Senior Clinical Research Manager- Pelvic Health at Medtronic
Minneapolis, MN 55432
About the Job
We anticipate the application window for this opening will close on - 17 Jan 2025At 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.A Day in the LifeIn this exciting role as a Senior Manager for Clinical Research (Sr CRM) in the Neuromodulation Operating Unit, you will have primary responsibility to oversee the management, execution and daily activities of the Medtronic sponsored Pelvic Health clinical studies.
This is a managerial role reporting to the Director of Clinical Research for Pelvic Health.
The Sr CRM will independently handle various clinical study assignments, have management responsibility, help support the overall clinical strategy for the business and oversee and direct the work of a team of Clinical Research Specialists.
Our vision is to become a world leader in Neuromodulation, improving patient lives through innovative solutions.
Our therapies span the care continuum from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.
We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes.
We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.
To learn more about Inclusion & Diversity at Medtronic Click HereLocation: Rice Creek, MN preferred / open for remote location.Travel up to 10%Responsibilities may include the following and other duties may be assigned.Provides leadership for the conduct of clinical studies and in the development of clinical evidence for pre-market and post-market trials/studies as it applies to product lifecycle.Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely manner.Collaborates and implements clinical/regulatory strategies to obtain timely product approvals from relevant regulatory bodies as well as fulfilling reimbursement needs and additional marketing claims needed for therapy adoption.Builds and maintains a strong network and close relationship with the various internal and external stakeholders, including key opinion leaders.Provides oversight of study team performance, with accountability for milestones and budget managementLeads talent development, hiring, coaching, mentoring and performance of direct reportsActively identifies and leads functional process improvementQualifications - Must Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume.Bachelor’s degree required and a minimum of 7 years of experience in managing clinical research studies with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience in managing clinical research studies with 5+ years of managerial experience*Managerial/leadership experience (i.e., experience as a manager having direct or indirect reports, people leader).Nice to Have (Preferred Qualifications):Advanced degree (Masters, PhD or MD) preferred.
Technical degree defined as engineering, life sciences or related medical/scientific field. 7+ years’ experience managing multiple clinical research studies at Medtronic or in medical device industry.Experience managing direct reports and leading clinical teams. Cost-center/budget & resource planning & management experience.Experience in medical device clinical product trials and regulations.Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial.Experience managing clinical trial operations from start to finish.Global clinical trial strategy and execution, and outcomes research study design.Proficient knowledge of clinical research study processes and study design.Track record and experience in hiring and developing talent.Competencies:Leadership skills include strong communication, sense of urgency, high accountability, problem solving, quality focus, business integration acumen, and change management. Demonstrated ability to work effectively globally on cross-functional teams.Experience in a high-demand and fast-paced environment. Physical Job RequirementsThe 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.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.Salary ranges for U.S (excl.
PR) locations (USD):$156,800- $235,200The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.
The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.
Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).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 plansAbout MedtronicWe 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 90,000+ 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.SummaryLocation: Fridley, Minnesota, United States of AmericaType: Full time
You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeIn this exciting role as a Senior Manager for Clinical Research (Sr CRM) in the Neuromodulation Operating Unit, you will have primary responsibility to oversee the management, execution and daily activities of the Medtronic sponsored Pelvic Health clinical studies.
This is a managerial role reporting to the Director of Clinical Research for Pelvic Health.
The Sr CRM will independently handle various clinical study assignments, have management responsibility, help support the overall clinical strategy for the business and oversee and direct the work of a team of Clinical Research Specialists.
Our vision is to become a world leader in Neuromodulation, improving patient lives through innovative solutions.
Our therapies span the care continuum from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.
We're committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes.
We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.
To learn more about Inclusion & Diversity at Medtronic Click HereLocation: Rice Creek, MN preferred / open for remote location.Travel up to 10%Responsibilities may include the following and other duties may be assigned.Provides leadership for the conduct of clinical studies and in the development of clinical evidence for pre-market and post-market trials/studies as it applies to product lifecycle.Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines.The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely manner.Collaborates and implements clinical/regulatory strategies to obtain timely product approvals from relevant regulatory bodies as well as fulfilling reimbursement needs and additional marketing claims needed for therapy adoption.Builds and maintains a strong network and close relationship with the various internal and external stakeholders, including key opinion leaders.Provides oversight of study team performance, with accountability for milestones and budget managementLeads talent development, hiring, coaching, mentoring and performance of direct reportsActively identifies and leads functional process improvementQualifications - Must Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume.Bachelor’s degree required and a minimum of 7 years of experience in managing clinical research studies with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of experience in managing clinical research studies with 5+ years of managerial experience*Managerial/leadership experience (i.e., experience as a manager having direct or indirect reports, people leader).Nice to Have (Preferred Qualifications):Advanced degree (Masters, PhD or MD) preferred.
Technical degree defined as engineering, life sciences or related medical/scientific field. 7+ years’ experience managing multiple clinical research studies at Medtronic or in medical device industry.Experience managing direct reports and leading clinical teams. Cost-center/budget & resource planning & management experience.Experience in medical device clinical product trials and regulations.Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trial.Experience managing clinical trial operations from start to finish.Global clinical trial strategy and execution, and outcomes research study design.Proficient knowledge of clinical research study processes and study design.Track record and experience in hiring and developing talent.Competencies:Leadership skills include strong communication, sense of urgency, high accountability, problem solving, quality focus, business integration acumen, and change management. Demonstrated ability to work effectively globally on cross-functional teams.Experience in a high-demand and fast-paced environment. Physical Job RequirementsThe 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.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.Salary ranges for U.S (excl.
PR) locations (USD):$156,800- $235,200The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.
The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.
Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).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 plansAbout MedtronicWe 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 90,000+ 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.SummaryLocation: Fridley, Minnesota, United States of AmericaType: Full time