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The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
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Core Responsibilities - Accounts Receivable/Payable: Regularly review contracts/budgets, create/maintain study calendars and manually gather data from MGH Cardiology study teamsEnsure timely clinical trials invoicing to industry sponsors which matches protocol driven procedures with patient accruals/visits to ensure appropriate invoicing and reimbursement.
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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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Supervise all senior staff including the Director of Residential Services, Director of Family Services, Director of Day Services, Director of Human Resources, maintenance and quality assurance.
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Reporting directly to the Director, Business Applications, this position will be responsible for leading data strategy, contributing to enterprise data lake & analytics platforms using Snowflake, Fivetran and DBT technologies and drive standardization, operational excellence across the organization.
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Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office.
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Key responsibilities for Associate Director of Biostatistics are: Driving the statistical strategy of the designated projects taking into consideration the impact across Development. This position will report to the Executive Director of Biostatistics and Programming.
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Veralto is looking for a Director of Strategic Development to contribute to the corporate strategic direction for the new ~$5B enterprise. The Director of Strategic Development will help define strategic direction and inorganic priorities for Veralto.
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Chef Instructors are responsible for supervising students as they check in the day’s ingredients, stock pantry items, pack ingredient box at end of class, break down and cleanup of kitchens, trash removal, kitchen sanitation, and compost removal, among other duties as assigned by Director of Education.
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Dir/ Senior Director, Clinical Research Scientist 2020393. Proficient knowledge of drug development process, study design, response assessment criteria, statistics, and clinical operations.
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Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
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Utilize housing software (currently transitioning from The Housing Director to StarRez) to manage room assignments, occupancy reports, and student information. The Housing Operations Specialist will report directly to the Assistant Director of Housing Operations, with a dotted line to the Associate Director of Housing Operations for summer housing responsibilities.
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Author the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-author, assist and support the development of publications, abstracts, and presentations.
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Promote diversity, including with respect to experience and thought leadershipApply the PPI systems and business processes to drive alignment across functions and disciplines in support of the customerQualificationsEducationUndergraduate degree in a relevant course of study.
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The Study Implementation Manager is the main interface between our customers and our internal study deployment teams and combines project management, technical and business analysis skills into a key delivery role that supports our goals and ambition to become the leading health-tech provider for clinical studies globally.
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study director jobs Company: Genoskin in Burlington, MA
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