The Global Clinical Program Manager (GCPM) is accountable for the development of the operational strategy for a clinical program as well as ensuring its execution in accordance with the agreed program timelines and budget and in good quality (as highlighted in ICH-GCP, SOPs and local regulations). The GCPM is responsible for clinical operational planning activities including the setting of baseline study timelines and supporting the development of study specifications for all studies within the assigned program(s) to ensure accurate budgeting. The GCPM is accountable for program/ study level outsourcing and clinical operational oversight. The GCPM may lead or support study execution, takes preventive/corrective action(s) to address study/program level issues and supports and advises the study execution team (SET), Clinical Development Team (CDT) and Core Program Team (CPT) as appropriate. The GCPM is responsible for timely reporting of study progress, study status and escalations of issues and risks to the Head Study Management or Head Clinical Development Operations. The GCPM will manage/mentor Study Management team members such as Global Clinical Operations Leads (GCOLs).
- Responsible for planning, managing and executing clinical study / program(s) in accordance with the agreed timelines, budget and quality (following guidelines, SOPs and ICH-GCP). Activities include but are not limited to
- Provides strategic input and operational expertise to Core Program Team (CPT), Clinical Development Team (CDT) and Study Execution Team (SET) during clinical operational planning, study execution and study closure for a study/ studies within assigned program(s)
- Set baseline study timelines and support the development of study specifications for all studies within the assigned program(s) to ensure accurate budgeting by working closely with the Clinical Development Program Director and Business Operations.
- Provide input on operational design and scientific needs, build budgets, timelines and risk mitigation strategies and lead study planning activities until the study/budget is endorsed at Portfolio Governance Committee and Global Clinical Operations Lead (GCOL) assigned.
- Responsible for initiating vendor selection for a clinical study and preparing the RFP package and oversee program/ study outsourcing.
- Establish strong interaction with R&D Partners
- Align with CPT and CDT on risk and issue management and mitigation strategy
- Act as primary interface with the Clinical Development Program Director with respect to Clinical Operations (including program timelines; budgets; and protocol development)
- Provide robust strategic operational oversight for all studies within assigned program(s)
- Review (FDA/EMA) regulatory interactions
- Champion the Clinical Program(s), keeping abreast of pertinent developments in the therapeutic area including regulatory strategies and competitor status
- Ensure operational clinical program oversight including budget, quality and timelines and align on business goals and program objectives; consistency across trials and leverage synergies and innovative approaches
- Ensure standard processes, tools and procedures are used consistently across studies.
- Report key study performance information and metrics, including study start up metrics, enrollment, data collection timelines, quality measures.
- Provide leadership to Study Management team members during the different phases of a study Support with issue resolution, non-responsive team members, lack of team engagement and conflicting priorities Available for questions, guidance or direction Line manage Study Management team members such as associate or (Sr.) Global Clinical Operations Leads (GCOLs) and Clinical Trial Assistants (CTAs), with responsibility for their development, coaching and mentoring. Foster a leadership culture which attracts, develops and retains high calibre individuals with expertise in Clinical Operations and committed to providing valuable and creative input to Seqirus projects to achieve or exceed company goals
- Ensure alignment on business goals and program objectives; consistency between studies and across programs and leveraging synergies and innovative approaches - Review of KPIs - Leverage expertise or innovations across trial teams/CROs - Ensure consistent protocol language, study plans, timelines etc. - Support the development of new SOPs, guidelines etc and/ or participate in working groups about new processes
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory consideration
- Support audits/inspections and resolution of findings, including vendor or system audit
Qualifications, skills, and experience: -
- A degree in Biological Science, Allied Medical discipline or Pharmacy; preferably with a Master’s or PhD, or complementary experience in the pharmaceutical/ biotechnology industry.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process
- Experience in overseeing global clinical trials
- Experience in budget forecasting and management.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
- Postgraduate qualifications. - Specialist knowledge e.g., influenza, vaccines, pandemic.
- Effective delivery of objectives in a complex matrix environment
- Ability to deal with rapid change
- Excellent verbal & written communication skills in a cross functional environment
- Excellent project management skills
- Proactively owns and drives assigned tasks to completion –
- Proactively develops solutions and maximises opportunities ahead of time
- Strong negotiation skills with internal and external stakeholders
- Extensive and proactive commercial awareness with evidenced application to regulatory strategies - Excellent customer focus with demonstrated management of customer expectations and anticipating customer needs - Demonstrated ability to take measured risks with overall positive outcome for the business
- Excellent presentation skills
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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