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AbiomedMehr sehen

addressAdresseDeutschland
KategorieBusiness

Jobbeschreibung

Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 2,000 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore.

Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Job Description:


The Manager Clinical Field Operations EMEA is responsible for the oversight, growth, and development of our inhouse and remote Lead Clinical Research Associates/ Clinical Research Associates and Clinical Trial Associates. The Manager Clinical Field Operations EMEA is expected to manage site and vendor (e.g. Clinical Research Organization) related matters in collaboration with Clinical Program Managers, and with supervision from the Assoc. Dir, Clinical Affairs and Programs, EMEA & APAC. This person will train, manage, and develop CRAs and CTCs to ensure clinical trials are conducted in a controlled, compliant way, such that safety and privacy of the subjects is ensured with the highest level of data quality and integrity.


Primary Duties and Responsibilities:


  • Responsible for hiring, training and retaining a diverse group of in-house and remote CRAs/CTCs, ensuring adherence to pertinent regulations through participation in site visits, regular review of EDC system metrics, Trial Master File review, monitoring reports, communications with Clinical Program Managers, study site personnel, and others as needed
  • Accountable for the development of direct reports through performance reviews, instruction, mentoring, and coaching. This includes setting goals, conducting periodic and year end performance reviews, bi-annual CRA assessment visits, proactively identifying and addressing any areas of concern, providing development opportunities to team members and as needed, escalating performance and/or personnel issues
  • Development and maintenance of CRA metrics utilizing Clinical Trial Management System (CTMS)
  • Collaborate with Clinical Program Managers to identify needs for additional training and to create/refine processes that impact CRA conduct, ensuring consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines
  • Work closely with Clinical Program Managers to ensure that all studies are appropriately resourced from a monitoring and study support standpoint. This includes tracking resource utilization
  • Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education
  • Responsible for developing and implementing training programs to train and mentor new clinical research staff as well as providing ongoing education and mentorship to experienced staff
  • Support CRAs/CTCs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents
  • Develop a familiarity with the protocols, study timelines, inclusion and exclusion criteria, and enrollment goals
  • Ensures inspection readiness activities and audit activities performing Trial Master File (TMF) site audits on a regular basis
  • Works with the Clinical Program Manager to ensure that all CAPAs are adequately developed, reviewed and implemented
  • Facilitates collaborative environment through team building activities and leadership


Job Qualifications:


  • BS degree in biological sciences or related medical/scientific field
  • 8+ years direct clinical research experience with at least 3 years directly managing CRAs required.
  • Previous experience as a (Lead) Clinical Research Associate required
  • Expertise with GCP and regulatory compliance guidelines for the conduct of clinical trials required
  • High attention to details and accuracy; Excellent prioritization and organizational skills; excellent cross functional team leadership and participation skills
  • Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
  • Experience managing the operation of clinical studies of Class Ill cardiovascular devices strongly preferred
  • Proficient with computer programs including Microsoft Office suite and Microsoft Project
  • Travel up to 40% of the time - Position is field based with regular monthly trips to Headquarters


We offer:


  • Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives"
  • Comprehensive induction program with structured onboarding plan throughout the orientation phase
  • Company pension allowance of up to 1,500 euros per year and capital-forming benefits
  • Benefit packages for occupational disability insurance and company group accident insurance
  • Full cost coverage for a job ticket in the Aachen or Berlin area
  • Various health programs and a leasing option for a job bike


ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.

Refer code: 638507. Abiomed - Der vorherige Tag - 2023-01-19 21:15

Abiomed

Deutschland

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