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1+ months

Associate Director Clinical Operations

Kelly Services
New York, NY 10176
**Clinical Team Operations Leader, Associate Director (Remote)**


**(Business Operations)**


**Position Summary:**


The PDO Clinical Team Operations Leader (CTOL) reports to the Clinical Team Operations Director (CTOD) and supports the execution of the clinical operations strategy as defined by the Clinical Development Plan (CDP). The CTOL brings best in class project management capability to expedite key operational processes that include integrated clinical planning, governance/budgeting, resource management, cross-program risks and scenario planning. The CTOL partners with the Global Program Leader (GPL) to deliver the operational strategy according to quality, timeline, and budget goals set forth by the Compound Development Team (CDT).


**Principal Responsibilities:**


+ Partner with the GPL to expedite the management of clinical operational deliverables through application of integrated planning, best practices and project management capability.

+ Work with study level leads to capture, track and manage cross-program risks and issues and implement appropriate mitigation strategies.

+ Develop expertise on R&D and relevant TA governance processes and collaborate with clinical leaders and study managers to prepare deliverables required by associated stage-gate and TA Review Board processes and deliverables.

+ Build and maintain processes that will track and organize historical governance decisions and budget approvals as a resource to inform future governance planning efforts.

+ Support the GPL and Clinical Team to assist in the management of late-stage program processes including LTE transition and program closeout activities.

+ Partner with government and external partners to satisfy clinical objectives and advance the program as required.

+ Develop new CTOL capability and assist in the collection and dissemination of best practices that can be leveraged across the portfolio.

+ Support clinical teams by becoming a trusted advisor to project leadership and functional team members.

+ Assist GPL in making informed and timely decisions by applying specific combination of relevant experience, project management expertise, and leadership capabilities to facilitate clinical program execution.

+ Leverage expertise in project management tools and techniques, support the generation of project plans and provide insights based on customized project analysis and scenarios.

+ Bring clarity and focus to key clinical activities through critical path analysis; work with PMO partners to ensure alignment and integration with CDT project plans in Planisware.

+ Identify and communicate potential gaps in current cross-departmental processes and organizational structures and work with line management to remove obstacles to effective project execution.

+ Proactively recommend and outline new processes for upcoming and current clinical development phases. Help integrate enabling technologies into the team setting to drive clarity and efficiency.

+ Actively monitor and engage internal/external partners to ensure a constant awareness of emerging new practices, project management and leadership tools and strategies, and continuous improvement opportunities for CTOLs.


**Principal Relationships:**


+ Primary interfaces: Global Program Leaders, Global Trial Leaders, Program Management Leaders, Program Coordinator, Clinical Trial Leaders

+ Other Interfaces:

+ Contacts inside the company include but are not limited to:

+ Global Operations Head, Members of Compound Development Team, Finance, and Cross functional leads

+ Contacts outside the company:

+ vendors contacts as applicable, including CROs and external business partners as needed


**Education and Experience Requirements:**


+ A minimum of a Bachelors Degree or equivalent work experience is required, Post-Graduate degree in Project Management or Business is preferred

+ A minimum of **5 years industry/CRO/business experience is required in clinical drug development and/or clinical operations required** .

+ A minimum of **3 years of hands-on Project Managemen** t experience is required.

+ Professional project management certification (i.e. PMP, CPM, etc.) is preferred.

+ Demonstrated proficiency in **MS Project** is required.

+ Prior experience **leading cross-functional global teams** is required.

+ Demonstrated **ability to resolve conflict and influence teams without direct authority** is required.

+ Successful **experience in planning and management of governance processes** is required.

+ Proficiency with **technology-enabling tools including Visio, Excel** required.

+ Demonstrated ability to be creative and flexible to change/improve working environment in broad context is required.


\#ACRP


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-17 Expires: 2021-11-18

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Associate Director Clinical Operations

Kelly Services
New York, NY 10176

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