ClinChoice

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🔥 Senior Data Manager_Remote @ US/CAN (Contract role)

Posted 2024-11-22

📍 US, CAN

🧭 Full-Time

🔍 Clinical research organization (CRO)

Minimum BA/BS in scientific or health-related field.
Minimum of 5 - 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO.
Oncology or auto-immune experience required.
Comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, etc.).
Proficient with Medidata RAVE and familiarity with Medidata Suite products preferred.
Excellent communication skills (verbal and writing).
Ability to multi-task and take on new responsibilities in a fast-paced, small company setting.
Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.).
Strong organizational skills and ability to prioritize tasks.
Proven ability to work independently and in a team setting.

Act as Lead Data Manager across one or more clinical studies and lead all aspects of data management activities.
Provide expertise and oversight of all clinical database activities from design/start-up to closeout.
Review protocols for appropriate data capture including electronic (eCRF) design.
Support CRF design, review, and validation of the clinical database.
Provide oversight of database set-up/migrations/upgrades including coordinating User Acceptance Testing.
Conduct oversight of data management vendors and ongoing review of quality and performance metrics.
Generate, resolve, and track data queries to ensure clinical data integrity.
Facilitate and participate in data cleaning activities.
Generate/review/approve various study documents related to data management.
Review CRF metrics reports against project data deliverables.
Maintain internal data management timelines and metrics, ensuring inspection readiness.
Identify potential data management issues/risks and communicate within the study team.
Participate in process improvement activities.

LeadershipProject ManagementData AnalysisCross-functional Team LeadershipData analysisCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelProblem SolvingMicrosoft OfficeAttention to detailOrganizational skillsTime ManagementWritten communicationMultitaskingDocumentationMicrosoft Office Suite

Posted 2024-11-22

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🔥 Client Success Manager

Posted 2024-11-11

📍 United States

🧭 Full-Time

🔍 Life Sciences, Pharmaceutical, Medical Devices, Biotech

Bachelor’s degree in a technical or business field; advanced degree preferred (e.g., MBA, MS, PhD).
5+ years of applicable business, sales, or consulting experience.
2-3 years leading major programs for Global 1000 companies; consulting firm experience preferred.
Clinical, safety, or regulatory domain knowledge to understand client marketplace and business drivers.
Strong executive presentation and communication skills.

Cultivate and lead relationships with existing clients in pharmaceutical, medical devices, and biotech sectors.
Advise clients on strategic issues for long-term partnership.
Support sales activities and business expansion by engaging with clients.
Lead the coordination of RFP responses and client presentations.

LeadershipProject ManagementBusiness DevelopmentData AnalysisProduct ManagementProject CoordinationCross-functional Team LeadershipStrategyBusiness developmentData analysisGoCommunication SkillsAnalytical SkillsCollaborationProblem SolvingNegotiationAttention to detailOrganizational skillsPresentation skillsTime ManagementWritten communication

Posted 2024-11-11

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🔥 Senior Statistician Consultant-R&I (Respiratory & Immunology) REMOTE@UK/EU_Contract role

Posted 2024-11-09

📍 UK, EU

🧭 Contract

🔍 Clinical development, Pharmaceutical, Biotechnology

MS or PhD in Statistics, Biostatistics or related field.
Strong SAS skills are required.
Experience required in Respiratory & Immunology TA (Asthma Study).
Strong oral and written communication skills.
Demonstrated understanding of statistics, drug development process, and relevant FDA regulations.
Experience with clinical trials and interaction with Regulatory Agencies, especially FDA.

Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight and assure quality and consistency with project requirements.
Ensure data for statistical analyses are complete, accurate, and consistent.
Manage statistical analysis plans and the accuracy and timeliness of statistical input into reports.
Demonstrate understanding of statistical concepts, correct flaws in reasoning and interpretation.
Mentor peers in statistical methodology and train less experienced statisticians.

LeadershipData AnalysisSAS EGData analysisCommunication SkillsAnalytical SkillsCollaborationMicrosoft ExcelMentoring

Posted 2024-11-09

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🔥 Lead/Principal Statistical Programmer Consultant(Hematology, Clinical Trials) REMOTE@CANADA

Posted 2024-11-07

📍 Canada

🧭 Contract

🔍 Clinical Trials, Hematology

Bachelor’s degree in computer science, statistics, or related scientific disciplines with 8 years of clinical programming experience.
Master’s degree in CS, statistics, or related disciplines with 7 years of clinical programming experience.
Oncology/Hematology therapeutic area experience required.
ISS & ISE experience is required.
Working knowledge of ICH and Good Clinical Practices.
Strong communication and coordination skills.

Lead and support all programming activities per project strategies.
Develop Tables, Figures, Listings (TFLs) deliverables from SAS programs.
Customize outputs and graphics based on delivery specifications.
Support the programming deliveries of clinical studies.
Communicate and escalate risks associated with assigned studies.

LeadershipData AnalysisSAS EGData analysisCommunication SkillsAnalytical SkillsMicrosoft Excel

Posted 2024-11-07

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🔥 Lead/Principal Statistical Programmer Consultant(Hematology-Clinical Trials) REMOTE

Posted 2024-11-07

📍 United States

🧭 Contract

🔍 Clinical research and development

Bachelor’s degree in computer science, statistics, or related discipline with 6 years of clinical programming experience, or a Master’s degree with 8 years of experience.
Experience in Oncology/Hematology TA is required.
Experience with ISS & ISE is required.
Knowledge of ICH and Good Clinical Practices, clinical research, and regulatory requirements is necessary.
Understanding of the clinical drug development process.
Strong communication and coordination skills are essential.
Current knowledge of technical and regulatory requirements relevant for the role.
Ability to manage concurrent activities within a project.

Lead and support all programming activities per project strategies.
Develop Tables, Figures, Listings (TFLs) from existing SAS programs.
Customize outputs and graphics according to delivery specifications.
Support Programming deliveries of clinical studies or projects.
Contribute to best practices for quality and efficiency.
Ensure compliance with standards and automation.
Plan and support team activities and tasks.
Communicate and escalate risks within assigned studies.

LeadershipSQLData AnalysisSAS EGData analysisCommunication SkillsAnalytical SkillsMentoringAttention to detailWritten communication

Posted 2024-11-07

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