Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Investigational Clinical Trial (CT) Management located in Horsham, PA.
The Manager, Investigational Clinical Trial (CT) Management directs and supervises the operational and management activities of a team of Drug Safety Associates (DSAs) dedicated to processing investigational CT Individual Case Safety Reports (ICSRs), including activities required to meet Serious Unexpected Suspected Adverse Reaction (SUSAR) reporting (requesting single case unblinding, preparation of analysis of similar events (AOSE), etc.) at defined Case Processing Centers. Liaises with staff in Global Medical Safety Operations (GMSO) functions, Global Case Management (GCM) Case Receipt, Safety Reporting, Medical Safety Surveillance & Insight (MSSI) and PV Sciences (PVER) as appropriate to facilitate compliant, timely and efficient end-to-end case management of investigational CT ICSRs. Partners with stakeholders from key Clinical Development Organizations, including third party partners conducting clinical trial activities on behalf of Clinical, to ensure accurate and timely submission of clinical trial ICSRs.
Manager, Investigational Clinical Trial (CT) Management will:
- Manages personnel in daily activities relating to case processing activities providing guidance and support to team members.
- Monitor team member ICSR quality and compliance, with an emphasis on SUSARs accuracy, completeness (e.g. case narratives, coding activities, AOSE, etc.) to maintain regulatory compliance and strong partnerships with stakeholders (GCO).
- Monitor defined Quality Control procedures (e.g. quality check line listings, oversight activities, etc.) to ensure timely completion and resolution of discrepancies.
- Performs performance management activities, including establishment and monitoring progress of team member goals and objectives, staff development plans, and execution of those plans for direct reports.
- • Evaluates and identifies staff training needs to ensure all personnel trained within team and is responsible for oversight of training compliance of direct reports.
- Provide strategic resource planning with counterparts to manage intermittent bolus activities, such as SAE Reconciliation and interim/end of study unblinding activities escalating resource needs above defined sourcing levels to identify alternate options (e.g. supplemental sourcing strategies)
- Provide Subject Matter Expertise in operational case processing activities associated with Clinical trial activities (or other functional expertise).
- Ensure Case Processing team has awareness of case processing obligations and timelines associated with Clinical Trial Agreements (CTA), Pharmacovigilance Agreements (PVA), Collaboration Agreements to ensure safety data exchange within defined timelines
- Participate in Pharmacovigilance Operational Team meetings (PVOT)
- Provides strategic leadership to Managers and staff within Case Processing, GMSO.
- Contributes to development and implementation of strategic direction for case processing functions
- Supports and deputizes for Global Director Case Processing as Supports Associate Director/Director/Sr. Director in internal audits and external inspections.
- BS degree in health-related field is required; Licensed RN, PhD, PharmD or other related scientific degree is preferred
- A minimum of 5 years of industry and/or clinical experience with a focus on pharmaceutical safety related areas is required
- Individual and aggregate reports experience is preferred
- Extensive knowledge and experience with safety reporting and regulatory compliance, including international safety reporting regulations through-out product life cycle (investigational and post-marketing) is required
- Previous experience in a relevant management role allocating resources and provide personnel management is preferred
- Proven experience evaluating processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance is required
- Experience organizing training activities and train personnel on pharma safety topics is preferred
- Strong experience using MS Office and familiarity with safety systems required
- This position will be located in Horsham, PA and requires less than 10% travel
United States-Pennsylvania-Horsham-100 Tournament Drive
Janssen Research & Development, LLC (6084)
Drug & Product Safety Operations