Senior Study Manager, Epidemiology Operations

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Job Description Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types. Primary responsibilities include: Operational planning and project management of epidemiology research studies Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities Manage vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies Participate in quality control assessments and ensure integrity of study data for reports and publications Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements Collaborate extensively and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies Manage poster and publication development including: formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions Conduct literature reviews Active participation in internal process improvement initiatives and mentoring of junior study managers Educational Requirments: Bachelor's degree required / Master's degree (preferred) in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences) Five (5)+ years of work experience within clinical/observational research or equivalent experience; or PhD with 3+ years relevant career experience Required experience and skills Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders Knowledge of epidemiology and/or outcomes research Strong project management and prioritization skills Highly motivated, able to work independently and collaboratively Required Skills: Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Data Analysis, Epidemiology, Ethical Standards, ICH GCP Guidelines, Project Prioritization, Public Health, Regulatory Compliance, Regulatory Documents, Safety Management, Scientific Publications Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incen

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