Johnson Johnson is currently seeking a Lead Site Manager - Lead Clinical Research to join us located in Warsaw / Poland.
About Johnson Johnson
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/.
Description:
A Lead, Site Manager is considered as the most senior site management role with typically more than 6 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. Additionally, a Lead, Site Manager is generally expected to have outstanding capability to engage with key sites and their respective personnel.
A Lead Site Manager ensures inspection readiness at trial sites by adhering to clinical trial protocols, company SOPs, GCP, and relevant regulations from start-up to site closure. Responsibilities include site selection, qualification assessment, subject recruitment and retention planning, site initiation, monitoring (both on-site and remote), and close-out activities. The Lead Site Manager collaborates with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) for effective site management while executing activities related to assigned protocols.
A Lead, Site Manager is expected to lead process improvements at country, regional, and global levels as well as training and mentoring of other Site Managers.
A Lead, Site Manager is expected to operate independently and be able to perform clinical trial tasks proficiently and is expected to identify opportunities for streamlining processes.
A Lead, Site Manager can support leadership at a study level as requested.
Principal Responsibilities:
1. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with great proficiency. Also expected to oversee, train, mentor more junior Site Manager and support functional manager with completion of junior site manager accompanied site visits (ASVs) as required.
2. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. May be required to support LTM in drafting country level recruitment strategy and contingency planning.
3. Leads collaboration with LTM for documenting and communicating site/study progress and issues to trial central team, proposing solutions and strategies for improvement and leads additional country insight gathering.
4. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. Compliance Monitoring Visit (CMV). May be required to oversee audit and inspection preparation by Associate SM.
5. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May be required to prepare communications to all sites within the country. May be required to function as Site Engagement Lead across studies at a site.
6. Acts as a point of contact in site management practices. Able to provide authoritative insights, expert advice and share best practices
7. Will routinely be assigned as a coach and mentor to a less experienced site manager.
8. Expected to contribute to process improvement and training.
9. Routinely requires to leads and/or participates in special initiatives as assigned.
10. Will routinely be expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Johnson Johnson is currently seeking a Lead Site Manager - Lead Clinical Research to join us located in Warsaw / Poland.
About Johnson Johnson
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/.
Description:
A Lead, Site Manager is considered as the most senior site management role with typically more than 6 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. Additionally, a Lead, Site Manager is generally expected to have outstanding capability to engage with key sites and their respective personnel.
A Lead Site Manager ensures inspection readiness at trial sites by adhering to clinical trial protocols, company SOPs, GCP, and relevant regulations from start-up to site closure. Responsibilities include site selection, qualification assessment, subject recruitment and retention planning, site initiation, monitoring (both on-site and remote), and close-out activities. The Lead Site Manager collaborates with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) for effective site management while executing activities related to assigned protocols.
A Lead, Site Manager is expected to lead process improvements at country, regional, and global levels as well as training and mentoring of other Site Managers.
A Lead, Site Manager is expected to operate independently and be able to perform clinical trial tasks proficiently and is expected to identify opportunities for streamlining processes.
A Lead, Site Manager can support leadership at a study level as requested.
Principal Responsibilities:
1. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk-based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. Able to implement and execute all tasks independently with great proficiency. Also expected to oversee, train, mentor more junior Site Manager and support functional manager with completion of junior site manager accompanied site visits (ASVs) as required.
2. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. May be required to support LTM in drafting country level recruitment strategy and contingency planning.
3. Leads collaboration with LTM for documenting and communicating site/study progress and issues to trial central team, proposing solutions and strategies for improvement and leads additional country insight gathering.
4. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. Compliance Monitoring Visit (CMV). May be required to oversee audit and inspection preparation by Associate SM.
5. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. May be required to prepare communications to all sites within the country. May be required to function as Site Engagement Lead across studies at a site.
