Clinical Trial Manager (CTM)

Novocure

Posted on: August 5, 2022

Closing: September 04, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

The Clinical Trial Manager (CTM) is responsible for independently overseeing all phases of global clinical trial management from initiation through closure, in accordance with applicable Standard Operating Procedures (SOPs), federal and local regulations, and ICH-GCP guidelines.

The CTM is responsible for the procedural leadership of the internal cross-functional Project Team conducting a clinical research trial, as well as the management of Contract Research Organizations (CROs) and other vendors, providing oversight of contracted deliverables and parameters. The CTM oversees investigative site feasibility, selection and start-up, clinical monitoring and site management, medical monitoring, data management and biostatistics, safety, clinical records, medical writing, supply chain, regulatory submissions, and trial finances.

The CTM is accountable for ensuring project objectives are achieved on time, within budget, and as per defined quality standards.

This is a full-time, remote-based position reporting to Senior Clinical Trial Manager.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • With minimal oversight, manages assigned clinical trials, Phases I-IV, for investigational devices in accordance with the Clinical Investigational Plan (CIP), applicable Standard Operating Procedures (SOPs), federal and local regulations, ISO standards, and ICH-GCP guidelines.
  • Leads internal and external cross-functional Project Teams, overseeing day-to-day operations, to achieve project objectives in alignment with corporate targets, i.e. enrollment, site activation, and financial performance goals
  • May be assigned as a Global Trial Lead, overseeing regional CTMs on global trials
  • Serves as the primary Sponsor contact for all project stakeholders both internally and externally, including for CROs/vendors
  • Manages CROs/vendors, when services are outsourced, providing oversight of contracted deliverables and parameters; may serve as key member of governance or oversight committees
  • Accountable for project financial planning, management, and change control, including vendor contracts and budgets, change orders and amendments, invoice review, budget reconciliations and forecasting
  • Leads the selection and contracting of vendors, including reviewing Scope of Work (SOW) in collaboration with clinical procurement
  • Provides oversight of and drives project communications across functional areas, including regular status updates, project tracking, and project reporting
  • Supports in the development and evaluation of Key Performance Indicators (KPIs) throughout the trial
  • Develops and manages the project timeline, forecasting and tracking milestones
  • Develops or oversees the development and implementation of cross-functional clinical trial documents, including but not limited to: Protocols, ICF Templates, CRFs, study plans, manuals, site-facing materials, and Clinical Study Reports (CSRs)
  • Oversees the development, maintenance, and final transfer of the electronic Trial Master File (eTMF); oversees routine TMF review
  • Oversees and/or assists with IRB/IEC and regulatory submissions and meetings as required; liaises with global team to ensure alignment with study objectives and milestones
  • Oversees internal Project Team training and tracking of training documentation
  • Performs risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses
  • Documents and escalates project and quality issues; initiates and conducts corrective/preventive actions as required
  • Collaborates internally to oversee clinical supplies and device management
  • Oversees protocol deviation management, including tracking and routine review
  • Participates in site feasibility assessment, potential investigator identification, and site selection
  • Oversees clinical monitoring and site management; reviews monitoring visit reports and conducts co-monitoring visits
  • Participates in the development of site budget templates and reviews site contracts, budgets and invoices where required
  • Supports the coordination of study-specific quality audits and regulatory authority inspections, acting as a Subject Matter Expert (SME)
  • Trains and mentors other Clinical Operations personnel, providing leadership oversight and motivation
  • Participates in the implementation of departmental Objectives and Key Results (OKRs); recommends process improvements and initiatives to enhance operations
  • Other related duties, as assigned

QUALIFICATIONS/KNOWLEDGE:

  • Bachelor’s degree from an accredited college or university, or equivalent work experience, preferably in Life Sciences required
  • Minimum of 6 years clinical research industry experience required
  • Minimum of 2 years experience in cross-functional trial management in a pharmaceutical, biotechnology, CRO, or Clinical Research Unit environment required; device trial management preferred
  • Global trial management experience preferred
  • Oncology experience preferred
  • Site monitoring experience preferred
  • Personnel management experience preferred

Knowledge

  • Knowledge of scientific experimental design and methodology, including principles and methods of basic medical and/or clinical research
  • Knowledge of global regulations, ISO standards, and ICH-GCP guidelines for the conduct of clinical trials in human subjects
  • Working knowledge of clinical trial systems (i.e. EDC, eTMF, CTMS, etc.)
  • Ability to analyze protocols and develop successful operational strategies, applying lessons learned
  • Ability to manage, review, evaluate, and report financial aspects of a project/program
  • Excellent organizational skills with strong attention to detail, precision, and accuracy
  • Excellent verbal and written communication skills, providing clear, concise, timely, and relevant information
  • Vendor and relationship management skills (i.e. CROs, central laboratories, other contractors)
  • Ability to manage and prioritize multiple tasks simultaneously, proactively problem-solve, and manage competing priorities
  • Ability to work well in a team as well as independently with limited oversight; is self-motivated and results-driven
  • Ability to identify and resolve complex challenges using critical thinking skills

 

Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

 

As part of our commitment to health and safety, COVID-19 vaccines are required for our current U.S. employees.  As an Equal Opportunity Employer it is our policy to provide reasonable accommodations to any qualified individual, who, because of a medical condition, or sincerely held religious belief/practice, receives an exemption from the vaccination requirement, if such accommodation would not result in an undue hardship for the company.

 

For more information regarding the Novocure’s COVID-19 vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition Team.

 

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

Novocure

Posted on: August 5, 2022

Closing: September 04, 2022

Salary($): Undisclosed

Position Type: Full Time

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