BD (Becton, Dickinson and Company) CRA Manager in United States
The CRA Manager is an integral member of the Clinical Affairs Operations (ClinOps) Management Team, reporting to the Manager, Clinical Operations.
The CRA manager is responsible for direct supervision and/or general oversight of site management and monitoring activities across our Global organization. The successful CRA Manager will regularly demonstrate exceptional analytical and problem solving skills to mitigate risk and deliver high quality results. They possess strong interpersonal, written and verbal communication within all levels of the organization and our external partners, and raise the performance level of individuals and project teams by driving competence and continuous improvement throughout our Global CA organization.
Under the direct supervision of the Clinical Operations Manager, CRA Manager will:
Perform supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, development, interviewing and hiring decisions, and disciplinary actions.
Perform supervisory responsibilities for outsourced/contract CRAs, including interviewing and hiring decisions, training, development, and disciplinary actions. Manage the quality and consistency of outsourced CRA services via supervision and co-monitoring (as necessary) across multiple projects.
Track and manage monthly pass-thru and hourly costs of outsourced CRAs. Ensure alignment with project budget(s).
Actively manage CRAs, providing project assignments and training to meet current or future division needs.
Development and management of CRA metrics reporting, including visit report completion, data verification completion, CRA capacity and efficiency. Provide proactive risk identification and mitigation strategies through weekly and/or ad hoc reporting to inform recommendations to Clinical Affairs Management or Project Managers. Evaluation of metric data to identify process improvement opportunities.
Research and implement cost effective monitoring strategies for business unit sponsored studies.
Lead, direct others, or participate in the development and implementation of standardized processes and procedures for clinical research operations including but not limited to monitoring and clinical systems.
Conduct on-site clinical monitoring/quality activities as needed, including investigational product accountability, subject screening/enrollment assessments, case report form
A minimum of 7 years experience monitoring and managing investigational sites with at least 4 years of managerial experience
Prior experience leading professional staff in a clinical research environment preferred
Strong computer skills
Proficient knowledge of FDA regulations regarding device research and development is required
Excellent communication skills (oral and written)
Strong attention to detail
Strong interpersonal and organizational skills
Ability to work independently, manage multiple tasks and personnel in a fast paced environment
Ability to travel up to 40%
BA/BS in Health Science Field or equivalent combination of training and experience
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.
Division Name: Bard Peripheral Vacsular
Relocation Available?: Yes
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.