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Senior Clinical Trial Analyst

United States, United States · Biotech/Pharmaceutical
JOB TITLE:           Senior Clinical Trial Analyst
REPORTS TO:      Vice President of Operations and Product
STRUCTURE:       Full Time, Salaried
LOCATION:           Remote
 
Medstreaming/M2S is a leading Healthcare Data company focused on using Real World Evidence and data science to help healthcare clients find better solutions for their patients. We harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward. We know that meaningful results require not only the right approach but also the right people. We invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare evidence forward and ultimately improve human health outcomes.

Responsibilities
  • Perform hands-on data analysis in support of project planning and operations by combining data from disparate sources.
  • Present and explain data reports in an accessible and understandable way to internal and external stakeholders, including industry partners, steering committees, medical groups, study team members, management, and study participants.
  • Coordinate development of the study, analysis plans, and registry revision synchronization with project/trial requirements and objectives from a data perspective.
  • Monitor data collected through clinical trials to ensure it remains sound, relevant, accurate, and reliable.
  • Interact with internal and external groups (Medical Societies, working groups, steering committees, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines, operational and clinical objectives per Good Clinical Practices (GCP) and relevant national and international requirements.
  • Support the data requirements of Trial Managers in the execution of assigned clinical trials, post-approval studies, and other data collection/reporting projects through data analysis, report design/development, and ad-hoc data requests.
  • Assist Trial Managers with budgets and site reimbursement, review and validate project operational/financial reports and data. 
  • Participate in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies.
  • Maintain professional clinical and technical knowledge by staying current on pharmaceutical, FDA, and medical device industry research and developments as appropriate and functioning as a resource to colleagues on appropriate topics.
  • Create reports and lead data presentations/discussions at internal and external trial/study meetings.
  • Attend Medical Society regional group and annual meetings as needed.
  • Work in conjunction with product and software development and quality teams.
  • Works cross-functionally with the Clinical Trials team, Informatics team, Data Services, Registry Operations, and external clients.
  • Serves as a subject matter expert on data-oriented topics related to clinical studies, including but not limited to developing training and standard processes, training/support of study site personnel, reviewing registry data, and contributing to presentations at external industry meetings.
  • Generates and provides feedback on draft protocols, analysis plans, study reports, and other clinical study documents as required.
  • Assure that studies are carried out according to the study protocol, SOPs, regulations, and study-specific manuals and procedures.
  • Performs duties in compliance with SOPs and FCP guidelines per regulatory, legal, and ethical standards.
  • Tracks and reports on the progress of site activation, patient enrollment, and patient visit/data compliance.
  • Develops solid professional relationships with industry partners, site study staff, and study participants.
  • Ensures the timely delivery of high-quality data reports to industry partners, including identifying issues through ongoing data review, defining and directing resolution measures, ensuring study objectives are met, reporting progress, and escalating relevant issues to management.
Required Qualifications
  • Bachelor's degree from a four-year university or college is required; a degree in a scientific or health-related field is preferred.
  • Excellent written and oral communication skills.
  • 3+ years’ work experience in data collection and data management and extensive hands-on experience with data analysis and visualization
  • 3+ years’ work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
  • Working knowledge of relational databases and data warehouse technologies and at least one EDC system or registry platform
  • Knowledge of SQL, Oracle APEX, and data analysis tools (SAS, SPSS, Tableau, Microsoft Power BI, or equivalent).
  • The ability to manage multiple priorities across complex data-heavy projects.
  • Familiarity with the lifecycle of clinical trials or post-approval studies: from protocol development and feasibility, ongoing trial and data management through study close-out and reporting.
  • Excellent knowledge of databases, Microsoft Office, and Google Workplace (G-Suite) tools required.
  • Understanding clinical software development principles, theories, and concepts and knowledge of pharmaceutical/medical device industry practices, standards, and processes, including GCP, is preferred.
  • The ability to communicate in medical, scientific data-related terms with vendors, peers, customers, both technical and non-technical alike, is essential.
  • Ability to read, analyze and interpret professional journals, technical procedures, and government regulations.
  • The ability to write reports, business correspondence, and procedure manuals.
  • The ability to effectively present information and respond to questions from groups of managers, sites, medical societies, steering committees, working groups, etc.
  • The ability to solve problems and deal with various concrete variables in situations where only limited standardization exists.
  • Must have demonstrated ability to work independently and as part of a team.
  • The ability to manage time, multi-task, and prioritize to complete deliverables on schedule.
  • Experience with vascular and neurovascular imaging a plus.
  • Experience with post-approval studies and clinical registries a plus.
  • Experience with the Society for Vascular Surgery VQI or SNIS NVQI Registries a plus.
 
We recognize that talented people are attracted to companies that provide competitive pay, a comprehensive benefits package, and outstanding advancement opportunities. For this reason, we offer a comprehensive benefits plan that includes the following:
 
  • 401K and Company match
  • Medical coverage
  • Dental coverage
  • Vision Coverage
  • Paid time off
  • Flexible spending accounts
  • Employee life insurance
  • Disability insurance
 
Medstreaming is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation or identity, national origin, disability status, or protected veteran status. We provide reasonable accommodations to applicants and employees with disabilities.

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