Clinical Program Data Manager - United States
- The Data Management Team provides program and project oversight of outsourced clinical trials and is part of the Global Biometrics department, which consists of Data Management, Biostatistics and Statistical Programming.
- The Program Data and Analytics Lead ensures consistent application of Clinical Data Management operational decisions, facilitates development of program data standards and process within a program or group of studies, and is recognized as an operational specialist in clinical data flow and study execution by all functions across Global Development.
- Partners with key program and study team members to facilitate implementation of a robust and clear data strategy plan for studies within assigned program.
- Uses program, phase, TA and operational knowledge to establish study level operational plans and works with DM leads at CROs and other vendors to ensure timely execution.
- Develops program/study level quality plans to ensure alignment of study operational plans with program goals.
- Develops program timeline and monitors data deliverables for all studies within assigned program in collaboration with cross functional team members and vendors
- Develops/Interprets and applies data strategy, verifies consistency and usage of data standards
- Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data
- Develops data integrity, risk mitigation and action plans and oversees execution when appropriate
- Serves as a contact representing DM within Biometrics and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (Biometrics functions, GCO, Regulatory Affairs, Clinical Development Team) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
- Serves as Subject Matter Expert alongside Biometrics counterparts for data, reporting, and analysis process definition, improvement, and innovation as needed
- Develops, maintains and presents Program Overview to educate team members and vendors
- Regularly provides portfolio status updates to leadership
- Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed
- Support study-level audit and inspection readiness activities as needed
- Serve as project manager on special projects and initiatives; partners with Statistical Programming, VM and Quality depending on type of project
- 10+ years relevant work experience with a focus on data management
- Deep understanding of drug development and biopharmaceutical industry required
- Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
- High attention to detail including proven ability to manage multiple, competing priorities
- Experience overseeing outsourced clinical trials work
- Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
- Deep knowledge of clinical data management outsourcing with full-service, global CROs and FSPs
- Expertise in clinical program indications, end points, dataflow, data integrity, standards, and data quality
- Demonstrated ability to influence without authority
- Excellent written and oral communication skills
Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
- 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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