The Minneapolis Heart Institute Foundation® (MHIF) is seeking a Clinical Research Manager to join its outstanding research team and lead the vibrant and expanding structural heart research specialty area. Now in its 37th year, MHIF is one of the leading cardiovascular research and education institutions in the country. We exist to create a world without heart disease and our mission is to improve people’s lives through the highest quality cardiovascular research and education.
In support of the Minneapolis Heart Institute Foundation (MHIF) mission, the Clinical Research Manager (Manager) provides managerial and leadership oversight for day-to-day clinical research operations for a 6 -8-person clinical team within MHIF Research Operations. The Manager supervises and ensures effective optimization and engagement of the Research Associates, Associate Research Coordinators and Clinical Research Coordinators (CRC’s) on their team. The Manager works closely with the other clinical research managers as well as with the Director, Center for Valvular and Structural Heart Disease in the advancement of the Valve Science Center and its strategy.
1. Strategy and Goals/Clear Direction
• In line with the overall strategy and goals of MHIF, the Manager develops goals and objectives for the unit and cascades to goals for team members, providing clear alignment and contribution to the greater department goals.
• Regularly communicates key information to staff and proactively communicates department information to key stakeholders, including physicians.
2. Operational Effectiveness and Execution
• Allocates work, delegates work assignments, and matches skills to the work to ensure that work is assigned at the right level to optimize staff talents and effectiveness.
• Plans, establishes metrics, oversees and evaluates the execution and productivity of the ongoing operations of the research unit through the quarterly business reviews.
• Oversees and evaluates the groups productivity and work quality.
• Develops and oversees processes and procedures to enhance operational efficiency. Champions lean exercises. Holds team accountable for meeting and/or exceeding SOP requirements.
• Builds systems and a culture of accountability; creates a culture of learning from success and failure.
• Monitors team quality standards and programs in alignment with organizational quality programs, standards and grant and/or contract parameters.
• May coordinate data compilation and computation, ensuring quality control and compliance with protocol; reviews results for validity and reliability, and provides initial analyses of results.
• Monitors unit’s performance to budget.
3. Collaboration, Change and Culture
• Ensures collaboration with and leverages other research managers and shared services teams, programs and functions. Proactively communicates to ensure alignment and synchrony.
• Identifies problems, barriers and successes; removes roadblocks and rewards success in the team.
• Builds and maintains a supportive team environment and cross-functional team relationships.
• Helps the team through change. Builds a positive team culture and role models and reinforces behaviors that support MHIF values and culture.
4. Budget and Study Portfolio Management
• Supports study budget contracting and resource allocation.
• Understands complexity and anticipates budget/contract process for first-in-man or novel therapies.
• Reports on project time allocation and reconciling actual to plan.
• Reports revenue/expenses for responsible projects and implements strategies that improve the overall profitability of the group.
• Makes recommendations regarding study selection.
• Prepares for and helps lead section meetings with physicians, providing key information, enrollment status and always forging the partnership.
5. Staffing and Team Member Development
• Evaluates resource needs for the entire Operations team.
• Interviews candidates for key hires and leads selection of final hire.
• Identifies growth needs, provides reinforcing and constructive performance feedback, and provides coaching in the areas of skill, knowledge, performance and behaviors for direct reports.
• Creates development opportunities for employees and leads development conversations.
• Cultivates an environment and culture which reinforces MHIF values that engages and retains employees.
• Develops solutions that maintain and/or improve morale and overall staff engagement.
• Bachelor’s degree in biologic/medical sciences or equivalent experience.
• A minimum of 3 years of experience leading clinical research projects including projects evaluating drugs or devices that are not FDA approved. Must have a track record initiating, executing and completing clinical research projects.
• A minimum of 2 years of supervisory/manager experience leading highly skilled clinical/medical personnel which may include hiring, training, coaching, developing and managing performance of individuals or equivalent and proven experience in influencing, support, and coaching others.
• Clinical Research Coordinator/Professional (CCRC or CCRP) certification.
• Good command of clinical trial acumen and sound clinical judgement.
• Experience leading teams with a track record of coordinating work with team members.
• Versatile and effective interpersonal skills with a wide range of employees and stakeholders.
• History of exhibiting personal leadership - has worked well during periods of change, has contributed positively to communications, and collaborated effectively across the organization.
• Evidence of being self-aware with emotional maturity, self-management and poise under pressure.
• Experience in managing and assessing workflow and assigning and evaluating resources.
• Professional degree in medical sciences (RN, RD, MPH, etc).
• Greater than 5 year’s manager experience within a clinical/medical organization which included responsibilities for budgets, goals, strategies, process improvement, etc.
• Expertise and working knowledge of cardiovascular diseases and therapies.
• High learning agility, goal-oriented, self-directed in work and learning and development.