Clinical Affairs Project Manager

Clinical Affairs Project Manager #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Responsibilities: Participate on cross functional core project team to ensure clinical deliverables are aligned with Business Unit and/Corporate objectives; Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget; Support regulatory submission activities globally where clinical study data is needed to show product safety and efficacy; Developerp and manage study related documents and materials such as study protocol, investigational plans, case report forms, study manuals, monitoring plan, informed consents, investigatbrochure, websites, recruitment materials and other study related tools; Developerp and manage overall study budgets; negotiation of budgets with clinical sites, vendors, and consultants Coordinate the Developerpment, drafting, and submission of clinical reports, clinical study data, and Summary of Safety and Effectiveness Data. Support and provide data reviews of abstracts, manuscripts, presentations, Instructions fUse, and other materials that include study data; Support product launch activities as needed; Select and manage external vendors(including but not limited to CROs, core labs, and physician consultants) to ensure that deliverables are completed on time, within budget, and are consistent with the scope of work; Developerp an understanding of competitive landscapes fassigned products and therapeutic areas; Demonstrate understanding of Business Unit general business functions, products, and procedures; Conduct on-site clinical monitoring/quality activities as needed; Interact with investigative sites, vendors, and other functional areas to ensure successful execution of a clinical trial; Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and good clinical practice; Oversee and review work product of project team members to ensure quality and compliance, providing training mentoring as needed; Oversee appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements; Plan investigatand coordinatmeetings and prepare and present meeting materials; Oversee Developerpment and management of clinical database; Developerp and implement standardized processes and operating procedures fconducting clinical research; Provide direct line management fClinical Affairs personnel as needed. Required Qualifications: BA/BS (MA/MS preferred) in health science field equivalent combination of training and experience 4+ years of experience in the Clinical Research Industry; 2+ years of experience in managing clinical research studies; Previous site monitoring experience is preferred; Previous experience managing personnel is preferred; 3 + years experience with peripheral vascular devices is preferred; 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 computer skills; Proficiency with MS Windows based applications; Strong interpersonal and organizational skills; Ability to work independently, manage multiple projects and personnel in a fast paced environment, and effectively navigate obstacles; Travel of 20-40 domestic and international required Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, ship status, marital domestic civil union status, familial status, affectional sexual orientation, gender identity expression, genetics, disability, military eligibility veteran status, any other protected status.