This is a question we’ve asked ourselves over and over. It’s how we at Medtronic have made hearts beat stronger and longer. It’s how we’ve pushed the limits of what technology can do in and for the body. It’s how we will continue to alleviate pain, restore health and extend life. Rising costs, an aging population, and the burden of chronic disease impact us all. And no single entity in the healthcare system can solve these challenges alone. That’s why we’re stepping forward. That’s why we’re prepared to put the full power of our technologies, services, resources — and our people — to work with new partners, in new ways, to usher in a new era in healthcare.
Post : Clinical Research Manager - TMVR
Job Description
• Manage clinical study personnel focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies. Interprets and executes on policies and procedures appropriate to clinical programs under his/her management. Recommends modifications to policies and procedures to larger clinical organization as necessary.
• Accomplishes results through experienced clinical research employees who exercise significant latitude and independence in their assignments.
• Provides ongoing training, direction and guidance on all clinical programs under their supervision.
• Conduct quarterly performance reviews and continuous employee development.
• Provide leadership and program representation with internal partners and external customers.
• Supervise training of study personnel including internal staff and external study sites (e.g. Principal Investigators, Study Site Support Staff, etc.)
• Functions as an advisor to the Clinical Department Leadership regarding study strategy, projects, individual tasks and overall study operations.
• Ensures projects/programs are completed on schedule and within budget. Will drive highest quality program execution. Continually assess best practices and implement continuous improvement across studies as well as provide input to global department program execution.
• Participate on key functional workgroups to drive clinical wide or cross-departmental initiatives.
• Provide significant input and oversight to clinical program budgets.
• Ensures appropriate resources are maintained to effectively conduct clinical programs.
• Gives direction to staff on program priorities for various projects assigned to their area.
• Proactively engages senior clinical management in program risk discussions and provides well thought out solutions to issues.
• Identifies opportunities to strengthen clinical program quality and efficiency by assessing resource needs and capacities to ensure business objectives are met.
Candidate Profile
• Bachelor’s Degree
• 8+ years’ experience managing clinical research studies. (Master’s degree will substitute for 1 year experience; Ph.D. will substitute for 2 years’ experience).
• Experience managing clinical trials from start to finish.
• Experience managing global clinical trials; industry sponsored
• Experience providing work direction to staff and accomplishing study execution through others.
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Nice to Have
• Bachelor’s Degree in engineering, life sciences or related medical/scientific field.
• Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, social science, engineering, or other related medical/scientific field).
• Previous personnel management
• Experience managing cardiovascular medical device and/or pharmaceutical trials.
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003, Good Clinical Practice(GCP)
• Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals
• Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness.
• Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers
• Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances
• Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers
• Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills
• Willingness to accept challenging assignments and engage in relevant developmental activities
• Proficient knowledge of medical terminology
• Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
• Demonstrated ability to clearly and effectively communicate verbally and in writing
• High attention to detail and accuracy
• Exceptional project management capabilities and proficient use of project management tools
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Additional Information:
Experience : 1+ years
Qualification: Bachelor’s Degree
Location: Mounds View, Minnesota, United States
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: CR
End Date: 30th April, 2018
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