Manager, Clinical Site Management
OM1, United States
Job Description
OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics to transform records from a diverse set of sources into enriched, research grade data which allows us to generate unique insights in a variety of disease areas.
With limited oversight, the Manager of Clinical Site Management role is to implement agreed upon strategies for the management site activities for Next Generation Registries with pre-specified timelines and budgets at the project level. These project are typically large, complex, full service studies. The Manager, CSM leads the CSM team and is responsible for the successful conduct and completion of site management activities to the contracted budget and timelines while ensuring the quality of the project according to ICH/GCP (as applicable), OM1 and/or Client SOPs, guidelines and requirements. They will serve as the point of contact for internal/external customers and act as the liaison to the Client for study related issues.
- Manage the progress of assigned studies by documenting regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution
- Collect, review and approve of all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and audit ready throughout the course of the study.
- Work closely with PI/ Sponsor assist with management of vendor activities
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to senior leadership on the Client Services team.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Develop/contribute to clinical documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials and other study tools.
- Work closely with Data Management, Systems and Biostatisticians to assist with the design of case report forms, study portals and electronic data capture systems.
- Support strategic opportunities to enhance and improve the project (e.g., site retention activities)
- Mentor and/or manage site management staff and other team members as applicable.
- Ability to Travel
Requirements
- Excellent time management and organizational skills, able to produce high quality work independently or as part of a team, be able to multitask and work in a high volume, deadline-controlled environment.
- The ability to learn quickly, multi-task and prioritize are essential
- Problem solving skills; very strong written, verbal communication skills
- 5 or more years of Project Management experience in the health care, medical research, CRO or healthcare technology setting
- Bachelor’s degree and/or equivalent experience
- Knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and understanding of the clinical development process (Phase I-IV, post marketing, abstraction protocols and/or REMS)
OM1 is an equal employment opportunity employer and considers qualified applicants without regard to gender, sexual orientation, gender identity, religion, race, veteran or disability status. At OM1 ensuring that people feel respected, valued, and included is essential to our success. We are committed to working together to provide a work environment that embraces the principles of diversity, equity, and inclusion.