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/. 

This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical RD Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES RESPONSIBILITIES: Under general direction and in accordance with all applicable federal, state and locallaws/regulations and Corporate Johnson Johnson, procedures and guidelines, this position:
 Serves as a Senior Clinical Research Specialist within the Clinical RD Department to supportexecution of company sponsored clinical trials, ensuring compliance with timelines and studymilestones.
 Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within theallocated countries, in accordance with the ICH-GCP, applicable legislation and CompanyStandard Operating Procedures;
 May serve as the primary contact for clinical trial sites (e.g. site management);
 Contributes towards development of clinical trial documents (e.g. study protocol, informedconsents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….);
 Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation throughposting of results and support publications as needed;
 Manages/oversees ordering, tracking, and accountability of investigational devices and trialmaterials;
 Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and companypersonnel;
 Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
 Oversees and supports the development and execution of Investigator agreements and trialpayments;
 Is responsible for clinical data review to prepare data for statistical analyses and publications;
 May perform monitoring activities including site qualification visits, site initiation visits, interimmonitoring visits or close out visits based on study need;
 May contribute to the development and delivery of appropriate global evidence generationstrategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
 May provide on-site procedural protocol compliance and data collection support to the clinicaltrial sites;
 Contributes to the critical assessment of the literature and to the interpretations anddisseminations of all evidence generated;
 Contributes to delivery of assigned clinical projects, through effective partnership with the studycore team leading to delivery of clinical project commitments (deliver on time, within budget andin compliance with regulations and SOPs);
 May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCFEvaluation Reports (ER) within the defined timelines and review/update at planned intervals;May assist with maintaining the overview to assure (study) commitments are timely and properlymet by coordination of specific documentation and contribution to cross-functional review ofassociated documents where relevant;
 Supports project/study budget activities;
 Mentors team members;
 May perform other duties assigned as needed;
 Is responsible for communicating business related issues or opportunities to next managementlevel. Function as a reliable, trusted resource of accurate, up-to-date project knowledge asrequested by key stakeholders;
 Is responsible for ensuring personal and company compliance with all Federal, State, local andcompany regulations, policies and procedures;
 Should develop a strong understanding of the pipeline, product portfolio and business needs;
 Generally manages work with supervision, dependent on project complexity. Independentdecision-making for simple and more advanced situations but requires guidance for complexsituations.

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/. 

This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical RD Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES RESPONSIBILITIES: Under general direction and in accordance with all applicable federal, state and locallaws/regulations and Corporate Johnson Johnson, procedures and guidelines, this position:
 Serves as a Senior Clinical Research Specialist within the Clinical RD Department to supportexecution of company sponsored clinical trials, ensuring compliance with timelines and studymilestones.
 Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within theallocated countries, in accordance with the ICH-GCP, applicable legislation and CompanyStandard Operating Procedures;
 May serve as the primary contact for clinical trial sites (e.g. site management);
 Contributes towards development of clinical trial documents (e.g. study protocol, informedconsents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….);
 Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation throughposting of results and support publications as needed;
 Manages/oversees ordering, tracking, and accountability of investigational devices and trialmaterials;
 Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and companypersonnel;
 Interfaces, collaborates and oversees Clinical Research Associates (CRAs);
 Oversees and supports the development and execution of Investigator agreements and trialpayments;
 Is responsible for clinical data review to prepare data for statistical analyses and publications;
 May perform monitoring activities including site qualification visits, site initiation visits, interimmonitoring visits or close out visits based on study need;
 May contribute to the development and delivery of appropriate global evidence generationstrategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
 May provide on-site procedural protocol compliance and data collection support to the clinicaltrial sites;
 Contributes to the critical assessment of the literature and to the interpretations anddisseminations of all evidence generated;
 Contributes to delivery of assigned clinical projects, through effective partnership with the studycore team leading to delivery of clinical project commitments (deliver on time, within budget andin compliance with regulations and SOPs);
 May assist with the development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCFEvaluation Reports (ER) within the defined timelines and review/update at planned intervals;May assist with maintaining the overview to assure (study) commitments are timely and properlymet by coordination of specific documentation and contribution to cross-functional review ofassociated documents where relevant;
 Supports project/study budget activities;
 Mentors team members;
 May perform other duties assigned as needed;
 Is responsible for communicating business related issues or opportunities to next managementlevel. Function as a reliable, trusted resource of accurate, up-to-date project knowledge asrequested by key stakeholders;
 Is responsible for ensuring personal and company compliance with all Federal, State, local andcompany regulations, policies and procedures;
 Should develop a strong understanding of the pipeline, product portfolio and business needs;
 Generally manages work with supervision, dependent on project complexity. Independentdecision-making for simple and more advanced situations but requires guidance for complexsituations.

EXPERIENCE AND EDUCATION:
1. Education:
 Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, orBiological Science required.
2. Experience:
 BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevantexperience preferred.
 Previous experience in clinical research or equivalent is required.
 Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO14155, MDR, MEDDEV,…).
 Clinical/medical background is a plus.
 Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES andAFFILIATIONS
Functional and Technical Competencies:
 Good understanding of clinical research science and processes, clinical trends, and globalclinical trial regulations;
 Proven track record in supporting delivery of clinical projects within clinical/ surgical researchsetting, on time, within budget and in compliance to SOPs and regulations;
 Good presentation and technical writing skills;
 Good written and oral English communication skills;

Leadership Competencies:Ability to lead small study teams to deliver critical milestones, as may be assigned.Leadership required in alignment with JJ Leadership Imperatives:
 Connect - Develop collaborative relationships with key internal and external stakeholders.
 Shape - Make recommendations for and actively participate in departmental processimprovement activities.
 Lead - Take ownership in critical scientific thinking and development of self and engage intransparent and constructive conversations.
 Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budgetand in compliance to SOPs and regulations.

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.

EXPERIENCE AND EDUCATION:
1. Education:
 Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, orBiological Science required.
2. Experience:
 BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevantexperience preferred.
 Previous experience in clinical research or equivalent is required.
 Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO14155, MDR, MEDDEV,…).
 Clinical/medical background is a plus.
 Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES andAFFILIATIONS
Functional and Technical Competencies:
 Good understanding of clinical research science and processes, clinical trends, and globalclinical trial regulations;
 Proven track record in supporting delivery of clinical projects within clinical/ surgical researchsetting, on time, within budget and in compliance to SOPs and regulations;
 Good presentation and technical writing skills;
 Good written and oral English communication skills;

Leadership Competencies:Ability to lead small study teams to deliver critical milestones, as may be assigned.Leadership required in alignment with JJ Leadership Imperatives:
 Connect - Develop collaborative relationships with key internal and external stakeholders.
 Shape - Make recommendations for and actively participate in departmental processimprovement activities.
 Lead - Take ownership in critical scientific thinking and development of self and engage intransparent and constructive conversations.
 Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budgetand in compliance to SOPs and regulations.

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.