Associate Clinical Project Manager

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Job Description

Job Responsibilities:(Primary Duties, Roles, and/or Authorities)

Under direct manager supervision, the Associate Clinical Project Manager will:

• Manage thequality and compliance of assigned clinical project(s) ensuring that they meet the highest standards for scientific quality, integrity and ethics and are conductedin accordance withBD global clinical procedures, study protocols, GCP and all applicable regulations.

• Plan and strategize with other business unit cross functional team members (R&D, Marketing, Quality, and other business partners) to define, implement and execute clinical strategies in support of businessobjectives.

• Demonstrate a comprehensive understanding of the therapeutic areas and competitive landscapes for assigned clinical project(s).

• Oversee the planning and execution of assigned clinical projects to ensure that deliverables are completed on time and within budget. Develop and manage metric reporting tools as needed to track project timelines and deliverables. Provide regular and ad hoc reporting of metrics to Clinical Affairs leadership.

• Manage activities related to clinical strategy and study design, global applications, submissions, and product launches for assigned clinical project(s) as the clinical subject matter expert.

• Develop Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Investigator's Brochure's (IBs), Clinical Study Management Plans, Study Process Risk Assessments, Regulatory Management Plans, Case Report Forms (CRFs), Clinical Product Management Plans, Clinical Investigation Reports (CIRs)and other essential clinical study documents.

• Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, clinical productmanagementand clinical supplier management.

• Develop and manage clinical study budgets and monthly financial reviews, including invoice review/approval and accruals for assigned clinical project(s).

• Manage complianceforrequired reporting, including but not limited to IDE annual reports, clinicaltrials.gov, and overseas notified bodies/competent authorities.

• Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that study files are current,accurate,completeand audit-ready.

• Oversee study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current,accurateand complete.

• Interact with and/or oversee interactions withinvestigationalsites, vendors, key opinion leaders (KOLs)and consultants.

• Manage external contractors/suppliers for assigned clinical project(s) to ensure that deliverables are completedon-time, within budget, and are consistent with the scope of work.

• Coach and ensure successful and effective relationships between study teams and investigational site personnel.

• Provide critical thinking and leadership support for issue escalation related to clinical study activities. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactivelyidentifyissues and create mitigation strategies in collaboration with Clinical Affairs leadership.

• Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to assigned clinical projects.

• Conduct Site Management & Monitoring, Clinical Product Management and Clinical Field support activities/visits, as needed.

• Conduct, attend, or support training and observational activities, as needed, for study teammembers.

• Bachelor's Degree (BS/BA) in life sciences (MA/MS preferred)

• 3+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)

• Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies

• Proficiencywith Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)

• Strong knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)

• Strong interpersonal and communication (oral and written) skills

• Strong organizational skills, attention to detail, criticalthinkingand analytical skills

• Able to manage and delegate multiple tasks and prioritize importance of tasks/projects

• Ability to understand and interpret technical, scientific, and clinical information as it applies to product approval activities

• Ability to lead teams to translate issues into actions, make decisions and influence outcomes

• Ability to travel up to 40% (or more during peak times)

• Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidneydiseaseand/or oncology

• Prior experience managing clinical projects (strongly preferred)

• Experience with medical device studies (strongly preferred)

• Prior experience with site management & monitoring

• Prior experience with Veeva Vault Clinical Suite (CTMS, CDMS and eTMF)

• Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)