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Global, biopharmaceutical company at the forefront of designing precision combinations in the pursuit of cures
Clinical Trial Manager
Location
United States
Posted
60 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Clinical Trial Manager
Arcus Biosciences
Role Description The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include: - Assuring successful conduct of clinical studies consistent with applicable regulations, guidelines, and procedures. - Supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. This position is remote or in-house, depending on prior experience, and will report to a Clinical Operations Manager. Bay Area staff will operate in a hybrid or office-based model aligned with Arcus expectations. Responsibilities - Day-to-day management of assigned operational aspects of low to medium complex clinical trials, including vendor/laboratory management and oversight of clinical sites. - Obtains and reviews all required essential documents necessary for study/site initiation. - Maintains accurate and timely sponsor/site correspondence and communication. - Prepares and presents project progress reports. - Manages and tracks patient enrollment, site performance, and monitoring metrics. - Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies. - Supports the development and review of clinical study plans, presentations, or study-related documents. - Assists in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT on related systems. - Assists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sites. - Performs in-house review of clinical data listings for completeness and accuracy and escalates issues to the Clinical Program Manager, as needed. - Works closely with data management lead to perform data cleaning activities with cross-functional team. - May lead and coordinate protocol deviation review and documentation. - Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics. - May perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures. - Reviews monitoring trip reports and tracks resolution of all action items. - Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal). - Assists with providing oversight of CROs and vendors. - Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, and assists with resolving site issues. - Assists with set-up and review of clinical TMF. - Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings, as requested. - Contributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient-facing materials, etc. - Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable. - Recommends and implements innovative ideas to increase efficiency and quality of program management activities. - Contributes to process and departmental and cross-functional improvement activities. Qualifications - Bachelor’s degree, preferably in a scientific field. - 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology. - Demonstrates core understanding of clinical trial related terminology and activities. - Thorough understanding of ICH GCP guidelines and Code of Federal Regulations. - Understanding of clinical trial processes from study start-up through study closure. - Ability to establish priorities, sense of urgency, and collaborate with the study team, cross-functional team members, and external partners/vendors. - Excellent planning and organization skills. - Self-motivated, assertive, and able to function independently and as part of a team. - Strong interpersonal and negotiation skills as well as strong verbal and written communication skills. - Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e., EDC, IRT, CTMS, eTMF, etc.). - Ability and willingness to travel 10-20% (domestic and international). Company Description
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Senior Biostatistician
MercorCincinnatus is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for full-time and long-term contingent roles. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives. Roles hired through Cincinnatus are not project-based or freelance engagements. They are structured, role-based positions that typically involve full-time or fixed-term commitments, close collaboration with a client's internal teams, and integration into standard enterprise workflows. Cincinnatus is a legal entity separate from Mercor. While opportunities may be discovered through Mercor's platform, employment, onboarding, payroll, and benefits for these roles are administered by Cincinnatus. Equal Employment Opportunity Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic. Cincinnatus is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans throughout the job application process.
Role Description - Author technical tasks to evaluate AI model performance on statistics problems. - Review and annotate tasks involving statistical charts, regression output, and distribution plots. - Produce original problem sets grounded in diagnostic figures and apply structured quality checks. - Write reference solutions and articulate reasoning step-by-step in written form. - Work independently and asynchronously with a flexible schedule to improve AI model outputs. Qualifications - Must-Have: PhD in Statistics or Biostatistics, or MS in Statistics with 3+ years applied research, data science, or teaching experience, or BS in Statistics or Math with 5+ years applied statistical analysis or data science experience. - Working fluency in at least two of: probability, inference, regression, Bayesian methods, experimental design. - Comfortable reading and interpreting statistical charts, regression output, distribution plots, and diagnostic figures. - Clear technical writing skills. Requirements - Hourly contractor. - Paid weekly via Stripe Connect. Application Process - Upload resume. - AI interview based on your resume. - Submit form. Resources & Support - For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome - For any help or support, reach out to: support@mercor.com
Biostatistician
MercorCincinnatus is an enterprise staffing company that partners with leading technology companies to source and employ highly skilled professionals for full-time and long-term contingent roles. Cincinnatus serves as the employer of record for these engagements, providing W-2 employment, payroll, benefits, and compliance, while placing employees directly within client teams to work on high-impact initiatives. Roles hired through Cincinnatus are not project-based or freelance engagements. They are structured, role-based positions that typically involve full-time or fixed-term commitments, close collaboration with a client's internal teams, and integration into standard enterprise workflows. Cincinnatus is a legal entity separate from Mercor. While opportunities may be discovered through Mercor's platform, employment, onboarding, payroll, and benefits for these roles are administered by Cincinnatus. Equal Employment Opportunity Cincinnatus is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or any other legally protected characteristic. Cincinnatus is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans throughout the job application process.
Role Description Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey. Position: Statistics Expert Type: Contract Compensation: $72–$80/hour Location: Remote Commitment: 20 hours/week Role Responsibilities - Author technical tasks to evaluate AI model performance on statistics problems. - Review and annotate tasks involving statistical charts, regression output, and distribution plots. - Produce original problem sets grounded in diagnostic figures and apply structured quality checks. - Write reference solutions and articulate reasoning step-by-step in written form. - Work independently and asynchronously with a flexible schedule to improve AI model outputs. Qualifications - Must-Have PhD in Statistics or Biostatistics, or MS in Statistics with 3+ years applied research, data science, or teaching experience, or BS in Statistics or Math with 5+ years applied statistical analysis or data science experience. - Working fluency in at least two of: probability, inference, regression, Bayesian methods, experimental design. - Comfortable reading and interpreting statistical charts, regression output, distribution plots, and diagnostic figures. - Clear technical writing skills. Requirements - Hourly contractor - Paid weekly via Stripe Connect Application Process - Upload resume - AI interview based on your resume - Submit form Resources & Support - For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome - For any help or support, reach out to: support@mercor.com - PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity.
Principal Biostatistician
Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. • Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel. • Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. • Provides independent review of project work produced by other biostatisticians in the department. • Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR. • Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required. • May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. • Implements company objectives, and creates alternative solutions to address business and operational challenges. • As biostatistics representative on project teams, interfaces with other departmental project team representatives • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications. • May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. • Identifies out of scope tasks and escalates to management. • Provides statistical programming support as needed. • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs. • Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Performs other work-related duties as assigned.
