Sr. Clinical Program Manager
The Senior Clinical Program Manager (Senior CPM) is accountable for the development of the operational strategy for a clinical program as well as the on-time delivery of a clinical program and remaining within budget for an assigned Therapeutic Area.
The Senior Clinical Program Manager is responsible for clinical operational planning activities and is accountable for leading program/study execution. The Senior CPM manages two or more studies/or products and may take on additional responsibilities as defined by the Therapeutic Area Lead as dictated by project size and complexity with minimal oversight. The Senior CPM leads overall clinical project management, leads, supports, and advises the cross-functional study execution team (SET) and coordinates study execution at the global level. The Senior CPM oversees program/study level outsourcing, takes preventive/corrective action(s) to address study/program level issues. The Senior CPM will manage/mentor Clinical Study Managers (CSMs) and Clinical Trial Assistants (CTAs).
Main Responsibilities and Accountabilities:
1. Plan, manage and execute clinical programs
• Responsible for the project management of a clinical program/study
• Participate in program resourcing discussions
• Create and drive study level timeline
• Develop overall feasibility concept and enrollment plan with input from site management team
• Develop and manage study budget
• Provide input on operational aspects of the protocol
• Ensure regulatory compliance and GCP compliance
• Responsible for oversight of TMF with periodic audits
• Responsible for leading vendor selection and management including issue escalation
• Develop and implement Study Management plan and all associated documents (i.e. vendor oversight plan)
• Collaborate with CTS team to plan and coordinate IMP and non-IMP supplies
• Plan, lead, and facilitate SET (internal) meetings as well as act as the CSL lead for vendor meetings
• Ensure monitoring plan is developed and consistently executed in collaboration with COMs
• Develop proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
• Consults with site management team for strategic selection of countries and sites
• Facilitate and coordinate communications with external provider
• Ensure Clinical Operations team and external provider receive study specific training
• Report key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality
• Facilitate study close out activities through completion of Clinical Study Report
2. Provide operational input into the overall program strategy.
3. Act as the primary point of contact for internal groups outside of CRD (including Regulatory, Commercial Development and Project Management) for program/study specific information.
4. Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.
5. Ensure standard processes, tools and procedures are used consistently for study execution.
Position Qualifications and Experience Requirements:
At minimum, bachelor degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• As a guide, a minimum of 10+ years’ project management of Phase I-III clinical research experience within the pharmaceutical industry.
• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
• Experience in overseeing global clinical trials (pharmaceutical or research institute).
• Budget forecasting and management.
• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
Desired Attributes - The following are considered desirable:
• Postgraduate qualifications.
• Experience in scientific/medical research.
• Specialist knowledge e.g. immunology, coagulation disorders, pulmonology, virology, oncology and cardiology.
• Demonstrated proficiency in advanced MS Project.
• Demonstrated ability to lead teams and work in a fast-paced team environment.
• Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment
• Demonstrated successfully the ability to mentor and coach others through peer to peer interactions
• Excellent interpersonal and decision making skills. Demonstrates innovation. Possesses drive, energy and enthusiasm to deliver the program objectives.
• Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
• Ability to plan, and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
• Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge.
• Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
• Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs.
• Excellent written and oral communication skills.
• Maintains computer literacy in appropriate software.
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership
in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.
CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business. CSLB18MAR13
The Global Diversity Principle/EEO Statement below must be included in all postings. Please be sure to include it when copying your position description into Taleo. Minimum requirements and flexible working hours will be considered as related to our EEO policy.
CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.
CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.
• Internal contacts include VPs, Senior Directors, Directors, Associate Directors, Managers, SET members and research related departments (e.g. regulatory, therapeutic areas). Other internal contacts include manufacturing, project management, Clinical Safety, CQA, Business Development, Commercial Development, and Commercial Operations.
• External contacts include MD investigators, scientists, clinical staff, contract research organizations, and outside consultants.
• Domestic and international travel required. Amount dependent upon project needs
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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.
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As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
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