BD (Becton, Dickinson and Company) Clinical Trial Manager in New Hope, Minnesota
Trailblazing Innovation for Patients
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products. Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients. Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.
The individual in this position will participate on multi-disciplinary project teams to plan and execute successful clinical studies in support of corporate objectives. The Clinical Trial Manager will demonstrate proficiency in all areas of clinical study development and execution, with an ability to build and direct effective multi-disciplinary project teams.
Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget
Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
Interact with investigative sites through training and ongoing communication to ensure successful execution the clinical trial
Assist with oversight of clinical trial monitoring including attendance at qualification, initiation, monitoring, and close-out visits as needed
Oversee the appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
Plan investigator and coordinator meetings and prepare and present meeting materials
Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and Good Clinical Practices
Select and manage external vendors/CROs to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
Participate on cross-functional core project team to ensure clinical deliverables are aligned with corporate objectives
Develop an understanding of competitive landscapes for assigned products and therapeutic areas
Demonstrate understanding of Lutonix general business functions, products, and procedures
Coordinate the development and submission of clinical reports and abstracts/manuscripts
Oversee development and management of clinical database
Provide work direction to study team and may manage Clinical personnel
6+ years of experience in the Clinical Research Industry
Strong computer skills with a proficiency with MS Windows based applications
Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials
Excellent communication skills (oral and written)
Strong interpersonal and organizational skills and the ability to manage multiple tasks
Ability to work independently and provide work direction to others
Able to travel 20% on average and up to 40% during peak periods
2 + years experience with peripheral vascular devices
2+ years experience in managing clinical research studies
Previous experience with EDC systems
Device/drug combo technology experience
Experience managing direct reports preferred
Demonstrated ability to work effectively on cross-functional team
2+ years of experience managing personnel is preferred
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
While performing the duties of this job, the employee may be in an open cubicle environment. Employee must be able to work in a team-oriented, fast-paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Industry Standard/Category: Clinical Trail Manager
Career Level: experienced
Division Name: Lutonix, New Hope, MN
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.