Clinical Study Team Lead - FSP

Parexel FSP is looking for multiple experienced Clinical Study Team Leads(CSTLs) in Brazil, Mexico, and Argentina!

Job Summary

The Clinical Study Team Lead (CSTL) is the single point of accountability forinput into studydesigntoensure feasibility of execution, planning and delivery of clinical studies on time, within the approvedbudget and with quality.

The CSTL is a Clinical Development expert focused on the execution of clinical trials and brings thatexpertise to the design & conduct of clinical studies in alignment with the program and portfoliostrategiesfor the specific category(ies)/Therapeutic Areas.

The CSTL is an experienced project manager and matrix leader accountable for leading the study teamdelivery of multiple complex global studies and/or programs.

The CSTL is responsible for developing clinical trial timelines and overseeing budgets for their clinicalstudies.

The CSTL will partner and collaborates with functional line leadership to ensure optimal resourcing of thestudy team.

The CSTLis responsible for proactive risk managementand inspection readinessfor their clinical study(ies).

The CSTL may lead the delivery of Module 2 and 5 deliverables to support market authorizations. The CSTL may work at the program level.

When working at the program leveltheCSTLis accountable for developing the executionstrategy and managing the timelines, budgets, and quality acrossmultiplestudies in the program.

Role Responsibilities:

Study TeamLeadership

• Leads the study team and associated deliverables across all functions; accountable for managing anddriving overall study timelines, budgets and quality targets to meet or exceed business needs

• Accountable to ensure effective study team scheduling, records and communications in partnershipwiththeCTA

• Accountable for strategic planning and decision making at the study level in line with programobjectives

• Accountable for issue resolution

• Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and accountable for effective study team operations

• Leads study team chartering and team health check process

• Partners and collaborate with functional line leadership to ensure optimal resourcing of the studyteam

• Represents the study team at appropriate medicine team and sub-team discussions

• Escalates issues to Clin Ops Head when study team has been unable to resolve or adequatelymanage/mitigate

Quality Oversight

• Drives themonitoring and remediation of quality metrics and completion of the remediation tracker

• Drives functional lines to ensure inspection readiness

• Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log

• Maintains active awareness and appropriate escalation of all Significant Quality Events (SQEs) reportedfor study and ensures appropriate prioritization and management of events through to resolution

Study Metrics & Reporting

• Acts as a single, authoritative source of study information andleads study level status reporting perorganizational norms and expectations

• Ensures systems are maintained with up to date program status, risks, and issues

• Oversees operational metrics across study and partners with functional lines to manage trends

Risk Management

• Leads the study team in the management and communication of risk management plans including riskassessment and mitigation strategies

• Proactively identifies operational issues and leads the team in identifying options to de-risk andcapitalize on opportunities

• Ensures study risk planning is ongoing throughout the study

• Leads the study team in proactive problem solving and risk management

Governance & Decision Points

• Drives the proactive planning to navigate the team through governance and decision point milestonesto support on-time delivery of study deliverable on-time to maintain development timelines

• Leads preparations for and presents the study to relevant governance per organizational norms andexpectations

• Ensures Quality Gate timing planning, and team readiness

In some instances, the CSTL may support the following activities:

Business Development

• A member of the due diligence team for business development opportunities.Partner with leaders to assess development program timelines andbudgets to inform the assessment ofopportunities for the category

Submissions

• Leads cross functional Module 2/5 submission sub-teams with accountability for delivery and anoverall operational strategy

• Develops and leads execution of the data and document delivery plans at key milestones such as POC,DP3 decisions, submissions, and rapid response. Manages other submissions activities as necessary

• Accountable for managing overall submission Clinical Development sub-team timelines, budgets, and quality targets

• Accountable for building, forecasting, and managing the Clinical Development submission budget

• Oversees operational metrics across submission sub-teams and manages trends and escalations

• Ensures comprehensive operational input to submission plan

QUALIFICATIONS

Training and Education Preferred:

• Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of theprocesses associated with project and study management, knowledge of Good Clinical Practices(GCPs), monitoring, clinical, and regulatory operations

• Bachelor’s degree in one of the disciplines related to drug development or business required.Advanced degree desirable

• Preferred 10 or more years of relevant experience

Prior Experience Preferred:

• Broad experience in a Clinical Trial Execution discipline(e.g. senior study management expertise, leaddata management expertise, clinical leadership expertise)

• Demonstrated project management and cross-functional leadership experience

• Experience in understanding of key drivers impacting budgets and experience building a Clinical TrialBudget and managing project to budget

Skills:

• Strategic thinking and targeted problem-solving skills

• Ability to lead cross-functional teams, identify, resolve & escalate issues

• Project management expertise

• Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery

• Ability to represent & communicate clearly to senior leaders and governance bodies

• Ability to understand and assimilate high-level data from all functions

• Strong communicationand interpersonal skills