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Senior Clinical Trials Manager

  • Horsham, PA
  • Direct Hire
  • Job ID: BN38-2689686

$1 to $2 Per Year

 

The Sr. CTM is responsible for the execution of clinical trials and will review, monitor, and ensure adherence to protocols.  The Sr. CTM will:

  • Participate in the design & execution of clinical trials, development of critical clinical documents & oversee operational implementation
  • Independently manage and communicate to management overall clinical operations plan for clinical trials including internal and external timelines, resources, costs, and critical deliverables
  • Forecast trial resource needs (external costs); accountable for trial level clinical operations budget, management & tracking of trial budget in conjunction with CRO and Clin Ops leadership; develops and provides monthly accruals and forecasting reports and participate in budget review meetings
  • Collaborate with other functional groups including Data Management, Pharmacovigilance, and others to ensure precise review of the clinical trial data
  • Participate in ongoing blinded data review & review of Tables, Listings, Figures (TLFs) prior to database lock
  • Communicate key issues and mitigations to relevant cross-functional stakeholders
  • Assist in the development of departmental Standard Operating Procedures (SOPs) and other documents to support the setup and organization of the Clinical Operations department
  • Primary point of contact for CRO and assigned vendor(s), manage CROs & 3rd-party vendors to ensure successful clinical trial implementation, execution & adherence to established timelines and budgets for assigned protocols &/or regions.
  • In conjunction with the CRO, tracks study status, timelines, enrollment, regulatory documentation, and site start-up activities for assigned clinical trials
  • Assist in review of CRO documentation to support clinical site approvals ensuring ability to meet protocol requirements, start-up timelines & enrollment projections
  • Review and approve regulatory document packages for Investigational New Drug (IND) submission & drug release as well as review and approve site budgets and contracts
  • Perform daily review of CRO & 3rd-party vendors data including but not limited to Interactive Response Technology (IRT), central electrocardiogram (ECG), & electronic data capture (EDC) online activities & promptly address issues with CRO, vendors, and Clin Ops management
  • Review CRO and vendor invoices for accuracy & ensures charges are appropriate, collaborate with finance to provide input into financial reporting & projections
  • Review and approval of all CRO and 3rd party vendor study plans, guidance documents and specification documents
  • Review CRO monitoring reports ensuring timely CRO follow-up of outstanding items & report completion
  • Effectively influences external groups to meet defined program/project targets
  • Familiar with global regulatory and compliance requirements for clinical research including code of federal regulations (CFR), electronic common technical document (eCTD) and international conference on harmonization (ICH) good clinical practices (GCP) guidelines
  • Proficiency in Microsoft (MS) Office software including Word, Excel, PowerPoint, Project
  • Available for travel to company offices, sites, vendors, and meetings
  • Minimum of 8 years experience in clinical trials manager position (and at least 5 years a lead manager for studies)
  • MUST have experience in large Global trials and late phases- please send note or cover letter referring to this experience with your resume
  • Other duties as assigned
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