The O'Connor Group

Senior Clinical Trial Manager

The O'Connor Group

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • The Sr. CTM is the lead operational contact for the study and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs.
  • Responsible for all operational aspects and progress of assigned clinical trial from a study planning activity to study execution including ongoing tracking all applicable performance metrics and quality indicators for milestone deliverables
  • Provide expertise and operational input into protocol synopsis, final protocol and other study related documents
  • Participate in country and site feasibility/selection process
  • Create and maintain timelines to meet the needs of the assigned clinical study(ies)
  • Ensure new team members and vendors are onboarded
  • Lead the development of the operational strategy in preparation for review; focus on ensuring accurate assumptions are applied and risk management plans are in place
  • Provide guidance to CRO/vendor to ensure study issues are addressed and resolved
  • Work to ensure that budgets, enrollment, and gaiting are maintained and accurate; communicate study status, cost and issues to Project Leader(s); serve as escalation point for vendors or other CROs
  • Support CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
  • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
  • Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring
  • Review and endorsement of relevant study plans, as applicable
  • Study team meeting management and attendance; regular review of meeting agendas and minutes
  • Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study
  • Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies
  • In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR
  • Ensure studies are "inspection ready" at all time; may be involved in regulatory inspections by preparing for and attending the inspections
  • Represent Clinical Operations Manager role in functional projects or working groups
  • Help with onboarding and mentoring of new Clinical Operations Team members
  • Participates in the development, review, and implementation of departmental SOPs, initiatives and processes
  • Reviews/approves vendor invoices for all clinical trial vendors including investigative sites

Requirements

  • BA/BS
  • 6 or more years of clinical research experience in a biotech/pharmaceutical company or clinical research organization (CRO), with a focus on clinical operations.
  • Experience with the following:
  • o Developing and writing study protocols, study procedure manuals, informed consent forms, clinical study reports and other study plans/documents
  • o Leading outsourced studies across all functional areas (preclinical, stats, data management, and medical writing)
  • o Vendor oversight including operations and budget
  • Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead to obtaining results
  • Willingness to travel as needed, up to 30% including overnight and international travel
  • Strong GCP and ICH guideline knowledge base; ability to multi-task; ability to manage a team of clinical research professionals working on a clinical trial program; strong verbal and written communication skills; flexibility
Benefits
  • This job operates in a professional office environment
  • This role routinely uses standard office equipment such as computers, phones and photocopiers
  • This position is required to work occasional nights and weekends to meet company demands
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchstudy protocol developmentclinical study report writingvendor oversightbudget managementrisk managementdata managementGCP knowledgeICH guidelines knowledgeperformance metrics tracking
Soft Skills
leadershipcommunicationindependent judgmentmulti-taskingteam managementflexibilitystrategic thinkingproblem-solvingmentoringorganizational skills