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Clinical Research Manager

3 months ago

Prague, Hlavní město Praha, Czech Republic J&J Family of Companies Full time

Clinical Research Manager W

Description

Johnson & Johnson is currently seeking a Clinical Research Manager (Manager Clinical Operations) to join us in Prague / Czechia

(Hybrid Position - Requires 3 days to be at the office)

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

Position Summary:

The Functional Manager I (FM I) is accountable for management and successful country execution of all phases of clinical trials within assigned therapeutic area(s), resource allocation, adherence to timelines and budget, compliance with Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The FM I supports the Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.

This individual is responsible for line management of Local Trial Managers (LTMs), CRAs, Clinical Trial Assistants and/or other GCO(Global Clinical Operations) staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements.

Principal Responsibilities:

  1. Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
  2. Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
  3. Interview, hire, develop and train staff.
  4. Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports' training compliance, as required.
  5. Support local implementation of organizational changes and effectively communicate on priority shifts.
  6. Review and approve expenses in compliance with the company policies.
  7. Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
  8. Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
  9. Define, execute or support of long term strategy in alignment with GCO, Global Development and Janssen R&D strategies to position the local and global GCO organization for success.
  10. Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness
  11. Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.
  12. Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
  13. Accountable for robust feasibility process and oversight of site selection to deliver on country commitments and strategic goals.
  14. Support regular metrics review and drive follow-up actions.
  15. Contribute to development, evaluation and implementation of new processes and systems to improve study management.
  16. Ensure adequate quality oversight.
  17. Foster a culture of continuous improvement and innovation within the local GCO team.
  18. Model Credo based culture within the local GCO team.

Qualifications

Education and Experience Requirements:

Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.

Experience in mentoring/coaching others (line management experience desirable). Skilled in leading, hiring, training, developing and evaluating people. Solid decision-making and financial management skills.

Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required.

Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations.

Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.).

Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.

Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

DE&I 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.

Primary Location Europe/Middle East/Africa-Czech Republic-Prague-Prague

Organization Janssen-Cilag .s.r.o (8397)

Job Function Clinical/Medical Operations

Req ID: W