Local Trial Manager

**Local Trial Manager**
**-**
**2306137880W**

**Descripción**

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The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), cardiovascular and metabolic diseases (e.g., diabetes) and Pulmonary Arterial Hypertension (PAH) and Rare Diseases.

Position Summary:
The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs
data generation activity) in a country or countries. The LTM II is the primary point of contact at a country
level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to
database lock and closeout activities as described in GCO procedural documents. The LTM II is responsible
for coordinating and leading the local trial team to deliver quality data and trial documents/records that are
compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good
Clinical Practice (GCP), and regulatory requirements.
The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants
(CTA), Site Managers (SM) and LTM I roles. The LTM II may have some site management responsibilities.
The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single
country as described in GCO procedural documents.

Principal Responsibilities:
1. Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol
feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and
CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial
assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country
feasibility report. Recommends suitable sites for selection to participate in trial.
2. Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other
study team member to select final site list.
3. Contributes input to the study management documents at a country level or initiates development of
these documents for a single country trial, as per SOPs
4. Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents
and applicable regulations. Leads local project planning activities to meet recruitment targets and to
deliver high quality data on time and within study budget. Including but not limited to: development of
local trial specific procedures and tools, recruitment planning, contingency and risk management, and
budget forecasting.
5. 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.
6. Maintains and updates trial management systems. Uses study tools and management reports available
to analyse trial progress
7. Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates
from plans and communicates study progress and issues to study management teams.
8. May submit requests for vendor services and may support vendor selection.
9. In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages
country/local trial budget to ensure accurate finance reporting and trial delivered -within budget.
Adheres to finance reporting deliverables and timelines.
10. Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country
investigator meeting
11. Conducts local trial team meetings and provides or facilitates SM training when needed (i.e.
implementation of study amendment-and changes in study related processes).
12. Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a
trial project and escalates deviation issues to the CTM/GTL and FM as needed
13. Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
14. Prepare