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Senior Global Clinical Operations Lead (GCOL) - Seqirus -398BR
Cambridge, MA - Massachusetts, United States
Are you looking for a rewarding career in a market-leading and innovative company? Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.Our Global Clinical Operations Group is currently looking for the Senior Global Clinical Operations Lead. The role can be based in Amsterdam, Netherlands or Cambridge, MA. Position Purpose:The Senior Global Clinical Operations Lead 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 (e.g. Seasonal Influenza, Pandemic etc.).The Senior GCOL is responsible for:
The Senior GCOL acts as primary interface with the CD Therapeutic Area Scientist/MD with respect to Clinical Operations (including program timelines; budgets; and protocol development). It also will be the primary interface for key stakeholders (Regulatory/Commercial Operations/Commercial Development/Project Management/Finance) regarding operational delivery of clinical programs within a designated Therapeutic Area. The Senior GCOL is a standing member of all Core Project Teams within designated Therapeutic Areas Main Accountabilities:
- Championing the Clinical Research Program(s), keeping abreast of pertinent developments in the therapeutic area including regulatory strategies and competitor status
- Clinical operational planning activities and is accountable for leading program/study execution.
- Leading one or more studies and may take on additional responsibilities as dictated by project size and complexity.
- Providing overall clinical project management, leading the cross-functional study execution team (SET) and coordinating study execution at the global level.
- Overseeing program/study level outsourcing, taking preventive/corrective action(s) to address study/program level issues.
- Planning, management and execution of clinical programs:
- Responsible for the project management of a clinical program/study
- Create and drive study level timeline
- Develop overall feasibility concept and enrolment plan with input from Clinical Oversight Monitors (COMs)
- 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 CVM team to plan and coordinate IMP and non-IMP supplies
- Plan, lead, and facilitate internal meetings as well as act as the 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
- Consult with COMs for strategic selection of countries and sites
- Facilitate and coordinate communications with external providers
- Ensure Clinical Operations team and external providers receive study specific training
- Report key study performance information, including study start-up metrics, enrolment, data collection timeliness/quality, study/program issues
- Facilitate study close out activities through completion of Clinical Study Report
- Responsible for reviewing data and data listings
Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
- 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).
- Proven relevant clinical research experience within the pharmaceutical industry.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. Extensive knowledge in the medical / scientific / regulatory field.
- Experience in overseeing global clinical trials (pharmaceutical or research institute). 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.
- Budget forecasting and management.
- Demonstrated project management skills including simultaneous management of multiple projects. Excellent planning, time management & coordination skills.
- Demonstrated ability to lead teams and work in a fast-paced, matrix environment.
- Excellent interpersonal and decision making skills. Demonstrating drive, energy and enthusiasm to deliver the program objectives.
- Excellent written and oral communication skills.
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