Job Description

Overview

The Process & Standards Lead is a strategic 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, developing and driving initial and ongoing training and communications.
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 ensures 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.

Responsibilities

Responsible for driving processes across Global Site and Study Operations:
\xef\x82\xb7 Represent GSSO on SOP and process review, determines impact and provides recommendations or suggestions
as needed.
\xef\x82\xb7 Seek out, identify, and drive process improvements with a focus on standardization; the ability to work crossfunctionally is critical to build
consistency in standard
processes.
\xef\x82\xb7
Drive implementation of new and revised processes.
\xef\x82\xb7 Provide frequent communications or clarifications for the entire Global Site and Study Operations organization.
\xef\x82\xb7
Interface with Clinical Development Quality (CDQ) and the Business Process Owner Network as point of contact
for GSSO.
\xef\x82\xb7 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:
\xef\x82\xb7 Maintain the curricula for roles within GSSO (i.e., Study Manager, Site Oversight Leads, etc.) and for monitoring
partners.
\xef\x82\xb7 Maintain the Educators and Accelerators across the roles within GSSO (i.e., Study Manager, Site Oversight
Leads, etc.).
\xef\x82\xb7 Develop and facilitate training and education for the groups and roles within GSSO.

\xef\x82\xb7 Provide onboarding and ongoing training support for the groups and roles within GSSO.
\xef\x82\xb7 May be involved in mentoring of others and building/sustaining a mentoring and buddying process and plan for
all of GSSO.
\xef\x82\xb7 Coordinate education sessions, as needed.
\xef\x82\xb7 Coordinate the SME network.
\xef\x82\xb7 Facilitate the sharing of functional area expertise and best practices within GSSO.
\xef\x82\xb7 Serve as the initial point of contact and technical expert for questions about study management, monitoring
and oversight related processes, systems and responsibilities; may be required to primarily focus in one of
these areas.
\xef\x82\xb7 Assess learning gaps and opportunities needed within GSSO.
\xef\x82\xb7 Interface with monitoring providers on training and processes.
Responsible for working cross functionally to drive consistency and efficiencies:
\xef\x82\xb7 Partner closely with CPM Process and Standards Lead to ensure alignment of process across operational
functions.
\xef\x82\xb7 Partner with stakeholders and functional lines to ensure understanding of process, change recommendations,
and to gain consensus on business requirements.
\xef\x82\xb7 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.
\xef\x82\xb7 Routinely assess and communicate process performance.
\xef\x82\xb7 Serve as the process point person for inspections, audits and quality events and related trends, including
compliance, readiness, support and remediation.
\xef\x82\xb7 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.
\xef\x82\xb7 Resolve escalated process issues and questions.
\xef\x82\xb7 Serve as business point of contact for the analytics team: provides business context for required metrics / data.
\xef\x82\xb7 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.
\xef\x82\xb7 Other interfaces
o In strong collaboration with other colleagues or functions (Business Process Owners, Signal
Interpretation Leads, project leads, and group leads):
\xef\x82\xa7 Represent GSSO by contributing to and/or leading cross departmental initiatives.
\xef\x82\xa7 Implement strategies to ensure consistent processes.
\xef\x82\xa7 Lead and/or participate in specific process improvement initiatives; monitor and report on
implementation progress as appropriate.

Qualifications

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 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

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 \xe2\x80\x93 8 years relevant experience
• MS/PhD \xe2\x80\x93 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

ICON