Clinical Study Manager
Location: BelgiumWith minimal oversight, exercises judgment and latitude in determining objectives and approaches to assignments, manages clinical studies and related trials for medical devices. Responsible for managing the study within pre-agreed upon timelines, budget, SJM processes and applicable regulations with minimal oversight. Represents the clinical department throughout the organization, particularly as the Clinical Department’s representative on the Program Management team. Exercises judgment in planning and organizing work; monitors performance and reports status.
TASKS & RESPONSIBILITIES :
• Manages multiple, smaller IDE and post market studies (within the same therapeutic area).
• Has broader knowledge of US and international regulations and standards.
• Leads Clinical Project Team Meetings. May Serve as Core Team Clinical Representative.
• Manage CT.gov postings.
• Key contributor to the development of the CIP, training plan/requirements, and other study related documents. Understands and complies with WI and SOPs.
• Achieve project quality by ensuring site adherence to the study protocol. Responds to audit reports and follows through on audit finding resolutions.
• Begins to engage with key opinion leaders and SJM Sr. Leadership with guidance
• Serves as a junior mentor to CRAs.
• Sets expectations for CRA/provide feedback to RA management.
• Has limited participation in Special Projects (WI Teams, etc.)
• Contributes to the development of publication strategies, executes the publication strategy.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Bachelor’s degree required (Biology/Science preferred)
• Five to eight years clinical research experience
• Three to five years study management experience preferred
• Experience working in a broader enterprise/cross-divisional business model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.
We offer a market competitive compensation package and a truly international working environment.
TASKS & RESPONSIBILITIES :
• Manages multiple, smaller IDE and post market studies (within the same therapeutic area).
• Has broader knowledge of US and international regulations and standards.
• Leads Clinical Project Team Meetings. May Serve as Core Team Clinical Representative.
• Manage CT.gov postings.
• Key contributor to the development of the CIP, training plan/requirements, and other study related documents. Understands and complies with WI and SOPs.
• Achieve project quality by ensuring site adherence to the study protocol. Responds to audit reports and follows through on audit finding resolutions.
• Begins to engage with key opinion leaders and SJM Sr. Leadership with guidance
• Serves as a junior mentor to CRAs.
• Sets expectations for CRA/provide feedback to RA management.
• Has limited participation in Special Projects (WI Teams, etc.)
• Contributes to the development of publication strategies, executes the publication strategy.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Bachelor’s degree required (Biology/Science preferred)
• Five to eight years clinical research experience
• Three to five years study management experience preferred
• Experience working in a broader enterprise/cross-divisional business model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.
We offer a market competitive compensation package and a truly international working environment.
