Clinical Program Manager at Inogen in Goleta, California

Job Description:

Job Summary:

The Clinical Program Manager will lead all clinical study activity for the Company’s respiratory therapy products. This position will manage assigned and allocated internal/external resources to deliver clinical studies aligned with the Company’s strategy, scope, timeline budget, and ensure collaboration with Company on the priorities, risk, changes, critical milestones and budget/resource needs. The Clinical Program Manager will research, design, administer, and implement Company clinical studies, including existing literature research, CRO selection, investigator selection, analysis of potential patient recruitment, and preparation of study related documentation, while following Company standard operating procedures aligned to company strategy and product roadmap.

This position will create and manage a clinical based Key Opinion Leader (KOL) program aimed at guiding the Company’s clinical study, product roadmap, product performance, and marketing deliverables.  The Clinical Program Manager will utilize the KOL network, comprehensive existing evidence literature research, and other tools in addition to their experience and expertise to help guide the Company’s upstream marketing efforts. By delivering value from clinical study management, clinical voice of customer, product roadmap/specification contributions and others, the position will work closely with other commercial team partners to ensure the Company’s objectives are met.

Responsibilities (Specific tasks, duties, essential functions of the job)

• Assist in defining and shaping Inogen’s clinical study strategy for existing and new products, aligned to company strategy and product roadmap. 


• Oversee clinical studies, working closely with Product Management to validate clinical application and use for applicable markets.


• Create Clinical Study design, outlining the purpose and methodology of the trial, presents study protocols to a steering committee for execution.


• Creates clinical study materials and associated written documentation, including patient consent documents, letters of agreement, confidentiality agreements, study protocols, case report forms, and investigators brochures.


• Identifies study sites and facilitates approval and site initiation through medical review boards (IRB).


• Coordinates, manages and implements study process.


• Manage patient recruitment strategies to increase patient randomization into the study.


• Manage data collection process, designs forms; collects data from hospitals, general practices, and other research sites; and verifies that data entered onto the forms are consistent with patient clinical notes/source data/document verification and are immediately entered into the database.


• Manage data analysis with a medical biostatistician for study design, subject number determination and post study data analysis.


• Acts as a liaison between Inogen and medical staff/patients conducting clinical studies.


• Negotiates with 3rd parties (vendors, consultants and other companies for joint studies) to design and initiate clinical studies, provide technical direction in contract research organization (CRO) and vendor selection/management, budget planning and overall study management.


• Establish a KOL network consisting of Pulmonologists and others in the field of respiratory care.  Utilize the network to obtain guidance on a range of topics from clinical studies, product roadmap, product design inputs, marketing programs, etc.


• Represent the Company at key clinical conferences to showcase clinical programs and/or results


• Facilitate preparation final study reports and manuscripts for publication.


• Monitors and summarizes scientific literature for impact to existing / future study activity.


• Maintain regular and punctual attendance.


• Comply with all company policies and procedures.


• Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

• Knowledge and understanding of clinical reporting, including manual and electronic data capture.


• Excellent interpersonal communication skills, fluency in additional languages is a plus.


• Excellent team member with a strong willingness and ability to work cross functionally across projects at different stages of development in a fast-paced, entrepreneurial environment


• Ability to manage conflict, drive consensus, and promote decision-making


• Ability to independently identify and manage project objectives, work plans, timelines, budgets, providing formal and informal status updates to stakeholders as needed


• Ability to challenge assumptions


• Anticipates business and industry issues; recommends relevant process / technical / service improvements


• Demonstrates broad expertise or unique knowledge


• Considered an expert within the company and may have external presence in area of expertise


• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team


• Ability to work as part of and lead multiple teams


• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.


• Excellent computer skills


• Excellent communications, problem-solving, analytical thinking skills.


• Sees broader picture and longer-term impact on division/company.


• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.


• Excellent project management, strong project leadership skills.


• Ability to effectively interact with individuals at all levels across the organization


• Must have strong work ethic.


• Excellent oral and written communication skills required.


• Attention to detail is required.


• Effective conflict resolution.


• Analytical & problem-solving skills & ability to multi task.


• Solutions-oriented problem solver.


• Excellent planning, communication and organizational skills.


• Ability to effectively interface with different departments within the company.

Qualifications (Experience and Education)

• Bachelor’s Degree, or equivalent, in Biological, Medical, or Statistical Sciences, required


• 7 years’ experience in clinical research, required; preferably in the medical device industry as the subject matter expert for respiratory therapy clinical areas.


• Intermediate knowledge of regulatory aspects concerning human subject research (e.g. ICH-E6: GCP and ISO 14155, as well as MDD and MDR), preferred.


• PMP or PMI-ACP Certification, preferred.


• Advanced knowledge/proficiency of Clinical development process and inter-dependencies of key functions, required.


• Advanced knowledge/proficiency in Microsoft Office, required.


• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.