Senior Clinical Operations Manager

  • Location

    Hertfordshire, England

  • Sector:

    Healthcare

  • Job type:

    Permanent

  • Salary:

    £55000 - £60000 per annum

  • Contact:

    Experis UK

  • Contact email:

    Daniel.thorp@experis.co.uk

  • Job ref:

    PRM60SCOM_1597419345

  • Published:

    2 months ago

  • Expiry date:

    2020-09-25

  • Start date:

    ASAP

  • Client:

    #

Senior Clinical Operations Manager

Overview:

A leading pharmaceutical client is searching for a Senior Clinical Operations Manager, Oncology. Lead the cross-functional study team in managing one or more clinical studies in Oncology, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and Eisai's standard operating procedures. Manages performance and development of assigned direct report(s).

Responsibilities

  • Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome
  • Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures
  • Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
  • Called upon to develop solutions utilizing creativity and ingenuity
  • Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues
  • Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity
  • Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees

Requirements

  • Accountability for operational study level time, cost and quality deliverables
  • Manages overall study budget - for large, global or multiple regional studies
  • Coordinates all operational clinical research activities for regional / global studies
  • Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines
  • Supports the timely development and / or review of all study related documents (e.g., PCS, Protocol, CRF etc.) and operational feasibility assessments
  • Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
  • Selects / approves monitoring CROs and study sites
  • Evaluates vendor proposals against Eisai's terms and critical needs and partners with internal functions to define scope of work
  • Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians
  • Reports legal, compliance and ethical violations in a timely manner