Trial Operations Team Leader
Company: Principia Biopharma Inc.
Posted on: June 10, 2021
The TO Team Leader (TOTL) lead and manage a team of Global Study
Managers (GSMs) and Study Data Managers (SDMs). The TOTL support
his/her sub-group as the single Trial Operations (TO) point of
accountability for the operational delivery of clinical studies /
The TOTL is responsible for the direct line management of, and
for ensuring the training, coaching, motivation and development of
individuals allocated to his/her sub-group to maximize their
capabilities, performance, and overall utility.
The TOTL assists Trial Operation TA Head with CSO-TO resource
management to ensure alignment according to risk adjustment,
competencies, and expertise and project milestones while
seeking-out synergies for resource optimization.
The TOTL is accountable to drive and support his/her sub-group
for planning and delivering strong operational plans for study
execution with implementation of best practices, standards for
trial/data-management and risk management.
The TOTL is responsible for ensuring program operational
consistency, alignment and identifying synergies for all studies /
- The TOTL participates in global harmonization and optimization
of operational processes and standards and fosters innovation and
continuous improvement; the TOL drives implementation within
his/her subgroup with a high level of team spirit in collaboration
with other responsible and accountable key interfaces and CSO
Lead team of Global Study Managers (GSMs) and Study Data
Managers (SDM) and support his/her sub-group as the single TO point
of accountability for the operational delivery of clinical studies
(timelines, budget and quality)
Understand the business strategy and objectives for clinical
programs managed by his/her sub-group. This includes understanding
and planning how different studies fit together (e.g. how the
readout from a study informs the next steps and overall program
Define with the GSM and SDM (in collaboration with PLs)
operational strategy to support the project needs and best in class
Support GSM and SDM to develop and execute strong operational
plans to successfully deliver studies /programs on time, within
budget and meeting quality targets.
Support GSM to develop a strong financial plan to minimize
change orders through understanding of external vendors, 3rd party,
and internal costs.
Ensure robust oversight plans across program and monitor
adherence; maintain program level vendor meetings as needed to
further secure harmonization, vendor deliverables.
Provide Project Management expertise to support GSM and DM in
critical path management, risk identifications, mitigation plan
definition and implementation.
Maintain day-to-day oversight of his/her sub-group execution and
performance to meet agreed upon deliverables.
Proactively monitor, anticipate and re-mediate issues to ensure
continued alignment and delivery of clinical milestones.
Ensures process consistencies in the operational development and
Identify synergies to optimize TO project/study team
Ensure product/indication specific therapeutic & regional
parameters are identified and standardized within the
product/indication. Ensure program consistency & consolidation in
response & remediation to audit observations.
- Build inspection readiness mindset in the team and ensure
oversight of the preparation and responses to audit/inspection
reports for finding associated to GSM.
Manage and develop people:
Ensure performance and development cycle is completed for all
member of his/her team: set priorities, identify people skills,
needs, support his/her sub-group to develop Individual Development
plan, and provide regular performance feedbacks.
Coach individuals on the deep understanding of the day to day
By exchanging with her/his peer, identify opportunities for
people to "right fit" for business and personal success, leveraging
Headcounts towards priority projects to drive operational
Share the strategic vision of the organization to his/her
sub-group, being open and aware to his/her environment.
- Handle administrative activities (e.g. labor time, travel, and
expenses review and approval; use of required Management reporting
tools/systems, etc.) in accordance with corporate and departmental
Ensures Clear, Concise, Consistent and Timeline
At project level, actively participate in meetings as relevant
(e.g. Division / Unit level meetings, CSO Project Teams meetings,
Safety Monitoring Team meetings, etc.)
Ensure communication and alignment with Project Leaders and TO
Therapeutic Area Head.
- Interact with counterparts in other CSO functions and
contributes to actions that can limit the silos within Trial
Operations and its stakeholders.
Assists TO Therapeutic Area Head in resource management:
Provide feedback to TO Therapeutic Area Head regarding
individual resourcing considerations for skill-set and study team
alignment considerations and in collaboration with other TOLs
regarding resourcing needs vs actual workload, risk assessment,
timelines and budget.
Define clear assignement for each individual in her/his
- Identify opportunities for resources optimization.
Promote global harmonization, simplification and optimization of
operational processes and standards and fosters innovation and
continuous quality /process improvement:
Fosters a productive team environment aligned with CSO-TO
Mission and Objectives.
Identifies opportunities to streamline processes and reduce
Act as a change agent, driving change and implementation of new
approaches and standards within his/her sub-group, with a high
level of team spirit and motivation.
Ensures consistent, timely and appropriate circulation of
Participates in the development of global SOPs, policies,
guidelines or related tools via participation in working groups and
collaboration with Transversal Services.
- Identify and communicate lessons learned, ensure
cross-fertilization and knowledge sharing to all clinical
Knowledge And Skills:
Strong Trial Management and/or Data Management expertise.
Strong project management skills and experience.
Effective people management and leadership skills.
Ability to align with and implement management decisions;
ability to motivate a team to maintain a high level of team spirit
in support of management decisions/directions.
Strong interpersonal, negotiation and communication skills
(verbal and written) including a customer focus mentality.
Strong organizational skills, flexibility, efficiency in matrix
organization, strong ability to effectively handle large
complicated global projects.
Business Acumen skills: keenness and quickness in understanding
and dealing with a "business situation" (risks and opportunities)
in a manner that is likely to lead to a good outcome.
Experienced in successful vendor management and oversight.
Strong ability to analyze data and report metrics to monitor
trends, identify issues for timely mitigation.
Ability to effectively serve as a change agent.
Adequate level of understanding of clinical data management
systems, database and programming concepts, database structures,
and file structures.
Knowledge of company tools, processes and SOPs.
Strong working knowledge of Microsoft Office.
Knowledge of international regulations / standards (e.g. GCP,
CDISC, ICH guidelines, FDA NDA etc.).
Knowledge of local Human Resource regulations.
- Strong English skills (verbal and written) i.e., ability to
exchange fluently (incl. negotiation).
Knowledge And Skills Desirable But Not Essential:
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and
Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we
operate and embedded in our Core Values. We recognize to truly tap
into the richness diversity brings we must lead with inclusion and
have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
Keywords: Principia Biopharma Inc., Cambridge , Trial Operations Team Leader, Other , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!