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Clinical Trial Manager I-II

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Spain

Posted

80 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Trial Manager I-II

Syneos Health

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Demonstrates diligence in protecting the confidentiality of each subject/patient. • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • Assesses site processes for the Clinical Monitoring/Site Management Plan (CMP/SMP). • Conducts Source Document Review of appropriate site source documents and medical records. • Verifies required clinical data entered in the case report form (CRF) is accurate and complete. • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture. • Verifies site compliance with electronic data capture requirements. • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. • Verifies issues or risks associated with blinded or randomized information related to IP. • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. • Supports subject/patient recruitment, retention and awareness strategies. • Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. • Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. • May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Job Requirements

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
  • Previous experience as CTM mandatory.
  • At least 5-7 years of relevant experience in clinical research (SSU to close)
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 50% on a regular basis.

Benefits

  • We are passionate about developing our people, through career development and progression
  • supportive and engaged line management
  • technical and therapeutic area training
  • peer recognition and total rewards program
  • We are committed to building an inclusive culture – where you can authentically be yourself.

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