Lead Clinical Oversight Manager

7 days 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 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 Lead Clinical Oversight Manager? The job is located in the King of Prussia PA, Waltham, MA, Holly Springs, NC or Kankakee IL office. This is a hybrid position. You will report to the Regional Head, Site Partnerships.

Responsibilities:

You will provide either leadership to, and management of a clinical program in a designated Therapeutic Area (TA) or is a team member within a function that supports the delivery of the portfolio. Accountable for all clinical program or functional deliverables. These responsibilities include Study Operations, Business Operations and Compliance.Ensure all activities that support the TA model are planned following the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.Help negotiate CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. Guide ownership of all deliverables through oversight and governance of the vendors.At a study level, responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Director, ClinOps Lead and the clinical teams.You will develop or help develop the processes (e.g. eTMF) and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality standards. Manage internal quality processes following defined standards to ensure that quality is built in upfront and checks are integrated into study activities.

Qualifications:

Bachelor's degree , or equivalent, in Science related discipline7+ years experience working in a Clinical Operations environment is required.Global Clinical Operations experience is important.Experience should include 2 years of on-site monitoring and clinical research experience or education.Global Clinical Operations experience, clinical trial system experience and ICH GCPknowledge is important

BENEFITS

Medical, Dental Vision401KPaid 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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