Pfizer

Process and Standards Lead

Employer
Pfizer
Location
Remote, New York
Salary
Competitive
Posted
May 02 2021
Ref
4811568
Position Type
Full Time
Organization Type
Pharma
The Process & Standards Lead is a strategic Director role critical to the development of roles within Global Site and Study Operations and associated processes. The Process & Standards Lead influences clinical trial development and execution across GSSO.

The Process & Standards Lead is a Subject Matter Expert (SME) on processes within study start-up, study management, monitoring and oversight. The Process & Standards Lead supports ongoing processes but strives to identify continuous improvement opportunities, works with business lines to develop and drive role-based training and communication strategies.

The Process & Standards Lead serves as a point of contact for study management, monitoring and oversight standards, continuous improvement, issue escalation / resolution, inspection readiness / quality assurance, performance feedback, and review and management of metrics. The Process & Standards Lead oversees monitoring and assesses compliance at investigator sites, following up at an enterprise level when trends in monitoring practices are identified.

The Process & Standards Lead partners with the GSSO Leadership Team on rolling out and implementing new processes; assessing learning gaps and opportunities within the organization; identifying quality goals and standards for GSSO; and supporting a culture of high quality by creating, updating and improving tools used to facilitate consistency quality and transparency of site and study operations.

JOB RESPONSIBILITIES

Responsible for driving processes across Global Site and Study Operations:
  • Represent GSSO on SOP and process review, determines impact and provides recommendations or suggestions as needed.
  • Seek out, identify, and drive process improvements with a focus on standardization; the ability to work cross-functionally is critical to build consistency in standard processes.
  • Drive implementation of new and revised processes.
  • Provide frequent communications or clarifications for the entire Global Site and Study Operations organization.
  • Interface with Quality Center of Excellence and the Business Process Owner Network as point of contact for GSSO.
  • Champion the implementation and use of harmonized, consistent processes and excellence across GSSO deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.


Responsible for driving initial and ongoing training across Global Site and Study Operations:
  • Maintain the curricula for roles within GSSO (i.e., Study Manager, Site Oversight Leads, etc.) and for monitoring partners.
  • Partner with line representatives to maintain the shared platforms (i.e., GSSO Hub) across the roles within GSSO (i.e., Study Manager, etc.).
  • Partner with line representatives to develop and facilitate training and education for the groups and roles within GSSO.
  • Partner with line leadership to develop onboarding and ongoing training support for the groups and roles within GSSO.
  • May be involved in mentoring of others and building/sustaining a mentoring and buddying process and plan for all of GSSO.
  • Coordinate education sessions, as needed.
  • Coordinate the SME network.
  • Facilitate the sharing of functional area expertise and best practices within GSSO.
  • Serve as the initial point of contact and technical expert for questions about start up, study management, monitoring and oversight related processes, systems and responsibilities; may be required to primarily focus in one of these areas.
  • Partner with line leadership to assess learning gaps and opportunities needed within GSSO.
  • Interface with monitoring providers on training and processes.


Responsible for working cross functionally to drive consistency and efficiencies:
  • Partner closely with CSTL Process and Standards Lead to ensure alignment of process across operational functions.
  • Partner with stakeholders and functional lines to ensure understanding of process, change recommendations, and to gain consensus on business requirements.
  • Identify opportunities for process improvement / re-design in response to, but not limited to, compliance changes, external influences such as regulatory inspections, business strategy, performance signals, feedback from stakeholders, industry benchmarks.
  • Routinely assess and communicate process performance.
  • Serve as the process point person for inspections, audits and quality events and related trends, including compliance, readiness, support and remediation.
  • Assume point of accountability for all corrective and preventative actions arising from inspections, audits and quality events and related trends; demonstrate the learning culture by ensuring preventive actions are shared across assets in the portfolio to drive accelerated drug delivery.
  • Resolve escalated process issues and questions.
  • Serve as business point of contact for the analytics team: provides business context for required metrics / data.
  • Review metrics across the organization/enterprise/portfolio for trends and be the point of contact for metric remediations related to portfolio, study, and site levels metrics.
  • In strong collaboration with other colleagues or functions (Business Process Owners, Signal Interpretation Leads, project leads, and group leads).
  • Lead and/or participate in specific process improvement initiatives; monitor and report on implementation progress as appropriate.
  • Implement strategies to ensure consistent processes.
  • Represent GSSO by contributing to and/or leading cross departmental initiatives.


TECHNICAL COMPETENCIES
  • Ability to understand and assimilate high-level data and operational metrics and trends
  • Strategic thinking and targeted problem solving skills
  • Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers
  • Strong interpersonal skills
  • Establishes strong relationships with customers, strives to understand and meet customer requirements
  • Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards
  • Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures; motivates through example, commitment, loyalty and enthusiasm
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
  • Creativity and/or ability to put innovative approaches into practice in clinical development


QUALIFICATIONS / SKILLS

Training and Education

In general, candidates for this job would hold the following levels of education/experience:
  • Extensive global clinical trial/study and site management experience to SME level
  • Working knowledge of GCPs, monitoring, clinical and regulatory operations
  • BS - 8 years relevant experience
  • MS/PhD - 5 years relevant experience


Prior Experience
  • Demonstrated effectiveness working in a multidisciplinary, matrix team environment required
  • Demonstrated leadership on initiatives, integrations and process improvement workstreams
  • Evidence of Clinical Development and pharmaceutical study execution experience; thorough understanding of the processes required to operationally execute clinical trials (preferred)
  • Evidence of strong leadership, influencing, and negotiation skills


Skills
  • Understands how to work with multi-functional groups and teams to accomplish tasks
  • Ability to interpret study and site level data & translate and identify risks
  • Ability to proactively identify & mitigate risks around study execution
  • Ability to develop and deliver training
  • Country-level cultural awareness and strong interpersonal skills
  • Keen problem solving skills
  • Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)
  • Excellent communication skills, both written and verbal. Must be fluent in English


ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
  • Reports to Process, Standards & Signal Interpretation Group Lead
  • Coordinates with GSSO team members
  • Within GPD: Portfolio and Project Management, Operations Centre of Excellence, CPM CoE, BPOs in CSM, CDQ, and Biometrics.
  • Other Pfizer: Pharm Sci, Finance and Procurement, Legal, WSR.
  • Externally: Functional Service Providers, & Leadership/ Site Management, CRO Feasibility/Start-up and other 3rd party vendors.


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.

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.

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