Senior Global Trial Leader

1 month ago

King of Prussia, 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.

Do work that matters at CSL Behring

  • Senior Global Trial Leader

    1 month ago

    King of Prussia, 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...

  • Senior Global Trial Leader

    3 weeks ago

    King of Prussia, United States CSL 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...

  • Senior Global Trial Leader

    4 weeks ago

    King Of Prussia, 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...

  • Senior Global Trial Leader

    1 month ago

    King of Prussia, 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...

  • Senior Global Trial Leader

    1 month ago

    King of Prussia, 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...

  • Senior Global Trial Leader

    2 months ago

    King of Prussia, Pennsylvania, 19406, 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...

  • Senior Global Trial Leader

    4 weeks ago

    King of Prussia, 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...

  • Senior Global Trial Leader

    4 weeks ago

    King of Prussia, 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...

  • Senior Global Trial Leader

    1 month ago

    Americas, US-PA, King of Prussia, CSL Behring 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...

  • Clinical Trial Supply Senior Study Manager

    1 month ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe Clinical Trial Supply (CTS) Senior Study Manager manages the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Senior Study Manager independently leads clinical studies to ensure compliant, supply of study medication and ancillary materials for our patients. Responsibilities include...

  • Senior Manager, Global Regulatory CTA Therapeutic Area Lead

    3 weeks ago

    King of Prussia, United States CSL Full time

    The Global Regulatory CTA Therapeutic Area Lead is a recognized SME in CTA and is responsible for the global management of Clinical Trial Authorizations (CTAs) with the view to obtain CTA approvals in the fastest and most efficient way while ensuring quality documentation. The Senior GRSL develops the CTA submission strategy of large and/or complex projects,...

  • Global Product Leader

    4 days ago

    King of Prussia, United States CSL Behring Full time

    The Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...

  • Global Product Leader

    5 days ago

    King of Prussia, United States CSL Behring Full time

    The Opportunity:As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You...

  • Project Manager Adaptive Clinical Trial Technologies

    1 month ago

    King of Prussia, 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...

  • Senior Biostatistics Leader

    4 weeks ago

    King of Prussia, Pennsylvania, United States Aequor Technologies Full time

    Job Summary:As a Senior Biostatistics Leader at Aequor Technologies, you will be responsible for leading late phase project and regulatory submissions. You will represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and define statistical strategy and ensure appropriate statistical methodologies are applied to study design...

  • Senior Contract Manager

    4 weeks ago

    King of Prussia, Pennsylvania, United States Parexel International Corporation Full time

    About the RoleWe are seeking a highly experienced Senior Contract Manager to join our global team at Parexel International Corporation. This role is responsible for ensuring consistent management of all contracts, developing account-specific standards, and negotiating contract documents.Job DescriptionLine Management responsibilities, including performance...

  • Senior Biostatistics Leader

    1 week ago

    King of Prussia, Pennsylvania, United States Aequor Technologies Full time

    Aequor Technologies seeks an experienced Senior Biostatistics Leader to lead late-phase projects and regulatory submissions. The ideal candidate will have a strong background in biostatistics, excellent communication skills, and the ability to work effectively with cross-functional teams.">Responsibilities:Develop and implement statistical strategies for...

  • Project Manager Adaptive Clinical Trial Technologies

    3 weeks ago

    King of Prussia, United States CSL 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...

  • Project Manager Adaptive Clinical Trial Technologies

    4 weeks ago

    King of Prussia, 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...

  • Project Manager Adaptive Clinical Trial Technologies

    4 weeks ago

    King of Prussia, 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...