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Manager, Clinical Operations

New Jersey All, NJ

Post Date: 08/17/2017 Job ID: JN -082017-19825 Industry: 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:
Quality
  • 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
Timelines
  • 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
Budget
  • 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
Planning/Leading:
  • 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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