Edwards Lifesciences Associate Manager, Clinical Operations (THV) in Unterschleissheim, Germany
Negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts.
• In consultation with Edwards’ Legal department, Initiate, draft, redline, and negotiate 3rd party complex contracts, including clinical trial agreements, based on full knowledge of legal, financial, regulatory and clinical requirements
• Lead, direct, and evaluate the daily operations of staff in the area of clinical trials; plan, prioritize and delegate tasks to ensure operational efficiencies and compliance with policies as well as relevant regulations and laws
• Collaborate with key stakeholders to provide guidance on contracts terms and conditions. Identify risks and key stakeholders to the company
• Develop study budgets (e.g. study and/or vendor) based upon fair market value assessments & negotiate budgets with clinical sites and vendors/consultants
• Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions
• Other incidental duties
Education and Experience:
Bachelor's Degree (or local equivalent degree) in related field, 8 years of previous related experience in contract and budget negotiation/administration required
Experience in healthcare-related contracts strongly preferred.
Advanced degree in related field or Contract or legal degree.
Experience in international contract administration preferred.
• Ability to supervise/lead employees
• Ability to analyze and adjust operations to improve efficiency
• Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Demonstrated problem-solving and critical thinking skills
• Full knowledge of medical terminology and healthcare compliance and privacy regulations
• Advanced proficiency in Microsoft Office Suite, including Excel, and Word
• Excellent written and verbal communications skills
• Advanced problem-solving skills
• General knowledge of clinical research and operations acumen
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.