Clinical Research Leader

Job Description - Clinical Research Leader (2506232901W)

Clinical Research Leader - 2506232901W

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 www.jnj.com.

We are looking for a Clinical Research Leader who will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES:

1. Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones.
2. Oversees/executes feasibility, selection, setup, conduct, and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation, and Company Standard Operating Procedures.
3. May serve as the primary contact for clinical trial sites (e.g. site management).
4. Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
5. Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and supports publications as needed.
6. Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
7. Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
8. Interfaces, collaborates and oversees Clinical Research Associates (CRAs).
9. Oversees and supports the development and execution of Investigator agreements and trial payments.
10. Is responsible for clinical data review to prepare data for statistical analyses and publications.
11. May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits, or close out visits based on study need.
12. May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships, with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc.), contributing to cross-functional alignment.
13. May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
14. Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
15. Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs).
16. Supports planning, tracks, and manages assigned project budgets to ensure adherence to business plans.
17. Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy.
18. May serve as the clinical representative on a New Product Development team.
19. May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals.
20. May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant.
21. May conduct review of promotional materials to ensure fair balance, accuracy in clinical claims and messaging.
22. Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
23. May perform other duties assigned as needed.
24. Is responsible for communicating business-related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
25. Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
26. Should develop a strong understanding of the pipeline, product portfolio, and business needs.
27. Generally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.

Qualifications

EXPERIENCE AND EDUCATION

1. Education: Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
2. Experience: BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred. Previous experience in clinical research or equivalent is required. Experience working well with cross-functional teams is required. Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.). Clinical/medical background is a plus. Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Functional and Technical Competencies:

1. Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
2. Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects.
3. Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance to SOPs and regulations.
4. Strong presentation and technical writing skills.
5. Strong written and oral English communication skills.
6. Demonstrate competencies in the following area are required: Behave and lead in a professional and ethical manner.
7. Advanced project management skills with ability to handle multiple projects.

Leadership Competencies:

1. Ability to lead small study teams to deliver critical milestones, as may be assigned.
2. Leadership required in alignment with J&J Leadership Imperatives: Connect – Develop strong collaborative relationships with key internal and external stakeholders. Shape - Make recommendations for and actively participate and lead in departmental process improvement activities. Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations. Deliver - Strive to ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance with 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.

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.

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