Drug Safety, Clinical Trial Manager at CSL

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

Could you be our next PB Clinical Trial Manager? You will be hybrid in our King of Prussia office. You will report to the PV Clinical Trial Liaison.

You will be maintain PV Operation processes for assigned CSL Global Clinical Trials and establish relationships with assigned internal/external partners that impact such processes.

For internal partners, you will be the primary PV Operations representative for the assigned CSL clinical trials, being accountable to develop applicable PV Operations processes such as SAE Reporting Plan; SAE Reconciliation Plan for each study and assist with the SAE Expedited Responsibility Reporting table.

Responsibilities:

• Be a GSPV PVIT representative to Study Execution Teams (SET)/ INSPECT working groups, to ensure necessary GSPV operational processes are established for assigned Global Clinical Trials.
• As part of the SET – review all necessary startup activities such as review of the Protocol; review of all necessary external service providers
• Initiate the set-up of the safety database for the Clinical Trial to include all relevant clinical information ensuring finalization with important team members e.g. Head of PV Systems, Project Lead Data Management and Clinical Scientists
• Collaborate with all partners to ensure requirements for Rave Safety Gateway (RSG) tasks include review of eCRFs, mapping of relevant safety information for RSG transmission; perform all testing inclusive of Dry Run & UAT
• Develop / Revise GSPV SOPs / processes associated with PV Operations for Clinical Trials
• Responsible &/or Coordination of unblinding expedited SAEs for reporting to health authorities and end of study unblinding (EOSU) within the safety database (EOSU requires coordination with Biostats team for SDTM listing).
• Attend all necessary Study Meetings (e.g., SET, Investigator Meetings etc.) providing all necessary SAE data and update on reconciliation activities, along with ensuring awareness of overall clinical trial progression and main timeframes for delivery of GSPV related activities
• Initiate Data Retrieval requests (e.g. line listings, SAE Narratives), required for monthly reconciliation, Data Monitoring Committee (DMC) meetings and ad hoc requests for data review purposes
• Establish Safety Query process within the assigned Clinical trials
• Oversee the Vendors to ensure GSPV standards are maintained for processing of SAE, AESI and pregnancy clinical trial cases and compliance to expedited reporting in clinical trials
• Prepare and Provide Study specific training to external vendors and GSPV team members involved in the given clinical trial

Qualifications:

• Bachelor's degree or equivalent in a life science discipline (e.g. nursing, biological, or pharmaceutical sciences)
• 7+ years' Pharmacovigilance experience in multinational pharmaceutical industry. 3+ years exposure to clinical trails
• Experience of local/international regulations and PV processes.
• Knowledge of local/international relevant GxP regulations, IT standards and other relevant legislations such as legislations related to privacy protection
• Experience in administration of complex data sets, in project-managing CAPA and SOP development, software applications and GxP.
• Negotiating and influencing skills

BENEFITS

• Medical, Dental Vision
• 401K
• Paid time Off

#LI-Hybrid

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!