Oncology Clinical Team Lead II - CRO - Remote US

Work from Home

Lebanon Tennessee

United States

Healthcare - Physician
(No Timezone Provided)

Description

Introduction

Do you have the career opportunities as an Oncology Clinical Team Lead II you want with your current employer? We have an exciting opportunity for you to join our Sarah Cannon CRO, which is part of the nation's leading provider of healthcare services, HCA Healthcare.

Benefits

We are committed to providing our employees with the support they need by offering eligible colleagues an attractive benefits package that includes medical, wellbeing, dental and vision benefits along with other unique benefits including:

  • Medical, Dental, Vision, Life Insurance and Flexible Spending
  • Paid Time Off (PTO) and Personal Leave
  • 401K (100% annual match - 3% to 9% of pay based on years of service)
  • Academic Assistance and Reimbursements for Tuition and Student Loans
  • Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
  • HomeAuto, and Pet Insurance
  • Employee Stock Purchase Program (ESPP)
  • Short Term Long Term Disability coverage
  • Adoption Assistance
  • Legal Benefits and lots more!

Learn more about Employee Benefits

Our teams are a committed, caring group of colleagues where your passion for creating positive patient interactions are valued! If you are dedicated to caring for the well-being of others, this could be your next opportunity!

Job Summary 

Our Clinical Team Lead II (CTL II) is knowledgeable in clinical project management with a strong background in clinical research, expert knowledge of ICH-GCP, applicable Federal and international research guidelines and regulatory requirements. Responsibilities are scoped from project initiation to completion with a key focus on meeting timelines, providing oversight of the Clinical Research Associate (CRA) team, and working with cross-functional teams on key deliverables.

Duties include and are not limited to

  • Contribute to and present at project Kick-off Meetings and Investigator Meetings as needed.
  • Assess project needs for clinical resource forecasting to ensure timelines and deliverables are met while adhering to quality standards and supporting financial targets.
  • Plan and track clinical activities throughout the lifecycle of assigned study projects
  • Proactively identify and present project-related risks and support resolutions both in and across functions
  • Create and maintain Clinical Project Documents, including but not limited to clinical study plans, trackers, and team training materials
  • Develop and conduct study team training
  • Review performance metrics for assigned CRA team, including but not limited to site visit reports and other clinical study deliverables
  • Manage enrollment and, as applicable, slot allocation for sites assigned to designated trial.
  • Work directly with data management and project team to facilitate timely data entry and cleaning.
  • Initiate and/or support improvements to processes, tools, and forms to enhance the efficiency and quality of the work performed on assigned projects
  • Create a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of project progress
  • Identify, address, and, as applicable, escalate clinical study risks and/or issues to facilitate resolution
  • Provide oversight of Investigator Site File in the TMF/eTMF and perform inspection readiness per SOP.
  • Review monitoring reports and track ongoing action items to ensure timely follow up by CPA and CRA.
  • Conduct CRA, sponsor, and team meetings as needed
  • Ensure awareness of project-specific quality and performance standards and confirm that these are adequately documented, communicated, and understood.

Qualifications needed

  • Bachelor’s Degree (4-year program)
  • 5 previous work experience within the clinical research industry in a clinical management role.
  • Minimum 2-3 years’ direct Oncology experience in Phases I-II
  • Demonstrated business knowledge and strategic understanding of how cross-functional teams jointly achieve project objectives and goals, utilizing experience across organizations, processes, customers, and key business drivers to increase effectiveness.
  • Strong understanding of clinical trials, study design, and drug development process
  • Strong knowledge of scientific, medical, and regulatory terms 

It would be preferred if you had

  • Master’s Degree (2-year program)
  • 7 years direct oncology experience in Phase l – II, in solid and liquid tumor types


Sarah Cannon is the Cancer Instituteof HCA Healthcare. We offerintegrated cancer services with easy access to cutting-edge therapies for communitiesacross the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation. Ournurses are oncology-trained. Morethan 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network.Through its services, Sarah Cannonprovides state-of-the-art cancer care for hundreds of thousands of patients. Ourcancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.

HCA Healthcare has been named one of the World's Most Ethical Companies by Ethisphere Institutefor over a decade.  In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for thedelivery of charitable care, uninsured discounts, and other uncompensated expenses.


