PCRU Process and Procedure Project Manager
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring for a PCRU Process and Procedure Project Manager.

Job Description:
The PCRU Process and Procedure Project Manager is dedicated to the management of the procedural documentation process. This role is responsible to manage the development, revision, harmonization, implementation, and maintenance of procedural documentation (standard operating procedures, work instructions, and all types of documents associated with procedures) related to Clinical Research Unit sites. This position:
• Manages the lifecycle of procedural documents across both the New Haven and Brussels sites.
• Maintains procedural documentation in a manner that supports corporate compliance and inspection readiness objectives.
• Provides additional support / assistance when needed and as agreed with Sponsor

Role Responsibilities:
o Maintains an overview of existing procedural documents, both PCRU and Global
o Triggers revision cycles as appropriate
o Collaborates with subject matter experts to identify changes or improvements required to procedural documentation based on regulatory changes, audit/inspection findings, business needs, or changes in industry standards
o Supports SMEs in the creation of new CMCDs, as appropriate
o Ensures the PCRU CMCDs meet regulatory requirements, is designed with operational effectiveness in mind, and is harmonized across the PCRUs, when applicable
o Manages the CMCD lifecycle; Manages the approval cycle, posting cycle and training cycle
o Helps drive process improvements and adoption of global best practices
o Works proactively with training representatives to support the roll-out of new and revised processes
o Maintains a working knowledge of GCP/ICH Guidelines as well as all applicable regulations
o Follows CMCD management and training procedures.

Basic Qualifications:
• Bachelor's Degree
• 2+ years of experience in procedural document management
• Enthusiasm for process improvement and document design; willingness to learn / adopt new ways of working
• Capability to collaborate with peers
• Knowledge of clinical trial operational processes and supporting systems and tools
• Familiarity with project management tools
• Strong written and verbal communication skills
• Experience working with 21 CFR part 11 (or equivalent) compliant document management / electronic signature software systems
PAY RANGE AND BENEFITS:
Pay Range*: $35-40/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

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