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Trial Operations Team Leader

Company: Principia Biopharma Inc.
Location: Cambridge
Posted on: June 10, 2021

Job Description:

Position Overview:

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 / programs.

  • 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 / programs.

  • 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 functions.

Key Responsibilities:

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 strategy).

  • Define with the GSM and SDM (in collaboration with PLs) operational strategy to support the project needs and best in class CMR metrics.

  • 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 execution.

  • Identify synergies to optimize TO project/study team organization.

  • 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 operational activities.

  • 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 success.

  • 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 guidelines/policies.

Ensures Clear, Concise, Consistent and Timeline Communication:

  • 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 sub-group.

  • 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 trial complexity.

  • 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 updated information

  • 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 operational teams.

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).

Basic Qualifications:

  • Bachelor's degree in relevant scientific and/or medical field and a minimum of 8 years' experience in clinical research in pharmaceutical industry.

  • Successful experience in management of complex studies/programs.

Knowledge And Skills Desirable But Not Essential:

  • Experience in relevant therapeutic area(s).

  • Prior managerial experience preferred.

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 all.

Keywords: Principia Biopharma Inc., Cambridge , Trial Operations Team Leader, Other , Cambridge, Massachusetts

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