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Snr Clinical Trial Manager

San Diego Metro Area, California

Post Date: 06/28/2017 Job ID: JN -062017-19399
Snr or Principal Clinical Trial Manager - BS or Advanced degree & 10+ years of experience in clinical trial management required.
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 the organization.
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
Leading/driving collaboration with CRO partner(s) for program operational delivery to ensure meeting expected timelines, budget, and quality in alignment with Celgene expectations and standards
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
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

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

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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