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Clinical Project Manager

We Make Life More Rewarding and Dignified
Location: Libertyville¬ 
Department: Clinical¬ 


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Summary:


The Clinical Project Manager (CPM) is responsible for the execution of clinical studies from protocol development through final reporting in collaboration with the Global Clinical Affairs team.¬  The CPM is an expert in the operational delivery of clinical trials and brings that expertise to the design and conduct of clinical studies in alignment with business strategies. The CPM will be responsible for developing timelines and budgets for clinical studies and leading the execution of these studies according to time, cost and quality targets. The CPM is responsible for proactive operational risk management for clinical studies.¬  In this role, the CPM will regularly interface with key business stakeholders and team members across several functions, including Marketing, Regulatory, Market Access, R&D, Clinical Operations, Clinical Data Management and Statistics as well as external physicians, clinicians, research staff, and vendors. This role is responsible for coordinating study efforts both within the Company and through a variety of vendors.


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Responsibilities:


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  • Leads study teams; manages, facilitates and documents team meetings (e.g. meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making



  • Responsible for building and maintaining accurate study budgets and timelines.



  • With minimal supervision, plans and manages global clinical studies within budget, scope and timeline requirements.¬ 



  • Responsible for the execution of clinical studies from clinical protocol design to the final clinical study report.



  • Executes and communicates high quality, integrated cross-functional plans for clinical studies.



  • Leads development of clinical study protocols by working collaboratively with clinical affairs team and key stakeholders. Ensures supporting documentation (i.e. case report forms, monitoring plans, data management plans, etc.) support protocol objectives and operational efficiencies.



  • Provides study updates to senior clinical management, project stakeholders and to business unit/corporate management.



  • Actively tracks study data analysis and publication activities.



  • Ensures completion of timely clinical study reports for use by internal and external customers (e.g. core teams, discovery teams, and regulatory submissions).



  • Maintains strong relationships with study sites and clinicians.¬  May review reports and support resolution of issues related to external sites as needed in support of clinical study activities.



  • Act as mentor to clinical operations team members and has expertise in the operational delivery of a clinical study.



  • Effectively recruits, qualifies, contracts and manages Contract Research Organizations (CROs), as needed, to complete clinical studies.



  • Ensures regular review, summary and reporting of accurate clinical study progress to Global Clinical Affairs team, stakeholders, project teams, regulatory and marketing teams throughout the course of a study.



  • Communicates direction and updates to clinical study team members, assign tasks as appropriate, and ensure that commitments are met.



  • Proactively identifies study risks and works to mitigate them or create contingency plans.

  • Other duties as needed or required.

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    Requirements:


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  • 5-8 years of experience



  • Bachelor of Science Degree and a minimum of 5 years relevant experience



  • PMP (Project Management Professional) Certification a plus

  • Clinical project management track record with a working knowledge of project management tools and best practices (e.g., Microsoft Project)

  • Experienced in managing global clinical trials and in leading a clinical study team

  • Excellent communication skills, both written and verbal

  • Ability to progress a study with minimal guidance;¬  Initiative and drive for results

  • Demonstrated ability to collaborate and interact effectively on a cross-functional team (represent Clinical Affairs)

  • Experienced in the operational execution of clinical studies, including the management of study files

  • Experienced in CRO management

  • Demonstrated understanding of creating and communicating an accurate clinical budget

  • Organizational, leadership, risk identification and problem solving skills

  • Experienced in protocol development, study management, and study reporting



  • Sitting for extended periods of time.



  • Dexterity of hands/fingers to operate a computer keyboard, mouse, and other devices and objects.



  • Physically able to participate in and conduct training sessions, presentations, and meetings.

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Hollister is an EO employer ‚€“ M/F/Veteran/Disability
Job Req ID: 26990




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