Clinical Program Manager

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.

We are committed to creating a diverse and inclusive workplace environment. An environment where colleagues can fulfill their career aspirations, realize their potential, and use their unique perspectives and experiences to make a difference in a world that needs solutions to rare and serious disease.

Could you be our next Clinical Program Manager? This position is located in our King of Prussia office or any of our CSL locations. It is a Hybrid role. You will report to the Senior Program Manager.

The Clinical Program Manager (CPM) is accountable for the on-time delivery of a clinical program for the Respiratory Area.

The CPM is responsible for clinical operational planning activities and leads program/study execution. The CPM leads one or more studies and may take on additional responsibilities as dictated by project size and complexity. The CPM provides overall clinical project management, leads the study execution team (SET) and coordinates study execution at the global level. The CPM oversees program/study level outsourcing, takes preventive/corrective action(s) to address study/program level issues.

• You will manage the project management of the Respiratory program/study.
• Develop overall feasibility concept and enrollment plan with input from COMs.
• Manage study budget..
• Help with operational aspects of the protocol.
• Ensure regulatory compliance and GCP compliance.
• Responsible for oversight of TMF with periodic audits.
• Lead vendor selection and management including issue escalation.
• Collaborate with CTS team to coordinate IMP and non-IMP supplies.
• Plan, lead SET (internal) meetings and act as the CSL lead for vendor meetings.
• Ensure monitoring plan is developed and performed in collaboration with COMs.
• Ensure Clinical Operations team and external provider receive study specific training.
• Report important study performance information, including study startup metrics, enrollment, data collection /quality.
• Facilitate study close out activities through completion of Clinical Study Report
• Be a primary contact for internal groups outside of CRD (including Regulatory, Commercial Development and Project Management) for program/study specific information.
• Maintain knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.

REQUIREMENT

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area. Other degrees and certifications considered if determined by related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• 6+ years' relevant clinical research experience in the pharmaceutical industry.
• Experience overseeing global clinical trials in respiratory (pharmaceutical or research institute).
• Budget forecasting and management.
• Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.

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Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

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