Clinical / Scientific - Quality Assurance Manager - Pioneer Data Systems
Groton, CT 06340-5146
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in New Haven, CT or Groton, CT is currently looking for a Document Management Specialist to join their expanding team.
Job Title: Document Management Specialist / Clinical Trials Process
Duration: 22 months contract, extendable up to 36 months
Location: New Haven, CT or Groton, CT
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Candidates must be local to New Haven and/or Groton sites.
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 the both the Brussels and New Haven Pharmaceutical 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 Pharmaceutical Sponsor
ROLE RESPONSIBILITIES
Maintains an overview of existing procedural documents, both PCRU and Global
Triggers revision cycles as appropriate
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
Supports SMEs in the creation of new CMCDs, as appropriate
Ensures the PCRU CMCDs meet regulatory requirements, is designed with operational effectiveness in mind, and is harmonized across the PCRUs, when applicable
Manages the CMCD lifecycle; Manages the approval cycle, posting cycle and training cycle
Helps drive process improvements and adoption of global best practices
Works proactively with training representatives to support the roll-out of new and revised processes
Maintains a working knowledge of GCP/ICH Guidelines as well as all applicable regulations
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
PREFERRED QUALIFICATIONS
Project Management and inspection readiness experience strongly preferred
Comprehensive knowledge of GDMS and electronic signature processes
Process improvement / analysis / development experience
Continuous improvement methodology certification (e.g., Yellow Belt)
Comprehensive knowledge of ICH-GCP practice
A strong working knowledge and understanding of drug development processes
Interview: Teams
Shift/Hours: Monday - Friday first shift
What is the minimum education experience required?
Bachelor's Degree
2+ years of experience in procedural document management
Our client, a world-leading Pharmaceutical Company in New Haven, CT or Groton, CT is currently looking for a Document Management Specialist to join their expanding team.
Job Title: Document Management Specialist / Clinical Trials Process
Duration: 22 months contract, extendable up to 36 months
Location: New Haven, CT or Groton, CT
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Candidates must be local to New Haven and/or Groton sites.
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 the both the Brussels and New Haven Pharmaceutical 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 Pharmaceutical Sponsor
ROLE RESPONSIBILITIES
Maintains an overview of existing procedural documents, both PCRU and Global
Triggers revision cycles as appropriate
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
Supports SMEs in the creation of new CMCDs, as appropriate
Ensures the PCRU CMCDs meet regulatory requirements, is designed with operational effectiveness in mind, and is harmonized across the PCRUs, when applicable
Manages the CMCD lifecycle; Manages the approval cycle, posting cycle and training cycle
Helps drive process improvements and adoption of global best practices
Works proactively with training representatives to support the roll-out of new and revised processes
Maintains a working knowledge of GCP/ICH Guidelines as well as all applicable regulations
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
PREFERRED QUALIFICATIONS
Project Management and inspection readiness experience strongly preferred
Comprehensive knowledge of GDMS and electronic signature processes
Process improvement / analysis / development experience
Continuous improvement methodology certification (e.g., Yellow Belt)
Comprehensive knowledge of ICH-GCP practice
A strong working knowledge and understanding of drug development processes
Interview: Teams
Shift/Hours: Monday - Friday first shift
What is the minimum education experience required?
Bachelor's Degree
2+ years of experience in procedural document management
Source : Pioneer Data Systems
