Early Development & Clinical Pharmacology Senior Site Manager

Created by: Johnson & Johnson
Added: 24.07.2020

Advert description

Job Description

Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Within Janssen Research & Development, our Global Clinical Operations (GCO) team is responsible for all trial coordination, site management and monitoring activities across Early Development, Late Development and Medical Affairs trials across five therapeutic areas. Through more than 1.500 associates across the world, we drive the operational planning and execution of over 350 clinical trials in 40 countries. As Global Clinical Operations, we are the face of Janssen to our investigators and our patients.

Within our Global Clinical Operations Team we are currently looking for a

Early Development & Clinical Pharmacology Senior Site Manager (m/w/d)

A Site Manager II in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of complex early development and/or clinical pharmacology studies. A Site Manager II is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements, applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM) and GCDO Trial leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols.

A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.

This role will be home-based.

Main Responsibilities

  • Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
  • Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.
  • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.
  • Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site and sponsor level.
  • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • In collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensures strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried accounted and returned as applicable including maintenance of accurate and complete documentation.
  • Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.
  • Ensures that all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.
  • Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
  • Reviews investigator site File for completeness and ensures archiving retention requirements, including storage in a secure area at all times.
  • Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities.
  • Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring Visit (OSQMV).

Qualifications

  • A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
  • A minimum of 3 years of clinical trial monitoring experience is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility. Experience in monitoring ED&CP studies is mandatory
  • Specific therapeutic area experience/knowledge may be required. Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. Strong IT skills in appropriate software and company systems.

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's, Other
Level of Experience 2-5 years

Location

France, Europe