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Manager, Clinical Operations Lead - United States
Posted on : 07 June 2017
- Partners with Clinical Operations Lead and/or Study Management Team members to support the development of operationally feasible and clear protocol concepts and final protocols. Leverages phase and operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level strategy for assigned studies and programs.
- Oversees one or more clinical studies by securing excellence in execution through guidance from primary Clinical Operations Lead and working in partnership with the CRO.
- On some studies when appropriate, the Clinical Operations Manager may work independently to oversee the execution of the study.
- May partner with Clinical Operations Management to oversee department specific initiatives or areas of control and process improvement.
- Oversees clinical aspects of their assigned study or as directed by primary Clinical Operations Lead including:
- Proactively identifies and works with CRO to resolve clinical project issues;
- Oversees clinical vendors including the partner CRO, either working independently or with the primary Clinical Operations Lead for all elements of oversight, including, but not limited to reporting, regulatory requirements, study budgets, Study Operational Strategy (SOS), quality of endpoint data, good clinical practice and patient safety.
Support operational excellence and delivery for one or more clinical studies by:
- Managing the study operational strategy (SOS) with guidance from the lead Clinical Operations Lead and Clinical Program Lead
- Providing input to operational strategy (including ancillary vendors) aligned with the program strategy and working closely with the Clinical Country Lead to set the country strategy, incorporating country input through the primary Clinical Operations Lead and study Clinical Country Lead
- Overseeing the tactical execution of the operational strategy by the partner CRO; effectively providing oversight of the CRO, including close monitoring of CRO work on established baseline plans, highlighting areas in need of focus to assure issues are raised and resolved so baselines can be achieved
- Utilizing operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of study(ies).
- Driving performance, quality, timelines and relationships through the CRO partnership model
- Ensuring clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs, and that the studies are conducted with a focus to being inspection-ready at any given time point
- Chairing/Co-chairing the Study Management Team in partnership with the CRO study Lead; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues.
- Overseeing delivery of the study to budget
Strives for effective, consistent, efficient and compliant processes by:
- Participating in best practice development in Phase planning and seeking opportunities for innovation and efficiency with the Clinical Operation Management group
- Following established procedures and SOPs; seeks ways to improve and streamline processes to support the Global Clinical Operations CRO outsourcing model; provides feedback via appropriate channels for opportunities to improve processes or set best practices (
- Embodying a culture of continual improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model.
- Being an advocate for the Clinical Operations Management group and a visible contributor and vehicle to promote interaction
- Providing input on behalf of Clinical Operations Management into process and business initiatives with the opportunity to also oversee and manage department specific areas of focus.
Approximately 5 years of clinical research, including 3+ years of project management experience with either a sponsor company or CRO, managing outsourced clinical trials within quality, timeline, and budget expectations.
B.A. or B.Sc. in a scientific discipline, advanced degree optional. Scientifically and clinically astute with very strong project management skills.
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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