Site Manager

Darwoft; Buenos Aires; Presencial; ARS 12.500.000 - 15.000.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Buenos Aires is seeking an Associate, Site Manager to ensure clinical trial sites are ready for inspections, maintaining compliance with all protocols and regulations. This entry-level position requires a bachelor's degree and excellent communication skills. Responsibilities include managing the site’s interactions, ensuring training for staff, and documenting all trial-related activities. Join us in our mission to develop groundbreaking medicines while championing patient care.

Servicios

Remote work options

Career development opportunities

Formación

• 0-2 years of experience in a clinical trial setting preferred.
• Strong understanding of Good Clinical Practice (GCP).
• Must be detail-oriented with strong problem-solving skills.

Responsabilidades

• Act as primary contact for assigned trial sites.
• Ensure compliance with clinical trial protocols and regulations.
• Manage site initiation, monitoring, and close-out activities.

Conocimientos

Communication

Attention to detail

Teamwork

Educación

Bachelor's degree or equivalent

Descripción del empleo

Job Function: R&D Operationsb>Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Buenos Aires, Argentina

About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: 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. 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. Occasionally may require assistance or oversight from Lead, Site Manager or LTM.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in the shortest possible timeframe.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
7. Ensures site study supplies (such as Non‑Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies.
10. Ensures site staff complete data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites.
12. 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. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
13. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
14. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow‑up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
15. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
16. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
17. Active participation in regularly scheduled team meetings and trainings. Provides feedback as appropriate. May be asked to lead/provide leadership at these meetings.
18. Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
19. 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).
20. Prepares trial sites for close out, conducts final close out visit.
21. Tracks costs at site level and ensures payments are made, if applicable.
22. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
23. May participate in the Health Authority (HA) and IEC/IRB submission and noti