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Manager, Clinical Operations

New Jersey All, NJ

Post Date: 08/17/2017 Job ID: JN -082017-19825 Job Type: Clinical Project Management - Clinical
  • Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations methodologies, organizational, project management and leadership capabilities
  • Works to ensure adherence to a standardized approach to project management
  • Manages clinical trials projects through leadership of and delegation to a cross-functional study execution team (CST); acts as a mentor/coach to junior staff
  • Ensures successful clinical trial planning, execution and delivery within specified quality, time and cost parameters
  • As a result of a strong understanding of methodologies and approaches, ensures alignment of clinical project goals with Clinical Operations program objectives
Responsibilities Include:
  • Develops a quality control plan for trial master files and then ensures those TMFs are created, maintained, monitored, and closed out on a timely basis
  • Ensures site monitoring reports are accurate and thorough and that metrics are being adhered to
  • Actively participates in the development of department initiatives, including acting as lead on the development /definition of certain SOPs and processes
  • Ensures that an overarching trial cross-functional quality plan is in place
  • Develops project management skills in self to increase consistency and drive Clinical Operations performance
  • Responsible for managing creation, maintenance and close out of TMF activities e.g. manages Central Lab and ancillary vendors such as IVRS selection, set-up, conduct, and close-out for studies
  • Adheres to Clinical Operations processes and SOPs
  • Oversees and manages vendors (CRO) to ensure that clinical trials are getting the necessary resources and attention the vendor has committed to ensure trial deliverables and performance goals are met
  • Escalation to Program lead when necessary
  • Oversees the development of and adherence to clinical trial project timelines, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs; works with RA to establish timeframes and ensure clarity of documentation required; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
  • Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, and data collection) with other functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Provides regular timely communications to Supply Operations regarding patient enrollment information at sites to support the supply of drug products to patients
  • Supports timely and efficient database lock by ensuring monitoring plans are in place and by participating in data review / reconciliation efforts
  • Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
  • Oversees the administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
  • Adheres to clinical trial budgeting process and provides input on process optimization landscape
  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close to ensure both internal and external deliverables are on time and on budget
  • Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
  • Proactively identifies, negotiates and brokers solutions to individual clinical study issues
  • Delegates and oversees the management of certain aspects of project management to CTA and Senior CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters
Job Requirements
  • BA/BS with 5-10+ years of progressive experience in clinical operations preferably within the biotech, pharmaceutical, CRO, industry plus Oncology experience
  • Demonstrates ability to provide input into clinical protocol development
  • Demonstrates ability to manage and execute clinical studies
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
  • Experience of managing/overseeing CROs/vendors
  • Very strong verbal, written and presentation skills are required
  • Experience of leading of a matrixed cross-functional team

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