Senior Manager, Clinical Monitoring (Remote - US) - United Therapeutics
Raleigh, NC
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
Manage and allocate assigned Clinical Monitoring staff (CRAs, iCRAs, MTLs) to ensure projects are appropriately resourced and employees are trained and meeting corporate and project objectives, timelines, deliverables and milestones. Lead, coach, and motivate Clinical Monitoring staff to ensure adherence to department standards and facilitate training and oversight of department procedures. Mentor and support junior Managers and Clinical Monitoring staff concerning career development and performance improvement. Take ownership or collaborate on organizational improvement within Clinical Monitoring and the larger Clinical Operations organization of UTC. This position is based remotely anywhere in the continental United States and has a travel expectation of up to 50%.
Department Duties/Responsibilities:
+ Regularly interact with senior management or executive levels regarding Clinical Monitoring functional area activities; influence senior level leaders regarding matters of significance to United Therapeutics Corporation
+ Propose, develop and implement plans, policies, guidelines, forms/templates and Standard Operating Procedures (SOPs) for Clinical Monitoring to Associate Director/Director
+ Assist Associate Director/Director, Clinical Monitoring and Training Department to develop and administer an effective orientation/on-boarding process for new hire Clinical Monitoring staff
+ Collaborate with Clinical Monitoring Management and/or cross functional departments in relevant process improvement initiatives; may assist with the creation and delivery of new Clinical Monitoring Department initiatives; improvement plans or training
+ Lead Clinical Monitoring team with resolution of findings from Clinical Quality Assurance audits and/or regulatory inspections
+ Develop and maintain effective relationships with Clinical Operations Management team
+ Collaborate with Clinical Monitoring Management members to ensure consistent oversight of Clinical Monitoring staff
+ Coordinate and facilitate Clinical Monitoring Department Meetings; including the development/distribution of agendas and minutes, as required
+ Serve as a mentor to Clinical Monitoring Managers/Associate Managers, and staff to develop best practices and ensure efficient/effective monitoring activities are applied across studies
+ Serve as a Subject Matter Expert (SME) for systems/technology, development of new templates for Clinical Monitoring Department
+ Assist Associate Director/Director, Clinical Monitoring with administration and forecast of functional area budget, timelines, and performance, assist with budget planning
Personnel Management Responsibilities:
+ Ensure productivity, quality, and consistency of direct reports performance through routine review of available metrics and communication with direct reports; assist with resolution of performance issues/discussions escalated from junior Managers and ensure issues/performance discussions are escalated appropriately to the Associate Director/Director, Clinical Monitoring
+ Complete and deliver performance assessments of direct reports
+ Conduct routine one-on-one meetings with direct reports to discuss workload, performance, and provide feedback/recommendations
+ Provide guidance and coaching to direct reports to increase competencies and career development growth
+ Mentor junior managers on personnel management, as needed
+ Manage leave requests and review/approve business expenses, as required
+ Conduct assessments (onsite visit activities, in-house monitoring activities and monitoring lead function activities) of Clinical Monitoring staff
Corporate, Therapeutic, and Industry Training Responsibilities:
+ Attend relevant conferences, scientific meetings and corporate offered training sessions, as required/necessary, to remain current on therapeutic areas under study for UTC products and industry practices
+ Identify/communicate lessons learned and implement best practices to promote ongoing improvement within Clinical Monitoring/Clinical Operations
Project Duties/Responsibilities:
+ Represent Clinical Monitoring and interact with strategic partners on study teams for outsourced clinical studies
+ Provide leadership and guidance on interactions with UTC Medical Science Liaisons (MSLs) to optimize relationship with investigational sites
+ Serve as a point of escalation for Clinical Monitoring and/or staff performance issues for clinical studies
+ Provide input into the feasibility and risk assessment (initial/ongoing) of clinical protocols
+ Participate in networking activities with important institutions and investigators
+ Build and maintain long-term professional relationships with clinical investigators
+ Attend, contribute and/or present at Investigator Meetings, as necessary
+ Conduct field/central monitoring and/or Monitoring Team Lead activities (e.g. on-site visits, central data review, analytics review, site management, or monitor visit documentation review) to support monitoring activities, as necessary
