Lead Site Contract Manager, North America Site Contracting (Oncology) - 1 of 2
Apply NowCompany: Johnson and Johnson
Location: Jacksonville, FL 32210
Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Albany, New York, United States of America, Albany, New York, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Athens, Georgia, United States of America, Baton Rouge, Louisiana, United States, Bismarck, North Dakota, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, West Virginia, United States, Cincinnati, Ohio, United States of America, Colorado Springs, Colorado, United States of America, Columbia, South Carolina, United States, Concord, New Hampshire, United States, Coppell, Texas, United States of America, Des Moines, Iowa, United States, Dover, Delaware, United States, Elk Grove Village, Illinois, United States of America, Greenwich, Connecticut, United States of America, Helena, Montana, United States, Honolulu, Hawaii, United States, Jackson, Mississippi, United States, Jacksonville, Florida, United States of America, Jefferson City, Missouri, United States {+ 25 more}
Job Description:
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for two Lead Site Contract Managers to be located remotely within the United States.
This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose:
This candidate will be responsible for the development and analysis of site contracts including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials. The lead will assist with training of staff, facilitating clear and concise communications and assist Analysts with resolution of contracting and study related issues. In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of contracts.
You will be responsible for:
Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites.
Responsible for analyzing requirements and translating into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Responsible for reviewing all study specific tracking requirements for accuracy and completeness as well as delivering against contracting cycle time targets.
Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the J&J pricing guidelines. Participate in and/or lead approval escalations as appropriate.
Provide specialized support and guidance on negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies
Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
May assist in review, authorization and/or management of payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
Exemplary customer focus with vision to drive solutions
Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS GD and operating companies. Comply with requests from QA and auditors.
Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
Qualifications / Requirements:
Education:
Minimum of Bachelor's degree is required
Required:
Minimum of 4-6 years experience in pharmaceutical or clinical research industries
Minimum of 4-6 years of working knowledge of the clinical development process with negotiation and contract experience
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
Ability to work effectively in cross functional teams
Excellent communication skills (both oral and written)
Strong initiative and proven self-starter
Strong and proven negotiation and problem resolution skills
Working knowledge of MS Office suite and database management
Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
Preferred:
Oncology experience
Previous experience working in virtual teams
The anticipated base pay range for this position in the US is $105,000 to $169,050.
The anticipated base pay range for this position in San Francisco Bay Area is $121,000 to $194,350.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on April 21, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Remote
The anticipated base pay range for this position is :
$105,000-$169,050
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Albany, New York, United States of America, Albany, New York, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Athens, Georgia, United States of America, Baton Rouge, Louisiana, United States, Bismarck, North Dakota, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, West Virginia, United States, Cincinnati, Ohio, United States of America, Colorado Springs, Colorado, United States of America, Columbia, South Carolina, United States, Concord, New Hampshire, United States, Coppell, Texas, United States of America, Des Moines, Iowa, United States, Dover, Delaware, United States, Elk Grove Village, Illinois, United States of America, Greenwich, Connecticut, United States of America, Helena, Montana, United States, Honolulu, Hawaii, United States, Jackson, Mississippi, United States, Jacksonville, Florida, United States of America, Jefferson City, Missouri, United States {+ 25 more}
Job Description:
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for two Lead Site Contract Managers to be located remotely within the United States.
This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose:
This candidate will be responsible for the development and analysis of site contracts including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials. The lead will assist with training of staff, facilitating clear and concise communications and assist Analysts with resolution of contracting and study related issues. In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of contracts.
You will be responsible for:
Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites.
Responsible for analyzing requirements and translating into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Responsible for reviewing all study specific tracking requirements for accuracy and completeness as well as delivering against contracting cycle time targets.
Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the J&J pricing guidelines. Participate in and/or lead approval escalations as appropriate.
Provide specialized support and guidance on negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies
Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
May assist in review, authorization and/or management of payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
Exemplary customer focus with vision to drive solutions
Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS GD and operating companies. Comply with requests from QA and auditors.
Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
Qualifications / Requirements:
Education:
Minimum of Bachelor's degree is required
Required:
Minimum of 4-6 years experience in pharmaceutical or clinical research industries
Minimum of 4-6 years of working knowledge of the clinical development process with negotiation and contract experience
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
Ability to work effectively in cross functional teams
Excellent communication skills (both oral and written)
Strong initiative and proven self-starter
Strong and proven negotiation and problem resolution skills
Working knowledge of MS Office suite and database management
Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
Preferred:
Oncology experience
Previous experience working in virtual teams
The anticipated base pay range for this position in the US is $105,000 to $169,050.
The anticipated base pay range for this position in San Francisco Bay Area is $121,000 to $194,350.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on April 21, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Remote
The anticipated base pay range for this position is :
$105,000-$169,050
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.