Please submit your application and CV in English What Youll Do: Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead. Set goals, and timelines, provide oversight and
What youll do: Develop and lead the global study start-up and site activation strategy for assigned trials, including activation assumptions, country and site sequencing, critical path dependencies, milestone projections, and mitigation plans. Establish, maintain, and communicate
What Youll Do: Assist with the development and modification of department SOPs and work instructions Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians Develop study bids and changes in scope for Biostatistics
What Youll Do: Handle incoming and outgoing calls by using a Clinical research database to recruit, screen, determine eligibility, schedule, and follow-up with potential study subjects and responds to inquiries relating to advertising and referrals to
Coordinate the conduct of Phase I through Phase IV clinical research studies in accordance with Good Clinical Practices (GCPs), International Harmonization Guideline and Standard Operating Procedures (SOPs) beginning with pre-study planning through successful completion of all
What Youll Do: Assist/Advise project teams on all regulatory requirements for clinical studies Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings Review and adapt study specific
Job Purpose The Medical Director will be responsible for growing and leading a therapeutic portfolio through their medical and clinical development expertise and by providing medical and safety monitoring of awarded clinical trials. The Medical Director
Please submit your application in English What Youll Do: Support of Regulatory Affairs Study Start-Up (RASSU) department: Assist/Advise project teams on all regulatory requirements for clinical studies Perform compliance assessments according to country requirements and document
ESSENTIAL FUNCTIONS Maintain advanced knowledge of ICH GCP compliance and regulatory expectations across multiple regions Provide regulatory compliance guidance and quality improvement consult to internal and external customers, ensuring global alignment Conduct protocol risk reviews and
What Youll Do: Assist Auditors with Sponsor audits and regulatory authority inspections to facilitate the auditing & inspection process Manage and initiate regional testing for the annual update of the Business Continuity Plan Assist in tracking
Please submit your application in English What Youll Do: Support of Regulatory Affairs Study Start-Up (RASSU) department: Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level
What Youll Do: Assist in organizing, composing, and producing professional letters, summaries, reports, minutes, etc, using Microsoft Office software including Word, Access, and Excel Proofread documents ensuring grammar, spelling, and punctuation are correct Assist in developing
What Youll Do: Serve as main CTI contact for assigned study sites Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given
About CTI CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research
Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation
Please submit your application in English What Youll Do: Initiate site contact and follow-up as necessary to turn study confidentiality agreements (CDA) and study clinical trial agreement (CTA) drafts Administer contract language to ensure it remains
What Youll Do: Support the administration and maintenance of financial systems, including Sage Intacct, Concur, and Certinia (FinancialForce) Assist with maintaining resource records, user access, roles, and permissions in compliance with internal controls and audit requirements.
CTI Clinical Trial and Consulting Services is seeking a Senior Biostatistician with extensive clinical trial experience. You will lead statistical activities across studies, act as the primary statistician for internal and external teams, and contribute to