Associate Site Manager

1 tydzień temu


Warszawa, Mazovia, Polska TN Poland Pełny etat

Social network you want to login/join with:

Client:

Johnson and Johnson

Location:Job Category:

Other

EU work permit required:

Yes

Job Reference:

1045d86855e0

Job Views:

4

Posted:

06.03.2025

Expiry Date:

20.04.2025

Job 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.

Position Summary:

An Associate Site Manager is an entry-level site management role with typically 0-2 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. An Associate Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure.

Responsibilities:
  1. Acts as primary local company contact for assigned sites for specific trials.
  2. May participate in site feasibility and/or Site Qualification Visit.
  3. Attends/participates in investigator meetings as needed.
  4. 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.
  5. 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.
  6. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
  7. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
  8. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
  9. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented.
  10. Ensures accuracy, validity and completeness of data collected at trial sites.
  11. Ensures that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
  12. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
  13. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
  14. Active participation in regularly scheduled team meetings and trainings.
  15. Complies with relevant training requirements.
  16. Tracks costs at site level and ensure payments are made, if applicable.
  17. Establishes and maintains good working relationships with internal and external stakeholders.
Qualifications - External:
  1. A minimum of a BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience) is required.
  2. A minimum of 1 year of clinical trial monitoring experience is required.
  3. Basic working knowledge of GCP, company SOPs, local laws, and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  4. Strong IT skills in appropriate software and company systems.
  5. Willingness to travel with occasional overnight stay away from home.
  6. Proficient in speaking and writing the country language and English.
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