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Senior Manager, Clinical Operations

Reference Number: 3199
Location: Southern New England

Our client is an emerging pharmaceutical company.  They have asked us to assist them in their search for a Senior Manager, Clinical Operations.

Major tasks and responsibilities will include:

  • Builds, manages, and maintains budgets, contracts and timelines for a given clinical trial.
  • Prepares content for training materials and coordinates training on study procedures.
  • In collaboration with medical director for study, creates and leads the development of study plans and study specific working practices.
  • Establishes study team contacts, roles, responsibilities, and objectives.
  • Develops, manages, and maintains relationships with external partners.
  • Develops study execution plans and risk management plans.
  • Facilitates effective communication between study sites and study team members to ensure ongoing successful execution.
  • Leads, trains and mentors CRA’s/CTAs and CTMs.
  • Contributes to ongoing process initiatives.
  • Acts as point of escalation for study related issues.
  • Serves as lead project manager for the functional area in managing study planning and execution.
  • Oversees study planning and timelines to ensure alignment with overall clinical development plan.
  • Works with management to determine resourcing needs.
  • Leads the development of study documents including protocols, informed consent forms, and study manuals.
  • Meets timelines of investigational product manufacturing, labeling, release and management.
  • Oversees setup and management of CTMS and the TMF.
  • Leads country selection and feasibility studies.
  • Identifies prospective investigative sites and participates in final investigative site selection.
  • Liaises with vendors to ensure quality site selection.
  • Oversees negotiation of financial terms of individual site budgets.
  • Monitors GCP/ICH site level compliance.
  • Participates in preparation of RFP, assumptions and SOW.
  • Contributes and reviews specs for affiliated vendors.
  • Oversees all aspects of vendor management.
  • Provides input,  reviews,  and approves vendor study specifications.
  • Serves as point of escalation for vendor related issues as they arise.
  • Reviews and approves/scrutinizes specified costs on vendor invoices against contract or appoints Manager, CTM.
  • Participates in design and approval of various project and communication plan.
  • Prepares detailed study timeline.
  • Reviews eCRF specs (EDC) and reviews CRF completion guidelines.
  • Designs, reviews and approves study tools (for investigative site use).
  • Facilitates development,  reviews, and approves Data Management documents (CRO and in-house studies).
  • Input Clinical Database, Safety and CSR Reports.
  • In collaboration with Data Management, plays a lead role in the development of procedures and tools for data collection.
  • Oversees collection of data to ensure compliance with protocol and clinical research project objectives, FDA/ICH/GCP regulations and guidelines.
  • Reviews edits specifications (paper and EDC).
  • Executes EDC/IVRS User Acceptance Testing (UAT) scripts.
  • Facilitates development and review of Clinical Data Review Plan.
  • Participates in SAE reconciliation.
  • Reviews and compiles CSR and appendices.
  • Prepares and reviews material for investigator meeting and CRA Training.
  • Leads/Conducts Manager, CTM and CRA training.
  • Provides oversight of country regulatory approvals (e.g. CTA, MoH).
  • Oversees country/site IRB/EC approval.
  • Ensures appropriate country/site insurance.
  • Authorizes investigational product shipment to investigational sites, including (in association with Regulatory Affairs) the initial shipment.
  • Ensures enrollment is tracked and recorded appropriately.
  • Compiles and reports enrollment status to senior management.
  • Provides oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced).
  • Reviews and approves monitoring trip reports.
  • Follows up on outstanding eCRFs and data queries.
  • Performs co-monitoring visits to ensure data integrity and CRA performance.
  • Oversees resolution of study conduct issues.
  • Addresses site issues found during audits.
  • Compiles materials and data to support Data Safety Monitoring Board.
  • Ensures ongoing reconciliation of  TMF.
  • May have direct supervisory responsibilities for Clinical Operations staff, including work assignments, performance management, professional development, recruiting, ongoing training, and study support/oversight.

We seek candidates with the following qualifications:

  • Six years of relevant industry experience, with three years in the function.
  • Experience developing trial plans and extensive clinical research knowledge and a cross-functional understanding of clinical trial methodology. 
  • Working knowledge of the clinical drug development process is preferred.
  • This person understands current and future business trends and information in the industry.
  • This person has effective problem solving skills.
  • Knowledge of ICH/GCP and regulatory guidelines/directives is a must.
  • Ability to effectively multi-task and prioritize.
  • Financial budgeting and forecasting skills is preferred.
  • Study Tools including electronic system skills CTMS / EDC.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3199. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.