Pfizer Pfizer Clinical Research Units Standard Operating Procedures & Training Lead, Sr. Manager in Groton, Connecticut

The (PCRU) Standard Operating Procedures (SOP) & Training Lead will have responsibility for 2 distinct areas:

1) SOP Program: Lead the development, revision, harmonization, implementation and maintenance of procedural documentation (standard operating procedures, work instructions and all types of documents associated with SOPs and Work Instructions) related to Pfizer Clinical Research Units. This would include determining effects of global procedures on the PCRU as well.

2) Training Program: Implementing the end to end training and ongoing learning needs of the PCRU's Training Strategy. Dedicated to planning, developing and executing the training program for the Pfizer Clinical Research Units. Their focus is to increase compliance and awareness through various training techniques in the areas of ICH/GCP, policies, procedures, specific equipment, specialty techniques, etc. by collaborating with colleagues across Pfizer.

SOP Specific:

  • Maintains overview of existing procedural documents, both PCRU and Global

  • Triggers revision cycles as appropriate

  • Collaborate 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

  • Lead a team of global subject matter experts in the development or revision of procedural documentation using process design and project management principles

  • Supports SMEs in the creation of new documents, as appropriate

  • Ensure the documentation produced meets regulatory requirements, is designed with operational effectiveness in mind, and is harmonized across the PCRUs, when applicable

  • Manages the approval cycle, posting cycle and training cycle

  • Helps drive process improvements and adoption of global best practices

  • Work proactively with training representatives to develop training strategy including recommending curricula assignments, materials development and communications required to support the roll out of revised processes

  • Manage queries from the organization related to assigned policies/SOPs

  • Maintain procedural documentation in a manner that supports corporate compliance and inspection readiness objectives

  • Assist in audit coordination/conduct and inspection support/follow-up, as required, in collaboration with PCRU Quality Compliance Manager

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

  • Is a QMS04-GSOP expert

Training Specific:

  • Manages the development of training and coordinates training activities across the CRU groups, ensuring global best practices are identified and maintained across both CRU sites.

  • Effectively partners with CRU groups in the development and implementation of their Job Function Curricula, including training

  • materials to ensure consistency of on-the-job training processes.

Leads and coordinates the effort for the development and implementation of:

  • Global training initiatives

  • Training for new/updated systems

  • Specific training needs resulting from GCP incidents/protocol deviations

Collaborates across the GPD organization to standardize training practices, gain efficiencies in training system focus areas such as documentation, promote effective training practices, and define metrics for learning.

Creates required training (including web-based or instructor-led sessions) for SOPs. Works with the SOP manager to ensure appropriate people are assigned in P2L.

Coordinates and continues to improve:

• CRU Orientation Program for new hires

• Train the Trainer Program

Analyzes and assesses training effectiveness to determine when revisions, enhancements, or new programs should occur, and receives recommendation / input from team. Provides input to business stakeholders on the analysis

Develops evaluations to measure training effectiveness and provide metrics for management review. Report monthly analytics like - knowledge assessment scores, in clinic effectiveness scores, overall proficiency scores

Acts as the primary coach for those individuals assigned as trained trainers/preceptors.

Coordinates external training for global or site specific needs.

Manages training documentation.

Provides P2L expertise to the CRU organization.

Functions as Training Subject Matter Expert for Regulatory, Corporate and BOH audits/ inspections

Experience

Candidates for this job should have the following levels of education and relevant experience:

  • Bachelor's degree and 12 years' experience or a Master's Degree with 9 years' experience

  • A scientific or technical degree is preferred

  • SOP Management and implementation background required

  • Experience in developing training programs

  • Experience with inspection readiness

  • Comprehensive knowledge of ICH-GCP practice

  • A strong working knowledge and understanding of drug development processes

  • Strong verbal, written, presentation, technical, and interpersonal communication skills

  • Knowledge of training principles, facilitation and measuring training effectiveness

  • Candidate needs to possess a skill for Training with passion & energy

  • Should be able to work with people, make things happen & get things done

  • Should have financial awareness regarding budget estimates and costs

  • Finance awareness: ability to develop training budget estimates and justify costs

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Additional Offer Details:

Grade: 11

Additional Locations: New Haven, CT, Brussels, Belgium

Eligible for Employee Referral Bonus

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.