"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder

If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Oncology Clinical Team Lead II - CRO - Remote US opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Oncology Clinical Team Lead II - CRO - Remote US

Work from Home

Lebanon Tennessee

United States

Healthcare - Physician

(No Timezone Provided)

Description

Introduction

Do you have the career opportunities as an Oncology Clinical Team Lead II you want with your current employer? We have an exciting opportunity for you to join our Sarah Cannon CRO, which is part of the nation's leading provider of healthcare services, HCA Healthcare.

Benefits

We are committed to providing our employees with the support they need by offering eligible colleagues an attractive benefits package that includes medical, wellbeing, dental and vision benefits along with other unique benefits including:

  • Medical, Dental, Vision, Life Insurance and Flexible Spending
  • Paid Time Off (PTO) and Personal Leave
  • 401K (100% annual match - 3% to 9% of pay based on years of service)
  • Academic Assistance and Reimbursements for Tuition and Student Loans
  • Employee Discounts including Tickets, Retail, Mental Health Apps, Education Apps, Identity Theft Protection etc.
  • HomeAuto, and Pet Insurance
  • Employee Stock Purchase Program (ESPP)
  • Short Term Long Term Disability coverage
  • Adoption Assistance
  • Legal Benefits and lots more!

Learn more about Employee Benefits

Our teams are a committed, caring group of colleagues where your passion for creating positive patient interactions are valued! If you are dedicated to caring for the well-being of others, this could be your next opportunity!

Job Summary 

Our Clinical Team Lead II (CTL II) is knowledgeable in clinical project management with a strong background in clinical research, expert knowledge of ICH-GCP, applicable Federal and international research guidelines and regulatory requirements. Responsibilities are scoped from project initiation to completion with a key focus on meeting timelines, providing oversight of the Clinical Research Associate (CRA) team, and working with cross-functional teams on key deliverables.

Duties include and are not limited to

  • Contribute to and present at project Kick-off Meetings and Investigator Meetings as needed.
  • Assess project needs for clinical resource forecasting to ensure timelines and deliverables are met while adhering to quality standards and supporting financial targets.
  • Plan and track clinical activities throughout the lifecycle of assigned study projects
  • Proactively identify and present project-related risks and support resolutions both in and across functions
  • Create and maintain Clinical Project Documents, including but not limited to clinical study plans, trackers, and team training materials
  • Develop and conduct study team training
  • Review performance metrics for assigned CRA team, including but not limited to site visit reports and other clinical study deliverables
  • Manage enrollment and, as applicable, slot allocation for sites assigned to designated trial.
  • Work directly with data management and project team to facilitate timely data entry and cleaning.
  • Initiate and/or support improvements to processes, tools, and forms to enhance the efficiency and quality of the work performed on assigned projects
  • Create a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of project progress
  • Identify, address, and, as applicable, escalate clinical study risks and/or issues to facilitate resolution
  • Provide oversight of Investigator Site File in the TMF/eTMF and perform inspection readiness per SOP.
  • Review monitoring reports and track ongoing action items to ensure timely follow up by CPA and CRA.
  • Conduct CRA, sponsor, and team meetings as needed
  • Ensure awareness of project-specific quality and performance standards and confirm that these are adequately documented, communicated, and understood.

Qualifications needed

  • Bachelor’s Degree (4-year program)
  • 5 previous work experience within the clinical research industry in a clinical management role.
  • Minimum 2-3 years’ direct Oncology experience in Phases I-II
  • Demonstrated business knowledge and strategic understanding of how cross-functional teams jointly achieve project objectives and goals, utilizing experience across organizations, processes, customers, and key business drivers to increase effectiveness.
  • Strong understanding of clinical trials, study design, and drug development process
  • Strong knowledge of scientific, medical, and regulatory terms 

It would be preferred if you had

  • Master’s Degree (2-year program)
  • 7 years direct oncology experience in Phase l – II, in solid and liquid tumor types


Sarah Cannon is the Cancer Instituteof HCA Healthcare. We offerintegrated cancer services with easy access to cutting-edge therapies for communitiesacross the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation. Ournurses are oncology-trained. Morethan 1,200 stem cell transplants are performed yearly within the Sarah Cannon Blood Cancer Network.Through its services, Sarah Cannonprovides state-of-the-art cancer care for hundreds of thousands of patients. Ourcancer experts are collaborating and sharing best practices. We address every aspect of the cancer journey, from screening anddiagnosis through treatment and survivorship.

HCA Healthcare has been named one of the World's Most Ethical Companies by Ethisphere Institutefor over a decade.  In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for thedelivery of charitable care, uninsured discounts, and other uncompensated expenses.


"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder

If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Oncology Clinical Team Lead II - CRO - Remote US opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.