Sr Clinical Project Manager

Becton Dickinson Medical Devices•Sparks, NV

About The Position

The Sr Clinical Project Manager leads the planning and execution of complex in vitro diagnostic (IVD) clinical studies, ensuring study results are completed on time and within budget. The role develops clinical study documents and safety plans, manages study budgets and vendors, oversees study-team deliverables, and ensures studies comply with company policies and applicable regulatory requirements. The position also supports cross-functional teams as a clinical study subject matter expert, develops standardized clinical research processes, maintains trial master file documentation and clinical study registrations, and reports study progress to stakeholders. The position is based at the listed primary work location in Sparks, Maryland. BD states that most roles require at least four days of in-office presence per week; remote or field-based arrangements are identified separately in a posting. No specific arrangement is identified for this role. The minimum qualification is a degree-level qualification or an equivalent combination of education and experience.

Requirements

Degree-level qualification, or an equivalent combination of education and experience.
Strong oral and written communication skills.
Excellent time management, project management, and organizational skills, including the ability to manage multiple tasks simultaneously.
Ability to work independently, show self-direction and initiative, and work with minimal supervision.
Ability to work effectively with other professionals as part of a diverse team.

Responsibilities

Lead planning and execution of complex IVD clinical studies, including developing study timelines and delivering results on time and within budget.
Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential study documents.
Develop clinical safety plans and monitor, evaluate, and manage participant safety throughout trials.
Develop clinical study reports for submission to regulatory authorities.
Develop and track study budgets, including reviewing and approving invoices and preparing monthly accruals.
Oversee and review study-team deliverables for quality and compliance.
Manage external vendors to ensure deliverables meet schedule, budget, and scope requirements.
Ensure studies comply with company policies, standards, procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations.
Identify potential problems, take preventive action, recommend solutions, and track lessons learned.
Serve as a clinical study subject matter expert on cross-functional project teams and demonstrate understanding of relevant business functions, products, and procedures.
Develop and implement standardized clinical research processes and operating procedures.
Create and maintain clinical study documents in the trial master file (TMF).
Interact with investigational sites, vendors, key opinion leaders (KOLs), and consultants.
Conduct on-site clinical monitoring activities as needed.
Lead and participate in cross-functional team meetings.
Prioritize tasks and responsibilities and ensure project milestones are met or exceeded.
Prepare and present clinical trial progress reports to key stakeholders.
Create and maintain timely clinical study registration updates, including ClinicalTrials.gov or global registrations for studies conducted outside the United States.