Lead CRA (IHCRA)

Job content

We are looking Germany wide for a Lead CRAKey Responsibilities:

• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices),and relevant regulatory requirements (e.g. ISO 14155).
• Develop and deliver technical training on GCPs, and relevant regulatory requirements (e.g. ISO 14155),, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
• Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study site management including Institutional Review Boards, Contract, and Training, and developing process improvements.
• Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
• Act as a mentor to new or junior level employees
• Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects
• Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
• And also low travel responsibility

Education and Experience:Bachelor’s Degree or Equivalent in in related field , 5 years years experience of previous experience monitoring a clinical trial RequiredAdditional Skills:

• Excellent written and verbal communication skills and interpersonal relationship skills
• Strong problem-solving and critical thinking skills
• Good ability to read and write English preferred
• Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Full understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
• Excellent written and verbal communications skills
• Advanced problem-solving skills
• 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 company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

What is it like to work at Edwards Lifesciences in Germany?As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).Edwards Lifesciences in Germany also offers the following benefits:

• Competitive Compensation and Benefits package
• Flexible working hours, remote working
• Pension plan Risk
• Insurance Meal Benefits
• Service Awards Enhanced
• Leave Benefits
• Transportation Benefits
• Employee Stock Purchase Programme
• Employee Assistance Programme
• Comprehensive Wellness Programme including onsite gym, yoga classes and massage, preventive health checks, healthy lifestyle webinars, educational events, charity activities and much more.

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.