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Principal Clinical Trial Manager Auburn United States,  

Aequor Technologies (company)

Posted on : 22 December 2017

Project Description

Principal Clinical Trial Manager (Contractor)

Position Description:

The Principal Clinical Trial Manager provides leadership and oversight of the clinical research program(s) to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. Responsibilities include providing strategic operational direction, execution of complex study(ies) and/or oversight of multiple cross-functional study team(s) and performance and quality oversight of the associated Contract Research Organization (CRO) teams. They should be able deliver high caliber presentations to senior and executive leadership within and outside of Client (as appropriate). The Principal clinical trial manager is expected to consistently demonstrate strategic critical thinking skills for problem solving and have the lateral and insightful thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.

The Principal clinical trial manager has overall accountability for the execution of the Clinical Operations strategy for the program(s) and /or studies which may include but is not limited to the following

Responsibilities and Duties:

Program Management
" Provision of guidance on operational program implementation and management
" Accountable for ensuring that program-specific standards are developed and applied across trials [in line with portfolio-level standards] to ensure consistency and efficiency
" Driving the operational program strategy in close interaction with CRO partners
" Active contribution to the scientific and operational feasibility as well as oversight and alignment of activities of the internal and external operational team members contributing to the program
" Reports to senior management as needed with regards to all matters of clinical program implementation
" Leading/driving collaboration with CRO partner(s) for program operational delivery to ensure meeting expected timelines, budget, and quality in alignment with Client expectations and standards
" May represent Clinical Operations within the global project team

Financial Planning and Project Management
" Drive the early planning of study / program timelines and budgets through close collaboration with other functions (e.g. Clinical, Clinical Trial Analytics, PSRM, Finance, Data Management, IMSC and other relevant functions)
" Takes ownership and accountability for development and management of study and/or program level budgets
" Collaborate closely with Project Leadership to ensure that timelines and budgets are appropriately presented to governance committees.
" Notify Clinical Trial Management Leadership (and other relevant functions) of resource requirements for new studies
" Support identification and resolution of issues related to study timelines and budgets
" Lead regular (e.g. quarterly) program budget review meetings with Finance and ensure that anticipated budget deviations are flagged.
" Review study planning and tracking tools regularly (including study budgets), flag deviations to relevant stakeholders and develop mitigation plans in collaboration with Clinical Trial Managers and other relevant functions
" Development/management/reconciliation of overall program budget(s) or oversight thereof
" Development/management/reconciliation of CRO partner scope of work (SOW) per contract, quality, and budget
" Oversight of review/approval of clinical service provider (vendor) invoices and management of accruals and SOW changes.
" Oversight of program execution utilizing available performance metrics and quality indicators
" Oversight of development and management of key program milestones and deliverables through collaboration with internal and external stakeholders
" Proactive identification/assessment of potential risks at program level and oversight of development/implementation of actions to avoid or mitigate
" Oversight of the maintenance/updating of data as appropriate in study management tools including CTMS
" Informing leadership (as appropriate) on overall clinical program progress, updated forecasting, and of potential issues/mitigation
" Excellence in identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.

Program Planning and Conduct
" Operational input into program and study level planning and documents as appropriate
" Development [in collaboration with CRO partner] of innovative clinical operation strategies (such as patient access, recruitment, and retention) at the program level
" Oversight of clinical service provider (vendor) selection, specification development, and management.
" Oversight of development/implementation of program-specific training for program/study teams, investigational sites, and vendors

Relationship Management
" Development/maintenance of collaborative relationships with:
o internal partners/stakeholders including Clinical Research, CR&D Operations, Affiliates and Project Management
o external partners including Contract Research Organizations (CROs), Academic Research
o Organizations (AROs), and other clinical service providers

Continuous Improvement
" Collaborate with colleagues within Clinical Operations and from other Departments to maximize efficiencies, share and apply best practices
" Flag potential process improvement opportunities and support execution
" Expected to lead continuous improvement or other departments or cross-functional initiatives.

Line management
" May be responsible for oversight of one or more contract Clinical Trial Managers
" Other responsibilities as assigned.

Minimum Requirements:

" BA / BS, Advanced degree preferred
" Degree in relevant discipline
" Minimum of 10 years clinical research experience including all aspects of clinical trial planning and start up (including budget & resource planning), and in executing a wide range of clinical trial activities, from start up through final study report
" At least 6 years clinical study management experience with
" At least 4 years direct multinational study management experience
" Minimum of 4 years of experience in oversight of CRO study execution
" Recognized as a technical Expert in the operational execution of the studies
" Clinical trial project management skills
" Financial budgeting and forecasting skills
" Leadership / influence management skills
" In depth knowledge of ICH/GCP, regulatory guidelines/directives, and clinical research processes
" Disease/Therapeutic knowledge and expertise is highly desirable
" Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial/marketing)
" Solid Therapeutic Drug Development expertise for the assigned program
" Understanding of cross-functional components of the operationalization of trials to integrate input from internal and external team members into the clinical operation strategy
" Ability to lead a global, cross-functional virtual team
" Ability to lead and drive program planning and delivery in collaboration with CRO partners
" Time management skills  ability to effectively multi-task and prioritize
" Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation and execution
" Demonstrated success in using oral and written communication skills to influence, inform, or guide others
" Solid computer skills  requirement of MS applications including (but not limited to) MS Project, Word, Excel
" Study Tools including electronic system skills  CTMS / EDC

Key Leadership Competencies:
" Creates realistic plans that clearly define goals, milestones, responsibilities and results
" Maintains focus on strategic objectives while accomplishing operational goals
" Places a priority on getting results with an emphasis on high quality outcomes
" Holds self and others accountable for accomplishing goals
" Makes timely, data-driven decisions
" Develops and maintains effective working relationships with people across cultures
" Encourages and supports collaboration across teams, functions, and geographies
" Ensures that conflict is handled constructively so that performance is not impacted
" Displays a willingness to challenge the status quo and take risks
" Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute
" Maintains optimism and composure in times of change, uncertainty, or stress



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