6. Acts as a point of contact in site management practices. Able to provide authoritative insights, expert advice and share best practices
7. Will routinely be assigned as a coach and mentor to a less experienced site manager.
8. Expected to contribute to process improvement and training.
9. Routinely requires to leads and/or participates in special initiatives as assigned.
10. Will routinely be expected to assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Education and Experience Requirements:
§ A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
§ A minimum of 6 years of clinical trial monitoring experience is required. 8-10 years of clinical trial monitoring experienced is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
§ Strong Asset:Experience in shaping and cultivating relationships with clinical sites, is highly desirable. However, this experience is not a strict prerequisite for the position. We welcome candidates who may possess relevant skills and attributes, even if they do not have direct experience in this area.
§ Experience in mentoring/coaching and providing training to others SM. Strong leadership skills, ability to lead initiatives, to act as a lead SM.
§ Specific therapeutic area experience, knowledge or expertise is expected.
§ Expert knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. .
§ Willingness to travel with occasional/regular overnight stay away from home depending on the region.
§ Proficient in speaking and writing the country language and English.
§ Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
§ Demonstrated capability to consistently deliver clinical trials of high complexity or high degree of difficulty. Able to anticipate obstacles and proposed solutions to manage them effectively.
§ High degree of competency, interest and aspiration to be a career Site Manager.
§ Demonstrated strong site engagement/site relationship capability especially with identified key/strategic sites.
- Demonstrated the following skills in the context of building relationships with clinical sites.
- Strategic Thinking: Skill in developing long-term strategies that align with both the company’s and sites' goals.
- Communication Skills: Excellent verbal and written communication abilities to effectively convey ideas and information.
- Negotiation Skills: Proficiency in negotiating terms and agreements
- Customer Focus: A strong commitment to understanding and meeting the needs of the sites.
- Problem-solving abilities: Identifying issues and developing effective solutions quickly.
- Analytical Skills: Ability to analyze data and trends to inform decision-making and strategy.
- Adaptability: Flexibility to adjust strategies and approaches based on changing environment
About Johnson Johnson
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 athttps://www.jnj.com/.
Johnson Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visitwww.careers.jnj.com.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
DEI Statement
For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.
Education and Experience Requirements:
§ A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience) is required.
§ A minimum of 6 years of clinical trial monitoring experience is required. 8-10 years of clinical trial monitoring experienced is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
§ Strong Asset:Experience in shaping and cultivating relationships with clinical sites, is highly desirable. However, this experience is not a strict prerequisite for the position. We welcome candidates who may possess relevant skills and attributes, even if they do not have direct experience in this area.
§ Experience in mentoring/coaching and providing training to others SM. Strong leadership skills, ability to lead initiatives, to act as a lead SM.
§ Specific therapeutic area experience, knowledge or expertise is expected.
§ Expert knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. .
§ Willingness to travel with occasional/regular overnight stay away from home depending on the region.
§ Proficient in speaking and writing the country language and English.
§ Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.
§ Demonstrated capability to consistently deliver clinical trials of high complexity or high degree of difficulty. Able to anticipate obstacles and proposed solutions to manage them effectively.
§ High degree of competency, interest and aspiration to be a career Site Manager.
§ Demonstrated strong site engagement/site relationship capability especially with identified key/strategic sites.
- Demonstrated the following skills in the context of building relationships with clinical sites.
- Strategic Thinking: Skill in developing long-term strategies that align with both the company’s and sites' goals.
- Communication Skills: Excellent verbal and written communication abilities to effectively convey ideas and information.
- Negotiation Skills: Proficiency in negotiating terms and agreements
- Customer Focus: A strong commitment to understanding and meeting the needs of the sites.
- Problem-solving abilities: Identifying issues and developing effective solutions quickly.
- Analytical Skills: Ability to analyze data and trends to inform decision-making and strategy.
- Adaptability: Flexibility to adjust strategies and approaches based on changing environment
About Johnson Johnson
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 athttps://www.jnj.com/.
Johnson Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visitwww.careers.jnj.com.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
DEI Statement
For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson Johnson, we all belong.