Senior Local Trial Manager

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About Innovative Medicine

Position Summary:

A Senior Local Trial Manager is responsible for local management of a clinical trial in a country. The Senior Local Trial Manager acts as 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 Senior Local Trial Manager 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. A Senior Local Trial Manager may contribute to process improvement activities and the training of Clinical Trial Assistants (CTA) and Site Managers (SM). A Senior Local Trial Manager will usually perform principal responsibilities under the direct supervision of a Lead Local Trial Manager and/or Functional Manager (FM)/Clinical Research Manager (CRM).

Principal Responsibilities:

• Collaborate with FM/CRM for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable) SM and Trial Delivery Manager (TDM)/Trial Delivery Leader (TDL). Implements any local criteria for site selection. Ensure consistent conduct of Site Qualification Visits and instruct teams on appropriate follow-up of Site Qualification Visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
• Collaborates with the Program Delivery Leader (PDL) TDM/TDL 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. May require guidance from more senior LTMs or FM/CRM.
• 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. May require guidance from more senior LTMs or FM/CRM.
• 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). May require supervision and guidance from Lead LTMs or FM/CRM.
• Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the TDM/TDL and FM/CRM as needed. May require guidance from more senior LTMs or FM/CRM.
• Reviews and approves site and local vendor invoices as required. Manages local study supply as required. May require guidance from more senior LTMs or FM/CRM.
• 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 that the trial is compliant with local regulatory requirements. May require guidance from more senior LTMs or FM/CRM.
• Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits.
• Complies with relevant training requirements.
• Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
• Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders in particular investigators study trial coordinators and other site staff; and internal stakeholders including Medical Affairs and Marketing for Medical Affairs trials.
• May be asked to conduct accompanied site visits with SM as delegated by FM/CRM under the guidance of a more senior LTM.
• Contributes to process improvement.
• This is not an exhaustive comprehensive listing of job functions. May perform other duties as assigned.

Education and Experience Requirements:

• A minimum of a BA or BS degree in Pharmacy Nursing Life Sciences or related scientific field (or equivalent experience) is required.
• Minimum of 2 years of pharmaceutical and/or clinical trial experience is required. However other relevant experiences and skills may be considered by the hiring manager when considering the candidates eligibility.
• Specific therapeutic area experience will be an added advantage. Should have a basic understanding of the drug development process including GCP and local regulatory requirements
• Willingness to travel with occasional overnight stay away from home.
• Some leadership experience preferred. Computer skills required.
• Proficient in English Dutch and French.
• Drivers license required.

Please note that due to the holiday period we will start reviewing applications first in the new year.

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