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Description We are offering a long term contract employment opportunity for a PCRU Process and Procedure Project Manager, in the industry of clinical research, based in Peapack, New Jersey. You will be entrusted with the management of procedural documentation processes, harmonization, and implementation of standard operating procedures across multiple sites.

Responsibilities:

• Oversee the lifecycle of procedural documents across various sites, ensuring consistency and effectiveness.

• Maintain procedural documentation in a manner that supports regulatory requirements and corporate compliance.

• Collaborate with subject matter experts to identify necessary changes and improvements in procedural documentation based on audit findings, regulatory changes, business needs, or changes in industry standards.

• Support the creation of new documentation as needed and ensure that they meet regulatory requirements.

• Manage the approval cycle, posting cycle, and training cycle of procedural documentation.

• Proactively work with training representatives to support the roll-out of new and revised processes.

• Maintain a working knowledge of GCP/ICH Guidelines as well as all applicable regulations.

• Drive process improvements and adoption of global best practices.

• Assist in additional tasks as agreed upon. Requirements • Demonstrated expertise in project management, specifically in the field of clinical trial operations

• Knowledge and experience in implementing best practices, procedures, and process improvements

• Proficiency in documentation, document management and creating standard operation procedures

• Experience in audit procedures and compliance functions, adhering to industry standards and regulatory requirements

• Ability to effectively communicate with team members, stakeholders, and subject matter experts

• Proven experience in providing training and workstation support

• Skilled in software systems and consumer electronics relevant to the role

• Track record of driving continuous improvement and implementing changes based on audit findings

• Experience in clinical trials and understanding of clinical trial methodology

• Ability to develop a rollout plan for new procedures and processes

• Understanding of triggers within project management and ability to respond effectively

• Strong commitment to corporate compliance and ethical business conduct

• Ability to work collaboratively with various teams to ensure process and procedure alignment.

Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.

All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

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