Local Trial Manager
Local Trial Manager
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Job Description
At Janssen we are dedicated to addressing andsolving some of the most important unmet medical needs of our time in oncologyimmunology neuroscience infectious diseases and vaccines and cardiovascularand metabolic diseases. Driven by ourcommitment to patients we bring innovative products services and solutions topeople throughout the world. Janssen is a pharmaceutical company of Johnson& Johnson. Please visit more information
LOCAL TRIAL MANAGER
Location: Sofia
Full-timepermanent contract
The Local Trial Manager II(LTM II) is responsible for local management of a clinical trial (or MedicalAffairs data generation activity) in a country or countries. The LTM II is theprimary point of contact at a country level for assigned studies and hasoperational oversight of assigned protocol(s) from start-up through to databaselock and closeout activities as described in GCO procedural documents. The LTMII is responsible for coordinating and leading the local trial team to deliverquality data and trial documents/records that are compliant with the assignedclinical trial protocol company Standard Operating Procedures (SOPs) GoodClinical Practice (GCP) and regulatory requirements.
The LTM II activelycontributes to process improvement; training and mentoring of Clinical TrialAssistants (CTA) Site Managers (SM) and LTM I roles. The LTM II may have somesite management responsibilities.
The LTM II may also performthe role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for singlecountry as described in GCO procedural documents.
- Collaborate with Functional Manager (FM)/Clinical ResearchManager (CRM) for country protocol feasibility (if applicable) and sitefeasibility assessment in conjunction with CTA (if applicable) SM and CTM/ any local criteria for site selection. Ensure consistent conduct ofpre-trial assessment visits and instruct teams on appropriate follow-up ofpre-trial visit report and country feasibility report. Recommends suitablesites for selection to participate in trial.
- Collaborates with the Global Product Lead (GPL) CTM/GTLlocal management/Country Head and other study team member to select final sitelist.
- Contributes input to the study management documents at acountry level or initiates development of these documents for a single countrytrial as per SOPs
- Leads and coordinates local trial team activities incompliance with SOPs other procedural documents and applicable local project planning activities to meet recruitment targets and todeliver high quality data on time and within study budget. Including but notlimited to: development of local trial specific procedures and toolsrecruitment 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 requiredreporting timelines and documented as appropriate.
- Maintains and updates trial management systems. Uses studytools and management reports available to analyse trial progress.
- Monitors country progress and initiates corrective andpreventive actions (CAPA) when the trial deviates from plans and communicatesstudy progress and issues to study management teams.
- May submit requests for vendor services and may supportvendor selection.
- In certain situations may assist in negotiation of trialsite contracts and budgets. Forecasts and manages country/local trial budget toensure accurate finance reporting and trial delivered within budget. Adheresto finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. Mayschedule and conduct a local/country investigator meeting
- Conducts local trial team meetings and provides orfacilitates SM training when needed (i.e. implementation of study amendment-andchanges in study related processes).
- Reviews and approves Monitoring Visit Reports submitted bySM; identifies issues and/or trends across a trial project and escalatesdeviation issues to the CTM/GTL and FM as needed.
- Reviews and approves site and local vendor invoices asrequired. Manages local study supply as required.
- Prepares country specific informed consent in accordancewith procedural document/templates. Reviews and manages site specific informedconsent forms in accordance with SOPs other procedural documents andapplicable regulations.
- Organizes and ensures IEC/HA approvals if applicable and ensurethat the trial is in compliance with local regulatory requirements.
- Works with SM to ensure CAPA is implemented for audits andinspection or any quality related visits.
- Complies with relevant training requirements.
- Acts as subject matter expert for assigned strong therapeutic knowledge to support roles and represent GCO on cross functional teams.
- Acts as primary local/country contact for a and maintains excellent working relationships with externalstakeholders in particular investigators study trial coordinators and othersite staff; and internal stakeholders including Medical Affairs and Marketingfor Medical Affairs trials.
- Actively contributes to process improvement training andmentoring of CTAs SM and other LTMs.
- Conducts accompanied site visits with SM as delegated by FM.
- May assumes additional responsibilities or specialinitiatives such as Champion or Subject Matter Expert.
- May represents functional area in process initiatives asrequired.
- A minimum of a BA or BS degree in Life Sciences Nursing orrelated scientific field (or equivalent experience) is required.
- Minimum four years of pharmaceutical and/or clinical trialexperience is preferred (including site monitoring experience) and minimum oneto two years of project management experience in the clinical trial field.
- Native Bulgarian speaker and fluent English knowledge ofboth spoken and written.
- Solid understanding of the drug development processincluding GCP and local regulatory requirements.
- Willingness to travel with occasional overnight stay awayfrom home.
- Solid leadership skills. The ability to leadinitiative/small teams.
- Solid computer skills required.
- Excellent written and oral communication skills
- Experience in mentoring/coaching and providing training toother LTMs SMs and CTAs preferred.
- Flexible mindset and ability to work in a fast-changingenvironment.
- Ability to work on multiple trials in parallel.
- Anopportunity to be part of a global market leader
- Adynamic and inspiring working environment
- Many opportunities to work on challenging projects andassignments
- Possibilities for further personal as well as professionaldevelopment
- Many employees benefits
Required Experience:
Manager
Employment Type
Full Time
