Job Description

The Program Manager, Global Investigator Initiated Trials (IIT) reports directly to (TBD) and collaborates closely with the Global and Regional Leads of Clinical Affairs and regional IIT Administrators – and will be primarily responsible for managing, implementing, and maintaining oversight of all administrative aspects of the global Investigator Initiated Trial (IIT) program.

Job Duties

• Formulate, organize, and monitor the Global Olympus IIT Program.

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  Decide on appropriate strategies and objectives.

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  Establish and optimize processes and procedures to ensure effective cross-functional communication and program adherence with Olympus scientific objectives and research priorities.

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  Organize, prepare, and follow-up of Global IIT Review Board Meetings and utilize the IIT Portal accordingly.

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  Act as the global contact person for all regions, CPMs and Global IIT Review Board members as far as the Olympus IIT program is affected.

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  Oversee and uphold standard for the IIT program ensuring process adherence to Olympus policies, procedures, and work-instructions.

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  Serve as owner and subject matter expert for the Olympus IIT Portal including opening and resolving tickets with external vendor, establishing and managing user profiles, and maintaining user guides and training materials.

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  Implement process rigor including acceptance criteria, fair market value assessment, and adherence to applicable board requirements.

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  As appropriate, liaise between investigators, regional cross-functional partners, and global cross-functional partners, including the regional IIT administrative staff throughout study process from submission to completion.

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  In collaboration with applicable regional IIT administrators and HCP-CM, support the contracting process and coordination of supply planning including regional logistics of importing/ordering with cross-functional collaborators as appropriate

Job Requirements

REQUIRED QUALIFICATIONS:

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  BA/BS Degree in life sciences, or related field or combination of other BA/BS and minimum of 5 years of relevant medical device/life sciences/pharmaceutical industry experience.

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  Minimum of 5 years previous experience with medical device trials, serving as a clinical study coordinator, or site manager.

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  Minimum of 4 previous experience overseeing IIT programs.

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  Strong computer skills with proficiency with MS Windows-based applications.

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  Working knowledge of ICH Good Clinical Practice guidelines.

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  Working knowledge of fraud and abuse laws and regulations applicable to the medical device and/or pharmaceutical industries.

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  Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.

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  Ability to travel up to 10%

PREFERRED QUALIFICATIONS:

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  Minimum of 6 years previous experience with program and project management; global experience strongly preferred.

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  Ability to build and maintain positive relationships with management and peers.

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  Ability to work independently and manage multiple tasks in a fast-paced environment.

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  Ability to work effectively on cross-functional teams.

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  Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.

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  Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.