+ Support the Monitoring Team Lead (MTL) or designee in the development of the monitoring/site and subject recruitment strategies; review Clinical Monitoring Plan (CMP), as necessary
+ Perform other duties as required
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in biological sciences, nursing or related field
+ 10+ years of experience as a Clinical Research Associate (CRA)/CRA Manager along with prior relevant experience in pharmaceutical/biotech/medical device or CRO industry with progressive experience working in clinical trials and
+ 4+ years of relevant monitoring team/trial management experience and
+ 4+ years of experience with resource/people management, conflict/resolution management, change management, and people motivation skills
+ Demonstrated ability to effectively provide guidance and direction to others and demonstrate experience in clinical trial management, monitoring and developing study documentation (e.g. operational plans, report/letter templates and annotations, and training materials for the monitoring team)
+ Knowledge of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH) Guidelines, and Good Clinical Practices (GCP)
+ Competent end user of UTC electronic systems (Phlex eTMF, Medrio/Oracle InForm/Medidata RAVE EDC, Clario CTMS)
+ Understanding of the clinical research process; including working knowledge of clinical monitoring duties/responsibilities
+ Ability to mentor and/or coach clinical staff; problem-solving abilities to assist others to resolve/recommend solutions to clinical monitoring issues
+ Demonstrated leadership to support change management within the Clinical Monitoring function and/or collaborating with cross functional leaders for department changes
+ Effective knowledge of resource management of Clinical Monitoring staff
+ Demonstrated experience with CAPA Management
+ Good written/oral communication skills; including ability to provide training and present topics/study or department materials to an audience
+ Demonstrated leadership and good interpersonal abilities to establish and maintain effective working relationships with direct reports, coworkers, vendors, and senior management
+ Competent end user of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, TEAMs)
Preferred Qualifications
+ 1+ year of previous experience with all phases of clinical research
+ Knowledge of relevant medical/therapeutic areas for UTC and understanding medical terminology
+ Effective time management and organizational skills to manage competing priorities
The salary for this position ranges from $150,000 to $187,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
Manage and allocate assigned Clinical Monitoring staff (CRAs, iCRAs, MTLs) to ensure projects are appropriately resourced and employees are trained and meeting corporate and project objectives, timelines, deliverables and milestones. Lead, coach, and motivate Clinical Monitoring staff to ensure adherence to department standards and facilitate training and oversight of department procedures. Mentor and support junior Managers and Clinical Monitoring staff concerning career development and performance improvement. Take ownership or collaborate on organizational improvement within Clinical Monitoring and the larger Clinical Operations organization of UTC. This position is based remotely anywhere in the continental United States and has a travel expectation of up to 50%.
Department Duties/Responsibilities:
+ Regularly interact with senior management or executive levels regarding Clinical Monitoring functional area activities; influence senior level leaders regarding matters of significance to United Therapeutics Corporation
+ Propose, develop and implement plans, policies, guidelines, forms/templates and Standard Operating Procedures (SOPs) for Clinical Monitoring to Associate Director/Director
+ Assist Associate Director/Director, Clinical Monitoring and Training Department to develop and administer an effective orientation/on-boarding process for new hire Clinical Monitoring staff
+ Collaborate with Clinical Monitoring Management and/or cross functional departments in relevant process improvement initiatives; may assist with the creation and delivery of new Clinical Monitoring Department initiatives; improvement plans or training
+ Lead Clinical Monitoring team with resolution of findings from Clinical Quality Assurance audits and/or regulatory inspections
+ Develop and maintain effective relationships with Clinical Operations Management team
+ Collaborate with Clinical Monitoring Management members to ensure consistent oversight of Clinical Monitoring staff
+ Coordinate and facilitate Clinical Monitoring Department Meetings; including the development/distribution of agendas and minutes, as required
+ Serve as a mentor to Clinical Monitoring Managers/Associate Managers, and staff to develop best practices and ensure efficient/effective monitoring activities are applied across studies
+ Serve as a Subject Matter Expert (SME) for systems/technology, development of new templates for Clinical Monitoring Department
+ Assist Associate Director/Director, Clinical Monitoring with administration and forecast of functional area budget, timelines, and performance, assist with budget planning
