At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
The Senior Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements. This position works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. The Senior Clinical Research Monitor may play a leadership role in managing monitoring activities.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 80% of travel to enhance collaboration and ensure successful completion of projects.
Responsibilities may include the following and other duties may be assigned.
Monitors progress of clinical trials at the site level and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
Responsible for reviewing medical records with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
May assist with design, development, and monitoring of clinical evaluation projects.
Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance
May contact and recommend qualified investigators to perform studies and initiate clinical trials.
Ensures recruitment and retention of patients.
Mentor and/or train junior personnel
Assist site/study teams with audit preparation
Author Monitoring Plans and other study materials
Ensures monitors are trained, current with project requirements and understand study milestones
Must Have:
Bachelor’s degree plus a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
Nice to Have:
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
Practical knowledge of project management
Clinical experience
Knowledge of/experience with CTMS/EDC/eTMF/Veeva Vault
Experience with Good Clinical Practice (GCP)
Excellent interpersonal skills
Experience working in a team/matrix environment requiring strong working relationships
Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
Ability to work in a fast-paced environment
Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
High attention to detail and accuracy
Experience working independently in a regional area with remote or minimal supervision
Strong leadership skills
Excellent problem-solving skills
Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
Business knowledge or experience with the medical / healthcare industry
Class III medical device and/or phase II, III and IV pharmaceutical experience
Experience to demonstrate understanding of technical, scientific and medical information
Experience with Regulatory and Quality Assurance audits
Experience of conducting clinical research activities in a regulated environment
Proficient knowledge of medical terminology
Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)
Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)
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.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.