Key Responsibilities:
• Manage and/or lead a small team within the assigned function including team budget responsibilities and managing outside contractors/vendors. Oversee the conduct of the internal clinical operations team including management of performance metrics, effectiveness, LMS compliance, CTMS completeness and TMF quality. Develop team members to increase business acumen and functional skills. Collect performance feedback of assigned staff from cross-functional stakeholders. Provide strategic direction of the internal clinical research team. Assign and prioritize work-related assignments to direct reports.
• Facilitate the creation of process training materials for the internal clinical research team. Conduct training for internal clinical operations staff. Lead in the development of work instructions, forms, templates and operational processes. Coordinate and present at department team meetings. Manage the on-boarding and off-boarding of assigned staff.
• Identify, evaluate and implement clinical process improvement opportunities. Lead change management processes to ensure successful rollout.
• Provide direction and guidance on clinical operations (e.g., informed consent review). In collaboration with the project managers, ensure team effectively executes project deliverables. Represent the functional team at Core Team meetings.
• Other incidental duties
Required Experience:
•Bachelor’s Degree in science or health related field
•Clinical Research Experience
•Study Management Operations experience
Preferred Experience:
•Clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas
•People Management
•Training and onboarding experience
Additional Expectations:
• Proven successful project management leadership skills with ability to meet deadlines on multiple projects
• Proficient in Microsoft Office Suite and related tools and systems (e.g., CTMS)
• Proficient facilitation and presentation skills
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Ability to work positively through confrontation and/or conflicting ideas
• Extensive understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR)
• Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Knowledge of financial mechanism that relates to study management operations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of study management to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Primarily interacts with internal subordinates and other supervisors
• Typically interacts with external suppliers, vendors and/or customers
• Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Travel Requirements:
5-10%
