Technical Resources International, Inc. · 1 day ago
Associate Director, Clinical Operations
Bethesda, MD
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expTechnical Resources International, Inc. is focused on clinical operations and is seeking an Associate Director to oversee clinical project management and site management activities. The role involves managing multiple drug development programs, ensuring compliance with regulatory requirements, and providing operational expertise to support clinical trial activities.
Data ManagementInformation Technology
Responsibilities
Oversight of clinical operations activities, including one or more of the following: clinical project management, clinical site management (essential regulatory documents, study start up, site monitoring), and/or clinical systems management (CTMS, TMF documentation review/ collection) with an understanding and working knowledge of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and scientific/ technical writing processes and requirements
Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse
Responsible for project management oversight for multiple functional areas within one or more complex drug development programs while managing deliverables within budget and to well-defined timelines
Effectively communicates in a matrix management organization with the ability to represent the clinical team during cross-functional collaboration
Provides operational expertise to support program/project level functional areas
Collaborates with Director and other departments and leads on clinical operations strategy and vision to support clinical trial activities
Informs division leadership on the overall status of clinical programs/projects and of potential issues/mitigation
Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays. Identify gaps and propose solutions to improve efficiency and quality of deliverables. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities
Support and comply with the company’s Quality Management System policies and procedures. Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed. Perform risk-based quality content reviews and monitor internal/external KPIs, as required by the client
Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development
Includes line management responsibility and staff hiring activities. Responsible for resource management, tracking, and level of effort projections for one or more groups in the clinical operations department and/or project functional areas
Participate in proposal writing for government and commercial clients, budget development, and bid defense meetings, as needed
Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up
Qualification
Required
Oversight of clinical operations activities, including one or more of the following: clinical project management, clinical site management (essential regulatory documents, study start up, site monitoring), and/or clinical systems management (CTMS, TMF documentation review/ collection) with an understanding and working knowledge of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and scientific/ technical writing processes and requirements
Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse
Responsible for project management oversight for multiple functional areas within one or more complex drug development programs while managing deliverables within budget and to well-defined timelines
Effectively communicates in a matrix management organization with the ability to represent the clinical team during cross-functional collaboration
Provides operational expertise to support program/project level functional areas
Collaborates with Director and other departments and leads on clinical operations strategy and vision to support clinical trial activities
Informs division leadership on the overall status of clinical programs/projects and of potential issues/mitigation
Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays. Identify gaps and propose solutions to improve efficiency and quality of deliverables. Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities
Support and comply with the company's Quality Management System policies and procedures. Drives innovative project and company performance improvement solutions, including corrective and preventive (CAPA) actions, as needed. Perform risk-based quality content reviews and monitor internal/external KPIs, as required by the client
Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development
Includes line management responsibility and staff hiring activities. Responsible for resource management, tracking, and level of effort projections for one or more groups in the clinical operations department and/or project functional areas
Participate in proposal writing for government and commercial clients, budget development, and bid defense meetings, as needed
Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up
Broad multidisciplinary understanding of the pharmaceutical clinical research and development processes with hands on regulatory, clinical operations, or clinical trial monitoring/management experience, e.g., clinical study design, conduct, management, reporting, and/or product development life cycle
Able to mentor staff and achieve high quality performance through risk management/ mitigation and implementation of corrective/ preventive actions, as needed
Strong facilitation, presentation, problem-solving, and conflict resolution skills; including ability to keep up with changing priorities, seasoned oral and written communications skills, strong attention to detail with ability to QC information, and experience in the use and development of clinical research databases/ systems/ tools
Strong leadership skills including change management, people development, strategic thinking, and influencing
Advanced ability to manage team resources to ensure attainment of department objectives
Expertise in Microsoft Word, PowerPoint, and Excel is required, and experience with Microsoft Project
10 years minimum experience in the pharmaceutical or biotechnology industry including Contract Research Organization (CRO) or other clinical trials or research environment, e.g., hands on regulatory, clinical operations (in-house CRA or study coordinator), site monitoring, or TMF experience, including at least 6 years of project management (PM) or equivalent clinical trials and operations management experience
Preferred
Proposal writing and bid defense skills a plus
Background in Infectious Disease/HIV clinical trials and/or Oncology; or experience in the conduct of Phase 1 protocols or prior work on a government contract, is a plus
Company
Technical Resources International, Inc.
Technical Resources International is a pharmaceuticals company offering biostatistics and clinical data management services.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase