Drug Safety, Clinical Trial Manager

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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

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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.
About CSL Behring

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!