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Clinical Study Manager

Company: Leica Biosystems
Location: Danvers
Posted on: November 26, 2022

Job Description:

Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you're helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Clinical Affairs function provides leadership on all clinical decisions related to the overall Leica Biosystems business strategy. The scope of the Clinical Study Manager is to manage and conduct a program of clinical studies and related clinical activities, to support product registrations and market access. The Clinical Study Manager works frequently with new product development core teams, clinical strategy, clinical compliance, statistics and data management staff, regulatory professionals, and Medical Affairs. The job holder reviews and supervises the work of CROs and other staff/vendors involved in the clinical research program as required.Major Responsibilities (other duties may be assigned):The Clinical Study Manager will work closely with Global Clinical Affairs leadership to ensure efficient and effective start-up, conduct and close-out of clinical trials.

  • Responsible for delivering clinical research projects and utilizing clinical systems (CTMS, eTMF, EDC) to ensure all trials, within responsibility, are delivered against agreed project milestones, budget and to expected quality.
  • Responsible for development of clinical study plans, monitoring plans and assist with clinical trial protocol development, and oversight of CRF and CSR development.
  • Responsible for assessment and selection of clinical trial sites and co-ordination of appropriate monitoring of study phases.
  • Liaise with and oversee vendors and/or Contract Research Organizations (CROs), ensuring appropriate approvals are gained and procedures followed.
  • Provides direction and task oversight to others on the clinical program team for one or more programs
  • Provides timely and high-quality preparation of assigned clinical deliverables including internal progress reports (metrics, bowlers, action plans), external reports to support regulatory submissions to the global regulatory agencies and clinical evidence intended for external audiences (e.g., abstracts, presentations, whitepapers, publications).
  • Support the development and implementation of clinical research standards, to add value to the business and improve service levels.
  • Where appropriate, represent Global Clinical Affairs at relevant cross functional project meeting(s).
  • Responsible for ensuring that clinical study related activities are carried out in accordance with the appropriate Good Clinical Practice (GCP) guidelines. This will usually be ICH GCP for medicines and ISO 14155 for Medical Devices, within the ISO quality system.
  • Establish site level budgets and contracts for studies.
  • Ensure budgets and spends are tracked and kept to forecast.
  • Assist with estimation of costs of proposed trials, recording spends during projects, and manage against internal department budget.
  • Promote health and safety policies and procedures to encourage a safe working environment.
  • Perform all activities in compliance with relevant Quality Systems Standards, SOPs and GCPs.Education and Experience:
    • BA/BS degree with at least 5 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial experience
    • Previous experience as a Clinical Research Associate or Clinical Operations role for an IVD company preferred.
    • Previous experience in creating, managing, and auditing clinical trial master files and investigator site binders
    • Knowledge of applicable clinical research regulatory requirements (ie, GCP and ICH)Travel:
      • Up to 25%#LI-KL1#LI-REMOTEWhen you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.If you've ever wondered what's within you, there's no better time to find out.

Keywords: Leica Biosystems, Boston , Clinical Study Manager, Healthcare , Danvers, Massachusetts

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