compliance and a knack for navigating complex regulations? Do you have a proven track record of ensuring adherence to research guidelines and driving quality in clinical evidence generation? If yes, we want to hear from youMölnlycke is seeking a Clinical Compliance Manager to join our Clinical, Medical, and Professional Affairs organisation. This is an opportunity to work independently, at HQ or remote, and at the same time be a part of a team in a fast-paced, dynamic environment globally.About the jobAs the Clinical Compliance Manager at CMPA, you will play a pivotal role in ensuring adherence to regulatory requirements, standards, and company policies across all clinical generation activities. You will lead efforts to uphold best practices in clinical research and ensure full compliance with regulatory frameworks. This position involves spearheading the development, implementation, and upkeep of robust clinical quality management systems and standard operating procedures. You will report to Senior Manager Clinical Compliance.Key responsibilities include:Ensure that all clinical research activities comply with applicable regulations and standards.Maintain, implement and update Clinical, Medical, and Professional Affairs (CMPA) Standard Operating Procedures (SOPs) to meet regulatory requirements.Stay current on regulations and industry standards to ensure compliance and provide in-house expertise on clinical evidence generation, clinical data collection, and relevant healthcare compliance.Define training needs and keep the department informed and trained on relevant rules, regulations, and guidelines.Manage CMPA's audit-related activities, including vendor qualification and clinical studies.Responsible for managing and monitoring NC, CAPA, planned deviations, and other clinical quality-related activities at CMPA.Liaise with internal and external parties involved in legal, quality, and regulatory affairs to anticipate and respond to new developments in clinical evidence generation.Mentor and support other team members.What you will need:Academic background in Life Sciences (medical, clinical, regulatory, or scientific).Minimum 6 years of experience in Clinical Research within Medical Device/Pharmaceutical/CRO industries.In-depth knowledge of clinical research rules, regulations, guidelines, and industry trends.#J-18808-Ljbffr



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