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Senior Local Trial Manager

hace 4 meses

Madrid, España Johnson & Johnson A tiempo completo

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. _
- We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences _
- That is why we in Spain are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. _
- Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong” _

The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs
data generation activity) in a country or countries. The LTM III 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 III 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 III role actively leads or contributes to process improvement; training and mentoring of other LTM s
and Site Managers (SM).

Compared to LTM I and LTM II roles, an LTM III is often assigned to more complex protocols and can work
across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs.
The LTM III 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:

- 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.
- Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other
study team member to select final site list.
- 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.
- 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.
- 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.
- Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress.
- 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.
- May submit requests for vendor services and may support vendor selection.
- 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.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
- 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).
- 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.
- Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
- Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
- Organizes and ensures IEC/HA approvals, if applicable, and ensure t