The Associate Director, ClinicalOperationsis responsible forsupporting BD’s businessobjectivesby overseeing the delivery of high quality and compliant clinical operations activities for all clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention Business Unit. The Associate Director, Clinical Operations is also responsible for direct and/or indirect management and development of the Clinical Operations Team, including Site Management & Monitoring, Clinical Safety Management and Clinical Field staff. In partnership with the team managers for Site Management & Monitoring, Clinical Safety Management and Clinical Field, the Associate Director, ClinicalOperationswill oversee organizational planning, resourceallocationand team development. The Associate Director, Clinical Operations will also act as a subject matter expert and team resource for BD global clinical procedures, templates and systems and willleveragethisexpertiseto lead and/or support process improvement initiatives where needed.

This job description is intended as a summary of the primaryresponsibilities ofand 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 berequiredeither now or in the future.

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

• Perform direct functional line management for the Site Management & Monitoring team manager(s), Clinical Safety Management team manager(s), Clinical Field team manager(s) and other Clinical Operations staff (as needed), including but not limited to, hiring, training/mentoring, resource allocation/assignments, performance and compliance assessments/reviews, recommending salaries and promotions, and implementing performance improvement plans and remedial actions, as needed.

• Plan and coordinate departmental resources for clinical operations activities.

• Oversee the allocation of clinical operations resources to ensure proper workload distribution and resources for ongoing projects and initiatives.

• Oversee the procurement and management of external clinical operations resources (e.g., consultants, CROs, etc.), as necessary, in support of business needs.

• Develop and oversee metrics reporting as needed for clinical operations activities to ensure that clinical operations staff meet or exceed project and functional timelines and deliverables. Provide regular and ad hoc reporting of metrics to Clinical Affairs leadership.

• Provide guidance, manage training assignments,identifytraining opportunities and work with managers todeterminereadiness of clinical operations staff to complete functional responsibilities.

• Conduct, attend, or support training and observational visits, as needed, to evaluate internal & external clinical operations staff.

• Oversee the quality and consistency of clinical operations team activities for all business unit projects 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.

• Review study-specific clinical operations team documents & deliverables, as needed, to ensure operational excellence and consistency.

• Provide feedback on other clinical study documents, as needed, and serve as a resource for the department tofacilitatea deeper understanding of clinicaloperations relatedprocedures.

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

• Coach and ensure successful relationships between clinical operations staff, investigational sitestaffand cross-functional study teams.

• Effectively communicate status updates for clinical operations activities to businessunit, Global Clinical Affairs and Global Medical Affairs leadership teams.

• Provide strategic direction as a subject matter expert in the assessment of relevantnew technologiesand global clinical procedures, as applicable. 

• Support continuousimprovementactivities/initiatives and sharing of best practices, including development of tools and resources for clinical operations activities.

• Provide support andallocateresources for internal or external audits/inspections and ensure resolution of audit/inspection findings related to clinical operations activities and staff.

• Review/approve expenses for clinical operations staff, as needed, and ensure compliance with company policies.

Education and Experience:

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

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

• 5+ years of experience in managing clinical projects and/or clinical operational activities involving site management & monitoring, clinical safety and clinical field support

• 3+ years of experience with direct people management​ (10-15 people)

• Excellent working 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.)

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

• Excellent interpersonal and communication (oral and written) skills

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

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

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

• Ability to travel up to 25% (or more during peak times)

Preferred Qualifications:

• MA/MS preferred in life sciences

• Experience with medical device studies (strongly preferred)​​

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

• Proficiencywith Veeva Vault Clinical Suite (CTMS, CDMS and eTMF)

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