USACares Jobs

Job Information

BD (Becton, Dickinson and Company) Director Global Clinical Affairs, Monitoring Operations in Franklin Lakes, New Jersey

Job Description Summary

The Director of Clinical Monitoring Operations (a key leadership role within Global Clinical Affairs (GCA), will provide leadership, direction, and support to the clinical monitoring team. The team includes CRAs and project coordinators who are home based and/or office based. In addition, this role will oversee all US clinical monitoring activities and clinical monitoring team members and will have accountability for driving quality and timely results.

This role is also responsible for resource management and development for Clinical Site Management and Monitoring team members. In partnership with the GCA Leadership Team, the Director will lead the development, evaluation, and revision of internal clinical processes and procedures in accordance with CFR, ISO, EMA and ICH GCP rules and regulations. This role will lead internal BD monitoring teams supporting regulatory inspections.

This function is part of the GCA Central Teams and provides critical support to the Regional & Business Units (BUs) Medical Affairs (MA) teams. This role will sit on the GCA Leadership team to ensure strategic alignment and commitment to BDX Evidence Generation and Dissemination Strategy.

Job Description

The Director of Clinical Monitoring Operations (a key leadership role within Global Clinical Affairs (GCA), will provide leadership, direction, and support to the clinical monitoring team. The team includes CRAs and project coordinators who are home based and/or office based. In addition, this role will oversee all US clinical monitoring activities and clinical monitoring team members and will have accountability for driving quality and timely results.

This role is also responsible for resource management and development for Clinical Site Management and Monitoring team members. In partnership with the GCA Leadership Team, the Director will lead the development, evaluation, and revision of internal clinical processes and procedures in accordance with CFR, ISO, EMA and ICH GCP rules and regulations. This role will lead internal BD monitoring teams supporting regulatory inspections.

This function is part of the GCA Central Teams and provides critical support to the Regional & Business Units (BUs) Medical Affairs (MA) teams. This role will sit on the GCA Leadership team to ensure strategic alignment and commitment to BDX Evidence Generation and Dissemination Strategy.

The Director, works extensively with other GCA functional groups, including BU Leads, PMO, Safety, Stats and Alternative Data Solutions to support the execution responsibilities and integration of the evidence needs into the overall GCA portfolio.

Primary Responsibilities and Duties:

  • Oversee the development of comprehensive Clinical Monitoring Plans, monitoring tools, and / or other study related documents (e.g. Data Management Plan, Clinical Safety Plan, Safety Charters, Investigator Brochure (IB), ICF, etc.,)

  • Develop and Implement the Global Clinical Affairs centralized and risk-based monitoring approach in collaboration with GCA Leadership team

  • Contribute to the development and implementation of global Clinical Affairs projects, resources, timelines, strategies, and budgets

  • Identify training platforms and provide mentoring to Clinical Affairs Operations personnel and determine personnel readiness to complete various operational functions

  • Oversees assigned Clinical Research Associates (CRAs) and Project coordinators and serves as primary contact for CRAs regarding field issues.

  • Line Management duties for assigned CRAs e.g. conduct of staff performance appraisals, mentoring of less experienced staff members and routine / periodic review of workload allocated to staff members.

  • Evaluates performance of CRAs, including monitoring metrics, and provides feedback to CRAs, Project Managers and Senior Management.

  • Manage and assist CRA's and Lead CRA’s activities with project team members to ensure efficient clinical monitoring and effective project completion.

  • Develop, implement and assess the training program for Clinical Research Associates in compliance with ICH-GCP applicable regulations and industry standards.

  • Ensures most efficient utilization of CRAs to avoid conflicts and to maintain efficient deployment of resources. Escalate resourcing issues in real time.

  • Assists project management on monitoring questions/ issues and represents Global Clinical Affairs Leadership team and the monitoring team at relevant meetings.

  • Reviews monitoring plans, and monitoring templates for projects, provide input as needed.

  • Develop tools for monitoring performance and quality assessment.

  • Working with the Project Manager, acts as liaison between study site and the project team for monitoring- related issues at the study level.

  • Provide support to the Project Manager and BU Lead for clinical monitoring issues as required.

  • Ensure departmental and individual contributor compliance to the following:

  • All applicable BD standards, procedures, and Guidance documents

  • All applicable regulations (i.e. FDA and ISO) and Good Clinical Practice guidelines, as applicable

  • Empower Site Management and Monitoring team members to proactively identify potential issues, propose solutions, and address any gap or potential deficiency within the conduct of a clinical study

  • Lead efforts to define and streamline Clinical Affairs Operations and functions through collaboration with Corporate and Business Unit cross functional teams as appropriate, and/or implementation and revision of Standard Operating Procedures (SOPs) and Work Instructions

  • In collaboration with Clinical project teams, oversee CROs and Vendors for outsourced services in support of monitoring activities

  • Develop and maintain collaborative working relationships with stakeholders and other groups as necessary to achieve stated business objectives

  • Provide support and expertise on the design and development of clinical study documentation such as clinical protocols, ICFs, Annual Reports, CSRs, Case Report Forms (CRFs), and template clinical study documentation

Education/Degree

  • Bachelor’s degree required, with advanced degree strongly preferred (e.g., MS, MPH, MBA, PhD, PharmD, MD).

  • Minimum 12 years of relevant experience in pharmaceutical or medical device clinical development preferred, to include management of large, complex projects while successfully establishing and implementing functional strategies across organizations

  • Minimum 10 years of experience monitoring, leading, and developing individuals and organizations and managing resources across multiple competing projects preferred.

  • Demonstrated excellence in centralized and risk-based monitoring approaches within complex portfolio development

  • Strong Proficiency in and knowledge of:

  • 21 CFR 11, 50, 54, 56, 320, 812, 820-C

  • ICH-E6: GCP & ISO 14155

  • CTMS; EDC; EMR; eTMF; IVRS

  • Microsoft Office Suite including Project, One Note, SharePoint & TEAMs

  • Demonstrated ability to establish and lead a successful global functional team.

  • Demonstrated ability to establish and build successful collaborations/liaisons with internal peers and senior management across multiple disciplines, businesses, regions, and organizational levels.

  • Demonstrated ability to work well independently as well as a member of multiple, integrated teams

  • Strong project planning, project management, leadership, negotiation, writing and presentation skills as well as an ability to contribute creative yet practical solutions to problems

  • Comprehensive knowledge of clinical study design and strategy for IDE, Post Market, Biospecimen, and Diagnostic clinical studies.

  • Ability to make decisions with limited data and work effectively in a rapidly changing and ambiguous environment.

  • Travel is estimated to be <30%, US and internationally

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

DirectEmployers