Summary of Major Responsibilities
This position will be part of the Clinical Affairs Team, which is responsible for planning, executing, managing and closing projects associated with the company clinical study plans. The Senior Clinical Study Manager (Sr. CSM) is a proven leader in clinical program management in the device industry, and manages, executes and reports on clinical study operations. The Sr. CSM provides leadership and support to members of the multidisciplinary project team, internally and externally.
This position can be located in Madison, WI or remote with travel back to the home office.
Essential Duties and Responsibilities
- Act as a customer advocate throughout the project lifecycle.
- Understand and support global project goals including site recruitment, patient recruitment, marketing and PR, as appropriate.
- Leads the development of study specific protocols, consent forms, and other trial related materials (e.g., Study Monitoring Plan, Patient Guide, Project Plan, etc.) as required
- Ensure the appropriate development of all documents by CROs including but not limited to: study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.
- Develop, manage, and track clinical trial budgets to include review and approval of all vendor and site payments. The Sr. CSM is also responsible for notifying management of anticipated change orders and/or budget adjustments.
- Implement approved clinical study protocols and operational plans, which are consistent with strategic corporate and R&D objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies.
- Coordinate with applicable cross-functional teams (e.g., R & D, Operations, Exact Sciences Laboratories) to identify goals and scope of clinical study projects. Manage and execute the overall project scope, budget, and timelines.
- Initiate and train sites to the study protocol. Ensure proper site adherence to clinical research regulations.
- Manage resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, central IRBs, and contractual agreements.
- Support the management and oversight of CROs and other clinical study related vendors as applicable.
- Plans for and manage all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational device.
- Ensure maintenance of project files according to applicable regulations, guidelines, and corporate policy (e.g. GCPs and company SOPs).
- Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.
- Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities, as required.
- Ensure operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed.
- Develop and maintain detailed timelines and resource projections for all programs.
- Work with Director of Clinical Affairs to help ensure that internal project team members are trained appropriately to ensure proper study conduct.
- Prepare and distribute appropriate communications required to properly manage and document activities on the studies.
- Facilitate the completion of database development, statistical analysis and clinical study report writing.
- Manage relationships with consultants to provide adequate support and services for data collection and analysis.
- Serve as a resource and mentor for other Clinical Affairs personnel
- Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.
- Attend off site-meetings and conferences, as needed.
- Experience qualifying & managing external vendors (e.g. CRO, Call Center, Central labs, etc.)
- Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies.
- Experience writing, reviewing and editing protocols and clinical study reports.
- Demonstrates knowledge of Good Clinical Practices and all applicable US regulations governing clinical research, as well as working knowledge of the FDA submission process including IDE, PMA, and 510(k).
- Demonstrates problem-solving and interpersonal skills.
- Must have a ‘can-do’ attitude and a strong desire to take ownership of many different projects.
- Excellent organization and communication skills, including experience dealing with decision makers, such as physicians, IRB members, and FDA staff.
- Strong desire to join a small company and work in a fast-paced environment.
- Ability to work independently and manage multiple timelines, while maintaining the team focus.
Education and Experience
- Bachelor’s degree.
- Minimum seven years’ experience in clinical research, with at least 3 years of clinical project/study management, and 2 years of device experience.
- Experience managing clinical project team personnel.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to sit and/or stand for an extended period of time.
- Ability and willingness to travel (by land and air), both domestically and internationally, on occasion.
- Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
- Ability to exercise judgment and determine appropriate action for a wide range of issues of varying complexity.
- Ability to manage multiple deadlines.
- Ability to lift and move up to 40 pounds on an occasional basis.