Job Description

Job Description Summary

The successful Associate Clinical Project Manager (APM) will assist in the planning and execution of clinical studies, from concept through study completion, in support of corporate objectives. Additionally, the APM ensures that projects are completed on time, within budget, and in compliance with all regulatory requirements, Good Clinical Practice, & industry standards. The APM assists the department leadership in providing oversight of the day-to-day activities of project team members and participates in personnel development as needed.

Job Description

Under the direct supervision of the Clinical Program Manager, Sr. Clinical Project Manager and/or Clinical Project Manager, the APM will:

Assist in the planning and execution of clinical studies, including clinical study timeline development, ensuring that project deliverables are completed on time and within budget
Assist in the development of clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents
Assist in the development of clinical study reports and support regulatory submissions
Assist in the development and tracking of the clinical study budget, including invoice review/approval and monthly accruals
Oversee and review deliverables produced by study team members to ensure quality and compliance
Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
Ensure that studies comply with BD policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations
Demonstrate understanding of BD’s general business functions, products, and procedures and serve on cross-functional project teams as a clinical subject matter expert
Assist in the development and implementation of standardized processes and operating procedures for conducting clinical research
Create and maintain clinical study documents as part of the trial master file (TMF)
Interact with investigational sites, vendors, key opinion leaders (KOLs), and consultants
Conduct on-site clinical monitoring activities as needed
Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)                

Required Qualifications:

Three (3) or more years of experience in Clinical Research
Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies
Ability to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles
Excellent communication skills (oral and written)
Strong computer skills
Proficiency with Microsoft Office Suite applications
Strong interpersonal and organizational skills
Ability to travel up to 30%          

Preferred Qualifications:

One (1) or more years of experience managing clinical research studies
One (1) or more years of CRA or site monitoring experience
Experience with medical device studies
Therapeutic knowledge and/or experience with peripheral vascular devices for PAD, ESKD, and/or Oncology
Prior experience in managing, mentoring and developing staff

Education and/or Experience:

BA/BS (MA/MS preferred) in health science field or equivalent combination of training and experience    

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.