Personnel Management Responsibilities:
+ Ensure productivity, quality, and consistency of direct reports performance through routine review of available metrics and communication with direct reports; assist with resolution of performance issues/discussions escalated from junior Managers and ensure issues/performance discussions are escalated appropriately to the Associate Director/Director, Clinical Monitoring
+ Complete and deliver performance assessments of direct reports
+ Conduct routine one-on-one meetings with direct reports to discuss workload, performance, and provide feedback/recommendations
+ Provide guidance and coaching to direct reports to increase competencies and career development growth
+ Mentor junior managers on personnel management, as needed
+ Manage leave requests and review/approve business expenses, as required
+ Conduct assessments (onsite visit activities, in-house monitoring activities and monitoring lead function activities) of Clinical Monitoring staff
Corporate, Therapeutic, and Industry Training Responsibilities:
+ Attend relevant conferences, scientific meetings and corporate offered training sessions, as required/necessary, to remain current on therapeutic areas under study for UTC products and industry practices
+ Identify/communicate lessons learned and implement best practices to promote ongoing improvement within Clinical Monitoring/Clinical Operations
Project Duties/Responsibilities:
+ Represent Clinical Monitoring and interact with strategic partners on study teams for outsourced clinical studies
+ Provide leadership and guidance on interactions with UTC Medical Science Liaisons (MSLs) to optimize relationship with investigational sites
+ Serve as a point of escalation for Clinical Monitoring and/or staff performance issues for clinical studies
+ Provide input into the feasibility and risk assessment (initial/ongoing) of clinical protocols
+ Participate in networking activities with important institutions and investigators
+ Build and maintain long-term professional relationships with clinical investigators
+ Attend, contribute and/or present at Investigator Meetings, as necessary
+ Conduct field/central monitoring and/or Monitoring Team Lead activities (e.g. on-site visits, central data review, analytics review, site management, or monitor visit documentation review) to support monitoring activities, as necessary
+ Support the Monitoring Team Lead (MTL) or designee in the development of the monitoring/site and subject recruitment strategies; review Clinical Monitoring Plan (CMP), as necessary
+ Perform other duties as required
For this role you will need
Minimum Requirements
+ Bachelor’s Degree in biological sciences, nursing or related field
+ 10+ years of experience as a Clinical Research Associate (CRA)/CRA Manager along with prior relevant experience in pharmaceutical/biotech/medical device or CRO industry with progressive experience working in clinical trials and
+ 4+ years of relevant monitoring team/trial management experience and
+ 4+ years of experience with resource/people management, conflict/resolution management, change management, and people motivation skills
+ Demonstrated ability to effectively provide guidance and direction to others and demonstrate experience in clinical trial management, monitoring and developing study documentation (e.g. operational plans, report/letter templates and annotations, and training materials for the monitoring team)
+ Knowledge of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH) Guidelines, and Good Clinical Practices (GCP)
+ Competent end user of UTC electronic systems (Phlex eTMF, Medrio/Oracle InForm/Medidata RAVE EDC, Clario CTMS)
+ Understanding of the clinical research process; including working knowledge of clinical monitoring duties/responsibilities
+ Ability to mentor and/or coach clinical staff; problem-solving abilities to assist others to resolve/recommend solutions to clinical monitoring issues
+ Demonstrated leadership to support change management within the Clinical Monitoring function and/or collaborating with cross functional leaders for department changes
+ Effective knowledge of resource management of Clinical Monitoring staff
+ Demonstrated experience with CAPA Management
+ Good written/oral communication skills; including ability to provide training and present topics/study or department materials to an audience
+ Demonstrated leadership and good interpersonal abilities to establish and maintain effective working relationships with direct reports, coworkers, vendors, and senior management
+ Competent end user of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, TEAMs)
Preferred Qualifications
+ 1+ year of previous experience with all phases of clinical research
+ Knowledge of relevant medical/therapeutic areas for UTC and understanding medical terminology
+ Effective time management and organizational skills to manage competing priorities
The salary for this position ranges from $150,000 to $187,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients._
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics
