Clinical Operation Manager
About iTakeControl, a Red Nucleus company
iTakeControl is a mHealth and mClinical real world evidence and mobile application for the biopharma and life science organizations. We offer a comprehensive suite of real world evidence services and tools: real world evidence planning, mobile clinical trial data, mobile learning and training for biopharma compliance, and open science, real world mobile health apps for patients. The company is formed out of Shire and Genzyme leadership experience, with over two decades in genetic disease, rare diseases, and patient-centric education. Red Nucleus acquired iTakeControl in March 2021. Red Nucleus is the premier provider of learning, performance, and process solutions for the life sciences industry. iTakeControl is part of the Clinical group within Red Nucleus. We are based in Philadelphia, PA and Boston MA.
The Clinical Operation Manager is responsible for working with the Product Management and Client Services Delivery teams to operationalize clinical research studies. The role is responsible for detailed specification development, documentation, and supporting project management and delivery activities for the iTakeControl customer projects.
- Ability to understand real world protocols, data collection processes, and GxP processes.
- Ability to provide clinical operations support including project, sponsor, site and vendor management.
- Participate in protocol design discussions.
- Provides expertise on clinical operations during study start-up and manages study and sponsor relationship upon deployment.
- Ability to understand study requirements, EDC and or EHR systems, user needs, and logical business requirements.
- Ability to understand ePRO systems for patient-centric research, data collection, and patient engagement.
- Ability to develop and manage required documentation including IRB submissions packages, training content, caregiver/site manuals.
- Collaborate with Data Manager to develop documentation including Data Management Plan and EDC supporting documentation such as CRF Specifications, eCRFs.
- Manages and leads Site Initiation Visits (SIV) and site/central rater training as needed.
- Smart, talented and creative. Passionate about innovation and work to high standards.
- Well organized, obsessed with details, and capable of juggling multiple projects.
- Collaborative in a team environment but also confident learning and working independently.
- Ability to manage project schedules and effectively report and communicate progress.
- Work closely with customers and other-cross functional team members, from biotech clients to technical developers.
- Willing and eager to learn technology and design for UI/UX on iOS and Android applications.
- Assist with quality control testing to requirements.
- Ability to manage UAT and product launch requirements.
- Minimum of undergraduate degree with 3 years professional biopharma industry, consulting, digital, or mobile app experience, or 1 year post graduate experience.
- Completed undergraduate degree, Master’s degree a plus.
- Must be proficient in Microsoft Office, with experience in research systems, such EDC, ePRO, or EHR systems.
- Comfortable learning new technologies, applications, and systems.
- Must be able to provide a relevant portfolio/history of projects, studies, or applications.
Must be 18 years or older.
Must have an undergraduate degree from an accredited University.
Must be US based.
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Company Website: www.itakecontrolhealth.com
Application Email: email@example.com