Senior Global Trial Leader

1 month ago

King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time

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.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Senior Global Trial Leader? This position is located in our King of Prussia PA, Waltham MA, or Holly Springs NC office. It is a Hybrid role. You will report to the Director, Clinical Portfolio Execution.

Responsibilities:

You will be accountable for study delivery of all operational activities and budget management related to the assigned clinical study(ies) at a global level. This includes planning, execution and management of global clinical studies to ensure successful completion following the clinical protocol. You will manage large or medium to higher complex studies or processes.

Build one or more clinical studies:

  • Lead the SET and coordinate with functional area representatives on all study related activities ensuring timelines, budget and quality are maintained.

  • Responsible for project management of a clinical study from protocol development up to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving.

  • Develop study timelines and budget

  • Develop and implement the clinical operational strategy plan, study management plan and associated documents

  • Lead vendor selection and management/oversight, including issue escalation

  • Lead a team ensuring EC/IRB and regulatory submissions

  • Develop proactive risk mitigation strategy and corrective action plan to address study issues in collaboration with SET

  • Responsible for oversight of TMF, always ensuring inspection readiness

  • Report important study performance information, including study start-up metrics, enrolment, data collection timelines/quality

  • Support audits/inspections and resolution of findings

  • Support in the development of new SOPs, guidelines and participate in working groups about new processes

Qualifications:

  • Bachelor's degree , or equivalent, in Science related discipline

  • 7+ years experience working in a Clinical Operations environment is required.

  • Global Clinical Operations experience is important.

  • Experience in budget forecasting and management

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.

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.

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