Associate Director, Clinical Operations - Centralized Monitoring

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. 

Establish Risk-Based Quality Management and Centralized Monitoring processes corporately and for applicable clinical trials.

Review protocols to ensure the set-up, review and reporting requirements for KRIs and QTLs can be met and are standardized.

Provide technical oversight, guidance and coordination for all the central monitor activities.

Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions.

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.  

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. 

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.